In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers Guidance for Industry” (“2023 Draft Guidance”). The 2023 Draft Guidance supersedes previous draft guidance from 2014 entitled “Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices” (“2014 Draft Guidance”), which was a revision of a 2009 final guidance entitled “Good Reprint ...
Our latest focus is trying to bring data to bear on common questions we get asked by clients. Last month the topic was: how well does my device need to perform to get premarket clearance from FDA? This month it is: how big does my sample size need to be for any necessary clinical trial for premarket clearance?
To date, our typical answer has been, it depends. We then explain that it’s not really a regulatory question, but a question for a statistician that is driven by the design of the clinical trial. And the design of the clinical trial is driven by the question the clinical trial is trying ...
In this episode of the Diagnosing Health Care Podcast: The U.S. Food and Drug Administration’s (FDA’s) broad definition of “misbranding” has created some industry confusion, while the Federal Trade Commission’s (FTC’s) updates to its Health Products Compliance Guidance have done the same.
In light of these recent actions, what challenges are dietary supplement manufacturers now facing?
On October 31, 2023, FDA hosted a webinar to address some of the frequently asked questions the agency has received since the September 29, 2023 release of its proposed rule on laboratory developed tests (“LDTs”). The materials from the webinar are available on FDA’s CDRH Learn webpage. Importantly, FDA announced during the webinar that the agency does not currently plan to extend the comment period for the proposed rule beyond the standard 60-day timeframe, and therefore, comments are still due on Monday December 4, 2023. In both the preamble to the proposed rule and stated ...
This month I wanted to take a data-driven look at FDA’s treatment of citizen petitions, and specifically as a starting point how quickly the agency resolves those petitions. Make no mistake, I have an interest in this topic. Over the more than 35 years I have been practicing law, I have filed multiple petitions including a 1995 petition that successfully caused FDA to adopt Good Guidance Practices. But more recently, specifically on February 6, 2023, I filed a citizen petition asking FDA to rescind its final guidance on Clinical Decision Support Software. On August 5, 2023, when we ...
In a last minute push before an anticipated government shutdown, FDA put down its marker for moving forward toward regulation of lab developed tests (“LDTs”). Unlike past proposals from FDA and Capitol Hill, FDA has taken a simple approach: laboratories that make LDTs for clinical use are manufacturing in vitro diagnostic medical devices (“IVDs”) for commercial distribution, and as such must eventually comply with FDA’s already-established IVD requirements. The FDA zeitgeist boils down to this: It doesn’t matter if the lab is large or small, for profit or ...
On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. The Final Guidance is intended to assist clinical research stakeholders, such as institutional review boards (“IRBs”), investigators, and sponsors, in complying with FDA’s informed consent regulations for clinical ...
It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance they found is adequate to obtain FDA clearance through the 510(k) process. I often respond, very helpfully, “it depends.” But for some reason clients aren’t completely satisfied by that.
I then volunteer that a general rule of thumb is 95%, but that this is just a rule of thumb. For Class II medical devices undergoing review through the 510(k) process, the legal standard is that the applicant must show that ...
In this episode of the Diagnosing Health Care Podcast: In July, the Centers for Medicare & Medicaid Services made significant headway in its implementation of the drug pricing provisions of the Inflation Reduction Act (IRA).
How can stakeholders respond to, implement, and comply with all these new provisions? On this episode, hear from special guest Sylvia Yu, Vice President and Senior Counsel of Federal Programs at PhRMA.
Sylvia and Epstein Becker Green attorneys Connie Wilkinson and Alexis Boaz discuss the recent updates on the quickly moving implementation of the drug pricing provisions under the IRA and the industry’s response.
As discussed in our June Insight, earlier this year FDA publicly announced its development of a proposed rule that would expressly define laboratory developed tests (“LDTs”) as medical devices and subject them to the agency’s regulatory authority. Such a rule would be FDA’s first comprehensive attempt to impose its authority over LDTs since its 2014 draft guidance, which FDA ultimately chose not to finalize, and comes after several failed congressional legislative attempts to do the same.
Would it surprise you if I told you that a popular and well-respected machine learning algorithm developed to predict the onset of sepsis has shown some evidence of racial bias? How can that be, you might ask, for an algorithm that is simply grounded in biology and medical data? I’ll tell you, but I’m not going to focus on one particular algorithm. Instead, I will use this opportunity to talk about the dozens and dozens of sepsis algorithms out there. And frankly, because the design of these algorithms mimics many other clinical algorithms, these comments will be applicable to clinical algorithms generally.
In prior posts here and here, I analyzed new data obtained from FDA through the Freedom of Information Act about FOIA requests. I looked at response times and then started to dive into the topics that requesters were asking about. This is the third and final post on this data set, and it builds on the last post by taking the topics identified there to explore success rates by topic. From there, I look at who is asking about those topics and how successful those individual companies are in their requests.
In this episode of the Diagnosing Health Care Podcast: A complex landscape of state laws overlays the direct access testing model, ranging from physician order requirements, such as telemedicine standards and the corporate practice of medicine doctrine, to specimen collection considerations, including how the varying options for collection could impact a model.
How do these factors combine to create a roadmap for companies navigating the direct access testing industry?
In this episode of the Diagnosing Health Care Podcast: Renewed interest in the potential benefits of psychedelic treatments has led to an upsurge in research. Is the first FDA approval of a psychedelic for therapeutic use on the horizon?
Continuing my three-part series on FOIA requests using a database of over 120,000 requests filed with FDA over 10 years (2013-22), this month’s post focuses on sorting the requests by topic and then using those topics to dive deeper into FDA response times. In the post last month, I looked at response times in general. This post uses topic modeling, a natural language processing algorithm I’ve used in previous blog posts, including here and here, to discern the major topics of these requests.
In a March 6, 2023 constituent update, the U.S. Food and Drug Administration (“FDA”) announced the launch of its new Dietary Supplement Ingredient Directory (the “Directory”), which the agency describes as “a one stop shop of ingredient information that was previously found on different FDA webpages.” According to the FDA, the Directory is “intended to help manufacturers, retailers, and consumers stay informed about ingredients that may be found in products marketed as dietary supplements and quickly locate information about such ingredients on the FDA’s website.” With the release of the Directory, the FDA is now retiring the “FDA Dietary Supplement Advisory Ingredient List.”
On February 22, 2023, the U.S. Food and Drug Administration (“FDA”) announced a much-anticipated draft guidance regarding the naming and labeling of plant-based milk alternatives. Significantly, under the draft guidance, FDA will not prohibit the use of the identifier “milk” in plant-based milk alternatives but does recommend the product be labeled with “voluntary nutrient statements” to help consumers understand the nutritional differences in the products.
Over the past decade, plant-based milk alternatives have dramatically increased in both availability and consumption. During this time, industry stakeholders have disagreed over the use of the term “milk” for plant-based alternatives that do not contain milk from cows. The dairy industry has lobbied both federal and state governments to restrict the use of “milk” to only fluid “obtained by the complete milking of one or more healthy cows.” To address this debate and to acknowledge the exponential increase in the sale of plant-based milk products, FDA issued a notice for public comment in September 2018 on the “Use of Name of Dairy Foods in the Labeling of Plant-Based Products” that amassed over 13,000 comments. The recently issued draft guidance indicates that the agency did in fact rely on the findings from this notice in developing its recommendations.
Federal agencies in health care publish large amounts of data, and my posts typically analyze that data. To provide more value to readers, I’ve started submitting FOIA requests for unpublished data to produce additional insights into how FDA works. And what better first topic than data on FDA responses to FOIA requests.
Information is important, and thus so is access to it. Our democracy needs to know what’s going on in our government, and businesses trying to navigate the FDA regulatory process likewise need to understand the regulatory process. For both purposes, the FOIA process should be fair and efficient.
FDA has been releasing data on its FOIA process, specifically its FOIA logs, for a few years. For data analysis purposes, those data are missing some important fields such as the date of the final decision. Further, when it comes to looking at the data on the closed cases, the data only go back four years. In my experience, the pandemic years were anomalous in so many ways that we can’t treat any data from the last three years as typical. As a result, I wanted to go back 10 years.
Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA banned Beluga caviar. If you are interested in Beluga caviar, would you think you had adequate opportunity to comment? Would you care if FDA argued that Beluga caviar was high in cholesterol so the two documents were related?
The Food and Drug Administration (FDA) recently issued both draft and final guidance regarding food allergen labeling requirements. The draft guidance document, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5), updates the previous (fourth) edition with new and revised guidance concerning food allergen labeling. FDA also issued a final guidance document with the same title in order to preserve questions and answers that were unchanged from the previous (fourth) edition, which was published in 2004 and last updated in 2006.
On January 24, 2023, FDA published a notice in the Federal Register entitled, “Clarification of Orphan-Drug Exclusivity Following Catalyst Pharms., Inc. v. Becerra.” In brief, the Catalyst decision by the 11th Circuit Court of Appeals concerned FDA’s application of the Orphan Drug Act (21 USC 360cc(a)), and in particular the extent of the 7-year orphan drug market exclusivity (ODE) provided with an orphan drug’s approval. The ODE, per the Orphan Drug Act prevents FDA from approving another applicant’s same drug for “the same disease or condition.”
The regulatory environment at the US Food and Drug Administration (“FDA”) has a tremendous impact on how companies operate, and consequently data on that environment can be quite useful in business planning. In keeping with the theme of these posts of unpacking averages, it’s important to drill down sufficiently to get a sense of the regulatory environment in which a particular company operates rather than rely on more global averages for the entire medical device industry. On the other hand, getting too specific in the data and focusing on one particular product category can prevent a company from seeing the forest for the trees.
Recently, I was asked by companies interested in the field of digital medical devices used in the care of people with diabetes to help them assess trends in the regulatory environment. To do that, I decided to create an index that would capture the regulatory environment for medium risk digital diabetes devices, trying to avoid getting too specific but also avoiding global data on all medical devices. In this sense, the index is like any other index, such as the Standard & Poor 500, which is used to assess the economic performance of the largest companies in terms of capitalization. My plan was to first define an index of product codes for these medium risk digital diabetes products, then use that index to assess the regulatory environment in both premarket and postmarket regulatory requirements.
It is certainly easy, when writing code to accomplish some data science task, to start taking the data on face value. In my mind, the data can simply become what they claim to be. But it’s good to step back and remember the real world in which these data are collected, and how skeptical we need to be regarding their meaning. I thought this month might be an opportunity to show how two different FDA databases produce quite different results when they should be the same.
The motivation for this month’s post was my frustration with the techniques for searching the FDA’s 510(k) database. Here I’m not talking about just using the search feature that FDA provides online. Instead, I have downloaded all of the data from that database and created my own search engine, but there are still inherent limitations in what the data contain and how they are structured. For one, if you want to submit a premarket notification for an over-the-counter product, it really isn’t easy to find predicates that are specifically cleared for over-the-counter without a lot of manual work.
To see if I could find an easier way, I decided to use the database FDA maintains for unique device identifiers, called the Global Unique Device Identification Database (GUDID). You can search that database using the so-called AccessGUDID through an FDA link that takes you to the NIH where the database is stored. That site only allows for pretty simple search, so for what I needed to do, I downloaded the entire database so I could work directly on the data myself.
While the UDI database is enormous at this juncture (over 3 million products), what I found left me with questions about just how comprehensive and complete the data are. At the same time, it seems like a good way to supplement the information that can be gleaned from the 510(k) database.
Over the spring and summer, I did a series of posts on extracting quality information from FDA enforcement initiatives like warning letters, recalls, and inspections. But obviously FDA enforcement actions are not the only potential sources of quality data that FDA maintains. FDA has what is now a massive data set on Medical Device Reports (or “MDRs”) that can be mined for quality data. Medical device companies can, in effect, learn from the experiences of their competitors about what types of things can go wrong with medical devices.
The problem, of course, is that the interesting data in MDRs is in what a data scientist would call unstructured data, in this case English language text describing a product problem, where the information or insights cannot be easily extracted given the sheer volume of the reports. In calendar year 2021, for example, FDA received almost 2 million MDRs. It just isn’t feasible for a human to read all of them.
That’s where a form of machine learning, natural language processing, or more specifically topic modeling, comes in. I used topic modeling last November for a post about major trends over the course of a decade in MDRs. Now I want to show how the same topic modeling can be used to find more specific experiences with specific types of medical devices to inform quality improvement.
A private equity client asked us recently to assess a rumor that FDA was on the warpath in enforcing the 510(k) requirement on medical devices from a particular region. Such a government initiative would significantly deter investments in the companies doing the importing. Turns out, the agency was not. The FDA’s recent activities in the region were well within their historical norms.
But the project got us thinking, what does the agency’s enormous database on import actions tell us about the agency’s enforcement priorities more generally? There are literally thousands of ways to slice and dice the import data set for insights, but we picked just one as an example. We wanted to assess, globally, over the last 20 years, in which therapeutic areas has FDA been enforcing the 510(k) requirement most often?
You might be thinking, that’s an odd title: obviously FDA’s breakthrough device designation is helpful. However, after looking at the data, my conclusion is that I would avoid the breakthrough device designation for any product that qualifies for the 510(k) process. The process is likely not helpful for such devices.
[Update - August 3, 2022: See the bottom of this post.]
Recalls have always been a bit of a double-edged sword. Obviously, companies hate recalls because a recall means their products are defective in some manner, potentially putting users at risk and damaging the brand. They are also expensive to execute. But a lack of recalls can also be a problem, if the underlying quality issues still exist but the companies are simply not conducting recalls. Recalls are necessary and appropriate in the face of quality problems.
Thus, in terms of metrics, medical device companies should not adopt as a goal reducing recalls, as that will lead to behavior that could put users at risk by leaving bad products on the market. Instead, the goal should be to reduce the underlying quality problems that might trigger the need for recall.
What are those underlying quality problems? To help medical device manufacturers focus on the types of quality problems that might force them to conduct a recall, we have used the FDA recall database to identify the most common root causes sorted by the clinical area for the medical device.
Most companies want to avoid FDA warning letters. To help medical device companies identify violations that might lead to a warning letter, this post will dive deeply into which specific types of violations are often found in warning letters that FDA issues.
As you probably know, FDA has a formal process for evaluating inspection records and other materials to determine whether issuing a warning letter is appropriate. Those procedures can be found in chapter 4 of FDA’s Regulatory Procedures Manual. Section 4-1-10 of that chapter requires that warning letters include specific legal citations, in addition to plain English explanations of violations. The citations are supposed to make reference to both the statute and any applicable regulations.
As a consequence, to understand the content of the warning letters, we need to search for both statutory references as well as references to regulations. Because statutes are deliberately drafted to be broader in their language, references to the regulations tend to be more meaningful.
Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. During that time, FDA has also asserted that it has the authority to regulate in-house tests developed and performed by CLIA-certified, high-complexity clinical laboratories (generally referred to as laboratory-developed tests or LDTs) but chose as a matter of enforcement discretion not to regulate LDTs. Over time, the Agency chipped away slowly at LDT enforcement discretion, carving out certain kinds of tests (e.g., direct-to-consumer LDTs) and thus making them subject to regulation, but by and large did not take broad steps to regulate LDTs.
Much like the ambiguous landscape involving cannabidiol (CBD) products on the consumer market, an influx of delta-8 THC containing products for consumption has highlighted a recurrent regulatory issue surrounding the legality of hemp derived products at the federal level. The Agricultural Improvement Act of 2018 (the “2018 Farm Bill”), which, among other things, offered a federal definition of hemp and removed it from the list of Schedule I controlled substances, specifically carved out hemp derived products with less than 0.3% delta-9-tetrahydocannabinol (THC) on a dry weight basis, thereby allowing products that meet this definition to flood the consumer markets.
In this month’s post, in the medical device realm I explore what kinds of inspection citations most often precede a warning letter. In this exercise, I do not try to prove causation. I am simply exploring correlation. But with that caveat in mind, I think it’s still informative to see what types of inspectional citations, in a high percentage of cases, will precede a warning letter. And, as I’ve said before, joining two different data sets – in this case inspectional data with warning letter data – might just reveal new insights.
This month’s post focuses on how timely FDA decisions are in categorizing new diagnostics under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). The answer is that, on average, the agency does okay, but they also sometimes may miss their own guideline by a wide margin. I use the word “may” there because the FDA data set is inadequate to support a firm conclusion. I’ll explain more about that below, but this is another case of FDA releasing incomplete data that frustrates data analytics.
I recommend against relying on any data I provide in today’s post. I hope the data are at least somewhat accurate. But they are not nearly as accurate as they should be, or as they could be, if FDA just released a key bit of information they have been promising to share for years.
One of the ways data scientists can provide insights is by grafting together data from different sources that paint a picture not seen elsewhere. What I want to do is join the clinical trial data at www.clinicaltrials.gov with the data maintained by FDA of approved drugs, called drugs@FDA. But I can’t, at least not with much accuracy.
The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an appropriate cross-section of Americans. Clinical evidence has shown that there are significant differences among the races that impact the safety and effectiveness we can expect from a particular drug or device, and consequently FDA has concluded testing and labeling to identify those racial differences are important. The question for today is, how are we doing in achieving racial diversity in clinical trials involving drugs?
On January 11, 2022, the Centers for Medicare and Medicaid Services (“CMS”) published an anticipated proposed National Coverage Determination (“NCD”) decision memorandum that begins the process of determining whether the Medicare program will cover FDA-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s Disease. (https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=305).
The proposed decision, which is subject to public comments that are due to CMS by February 10, 2022, does not endorse nationwide Medicare coverage for these drugs. Instead, CMS chose an alternate pathway known as Coverage with Evidence Development (“CED”). If the proposal is adopted by CMS, it would set in motion a detailed regulatory process that includes temporary Medicare coverage for the drug but only for certain Medicare beneficiaries who are enrolled in an additional clinical trial intended to test whether these drugs will have a significant benefit for Medicare beneficiaries. CMS expects to issue a decision by April 11, 2022 to approve or reject the CED process after reviewing comments from interested parties.
It is common for FDA and others to show a map of the United States with the states color-coded by intensity to showcase the total number of inspections done in that state. Indeed, FDA includes such a map in its newly released dashboard for FDA inspections. In reviewing that map with the U.S. map color-coded to reflect where medical device establishments are located, do you notice anything? Not to destroy the suspense for you, but it turns out that FDA tends to inspect where medical device inspection facilities are located. Really.
We wanted to get beneath those numbers in two ways. First, it’s much more informative to look at the data at a county level because there’s actually quite a bit of variation county by county. Second, and more importantly, we wanted to normalize the inspection data by the number of facilities. In other words, by looking at inspections per facility, we can get a better sense of the inspection frequency in each county.
This month, we’re going to look at a visualization that uses network techniques. Visualizing a network is a matter of nodes and edges. If the network were Facebook, the nodes would be people, and the edges would be the relationships between those people. Instead of people, we are going to look at specific device functionalities as defined by the product codes. And instead of relationships, we are going to look at when device functionalities (i.e., product codes) are used together in a marketed device as evidenced by a 510(k) submission.
While this column typically uses data visualizations you’ve probably seen before, I want to introduce one that perhaps you have not. This is in the realm of text analysis. When looking at FDA data, there are numerous places where the most interesting information is not in a data field that can be easily quantified, but rather in narrative text. Take, for example, Medical Device Reports of adverse events, or “MDRs.” While we can do statistical analysis of MDRs showing, for example, which product categories have the most, the really interesting information is in the descriptions ...
In this column, in the coming months we are going to dig into the data regarding FDA regulation of medical products, deeper than the averages that FDA publishes in connection with its user fee obligations. For many averages, there’s a high degree of variability, and it’s important for industry to have a deeper understanding. In each case, we will offer a few preliminary observations on the data, but we would encourage a conversation around what others see in the data.
This is an interactive chart that you can explore by clicking on the colors in the legend to see how specific ...
In this episode of the Diagnosing Health Care Podcast: Federal and state cannabis regulation and enforcement appear to be moving in different directions. While the Food and Drug Administration (“FDA”) has broadened its net to target businesses making claims that their products can treat specific conditions, a growing number of states have passed bills that, among other things, legalize adult-use cannabis.
Earlier this summer, Ethan P. Davis, Principal Deputy Assistant Attorney General for the Civil Division of the U.S. Department of Justice (DOJ) delivered remarks addressing DOJ’s top priorities for enforcement actions related to COVID-19 and indicating that DOJ plans to “vigorously pursue fraud and other illegal activity.” As discussed below, Davis’s remarks not only highlighted principles that will guide enforcement efforts of the Civil Fraud Section under the False Claims Act (FCA) and of the Consumer Protection Branch (CPB) under the Food, Drug, and Cosmetic Act (FDCA) and the Controlled Substances Act (CSA) in response to the COVID-19 public health emergency (PHE), they also provide an indication of how DOJ might approach enforcement over the next few years.
DOJ'S KEY CONSIDERATIONS & ENFORCEMENT STRATEGY FOR COVID-19
Davis highlighted two key principles that would drive DOJ’s COVID-related enforcement efforts: the energetic use of “every enforcement tool available to prevent wrongdoers from exploiting the COVID-19 crisis” and a respect of the private sector’s critical role in ending the pandemic and restarting the economy. Under that framework, DOJ plans to pursue fraud and other illegal activity under the FCA, which Davis characterizes as “one of the most effective weapons in [DOJ’s] arsenal.”
However, as DOJ pursues FCA cases, it will also seek to affirmatively dismiss qui tam claims that DOJ finds meritless or that interfere with agency policy and programs. DOJ also plans to collect certain information from qui tam relators regarding third-party litigation funders during relator interviews. DOJ’s emphasis on qui tam cases—cases brought under the FCA by relators or whistleblowers—for COVID-related enforcement highlights the impact such matters have on DOJ’s enforcement agenda.
- DOJ will consider dismissing cases that involve regulatory overreach and are not otherwise in the interest of the United States.
Although Davis emphasized that the majority of qui tam cases would be allowed to proceed, in order to “weed out” cases that lack merit or that DOJ believes should not proceed, DOJ will consider dismissing cases that “involve regulatory overreach or are otherwise not in the interest of the United States.” This is consistent with the principles reflected in the 2018 Granston Memo that instructed DOJ attorneys to consider “whether the government’s interests are served” when considering whether cases should proceed and listed considerations for seeking alternative grounds for dismissal of FCA cases. Davis gave examples throughout his speech of actions DOJ might consider dismissing:
- Cases based on immaterial or inadvertent mistakes, such as technical mistakes with paperwork
- Cases based on honest misunderstandings of rules, terms, and conditions
- Cases based on alleged deviations from non-binding guidance documents
- Cases against entities that reasonably attempted to comply with guidance and “in good faith took advantage of the regulatory flexibilities granted by federal agencies in the time of crisis.”
DOJ litigators have been advised to inform relators of the possibility of dismissal. Additionally, qui tam suits based on behaviors temporarily permitted during the COVID-19 pandemic, particularly in circumstances in which agencies exercised discretion to waive or not enforce certain requirements, might
“fail as a matter of law for lack of materiality and knowledge.”
- DOJ will now include a series of questions during relator interviews to identify third-party litigation funders.
During each relator interview, DOJ has instructed line attorneys to ask a series of questions to identify whether the relator or their counsel has a third-party litigation funding agreement, which is an agreement in which a third party—such as a commercial lender or a hedge fund—finances the cost of litigation in return for a portion of recoveries. Under the new policy detailed in Davis’s speech, if a third-party funder is disclosed, DOJ will ask for the following:
- the identity of the third-party litigation funder,
- information regarding whether information of the allegations has been shared with the third party,
- whether the relator or their counsel has a written agreement with the third party, and
- whether the agreement between the relator or their counsel and the third party includes terms that entitles the third-party funder to exercise direct or indirect control over the relator’s litigation or settlement decisions.
Relators must inform DOJ of changes as the case proceeds through the course of litigation. While Davis characterizes these changes as a “purely information-gathering exercise for the purpose of studying the issues,” the questions are in furtherance of DOJ’s ongoing efforts to uncover the potential negative impacts third-party litigation financing may have in qui tam actions.  The questions Davis referenced in his remarks reflect DOJ’s concerns with third-party litigation funding as expressed by Deputy Associate Attorney General Stephen Cox in a January 2020 speech. Davis emphasized that DOJ particularly sought to evaluate the extent to which third-party litigation funders were behind qui tam cases DOJ investigates, litigates, and monitors; the extent of information sharing with third-party funders; and the amount of control third-party funders exercised over the litigation and settlement decisions. While the Litigation Funding Transparency Act of 2019 has remained inactive since its introduction in February 2019 by Senator Grassley and the 2018 proposal by the U.S. Court’s Advisory Committee on Civil Rights’ Multidistrict Litigation Subcommittee to require disclosure of third-party litigation funding remains under consideration, DOJ’s plans to include this line of questioning potentially signals DOJ’s intention to take more concrete and significant steps to address third-party litigation funding in the future.
FDA took two important steps last week to clarify the regulatory landscape for cannabis products, including CBD products. First, FDA issued a draft guidance on Quality Considerations for Clinical Research Involving Cannabis and Cannabis Derived Compounds. This guidance builds off of earlier guidance FDA has issued about the quality and regulatory considerations that govern the development and FDA approval of cannabis and/or cannabinoid drug products. See e.g., here and here. The draft guidance iterates a federal standard for calculating delta-9 THC content in cannabis finished products, which addresses a significant gap in federal policy regarding those products. While the testing standard is neither final nor binding on FDA or DEA, when finalized it would iterate what FDA considers to be a scientifically valid method for making the determination of whether a cannabis product is a Schedule I controlled substance. Therefore, it may be useful in many contexts, including federal and state cannabis enforcement actions. We encourage affected parties to file comments on FDA’s Guidance, which they may do until September 21, 2020.
Second, FDA sent to the Office of Management and Budget for review a proposal on how FDA intends to exercise enforcement discretion over CBD consumer products. See here. While the contents of this guidance have not yet been made public, we forecast that it likely will align with FDA’s past enforcement actions and memorialize the agency’s intent to pursue enforcement actions against CBD consumer product companies that make egregious claims about their products treating or preventing serious diseases or conditions.
Guidance on Considerations for Cannabis Clinical Research
FDA’s guidance recognizes that Congress’s enactment of the Agricultural Improvement Act of 2018 (“2018 Farm Bill”) improved domestic access to pre-clinical and clinical cannabis research material that may be used in the research and development of novel therapies. However, currently marijuana only may be obtained domestically from the University of Mississippi under contract with the National Institute on Drug Abuse. While DEA issued a policy in 2016 to allow for the additional registration of marijuana cultivators for legitimate research and licit commercial purposes, the Office of Legal Counsel in June 2018 issued an opinion finding that such policy violates the United States’ obligations under applicable treaties. However, in March of this year, DEA issued a proposed rule to allow for the registration of additional cultivators of cannabis for these licit purposes. See here.
There is an alternative pathway to the procurement of Schedule I research material which FDA’s guidance does not mention: importation. Researchers may obtain certain Schedule I material pursuant to a federal DEA Schedule I importer registration, and DEA has in the past issued such registrations. See 21 CFR 1301.13(e)(1)(viii).
On July 20, 2020, the United States Food and Drug Administration (FDA) announced a six-month extension of its enforcement discretion policy for certain regenerative medicine products requiring pre-market review due to the COVID-19 pandemic. Included in a final guidance document entitled, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use,” this extension will give manufacturers additional time to determine whether they need to submit an investigational new drug (IND) or marketing ...
On March 18, 2020, the United States Food and Drug Administration (FDA) announced the suspension of all domestic routine surveillance facility inspections until further notice. FDA took this measure to protect the health and well-being of its staff and those who conduct the inspections for the agency under contract at the state level, and due to industry concerns regarding visitors. During this interim period, the FDA conducted only a limited number of mission critical inspections using a risk-based approach. On July 10, 2020, FDA announced its plans to resume on-site inspections ...
The cannabidiol (“CBD”) consumer product marketplace is booming. And, while FDA has maintained its position that CBD, even hemp-derived CBD, may not be included as an ingredient in conventional foods or dietary supplements, FDA has signaled its intent to create a lawful marketing pathway for these products. Also, while FDA has issued Warning Letters to companies who made egregious claims about their products curing serious diseases and conditions like Alzheimer’s disease and cancer, FDA has also signaled a willingness to exercise enforcement discretion over CBD products that pose less serious safety concerns. What has resulted is CBD manufacturers, retailers, and other businesses living in FDA regulatory purgatory. Fortunately, several courts have recently held that CBD companies will not face consumer product liability, at least while their FDA regulatory fate is being decided.
A number of federal lawsuits were recently brought by consumers against manufacturers of various types of CBD products, ranging from ingestible foods and beverages, dietary supplements, topical oils and sprays, and vape products. The plaintiffs in these cases all bring similar claims, that the products purchased were misleading as to the amount of CBD in the product and/or that the products were mislabeled and falsely advertised as dietary supplements. The plaintiffs’ claims are based, at least in part, on assertions that the defendants violated the federal Food, Drug, and Cosmetic Act (“FD&C Act”) by introducing adulterated and misbranded products into the U.S. market.
However, over the course of 2020, at least three judges have found that the outcome of these cases will have to wait until FDA completes its rulemaking on the regulation of CBD products. Citing the primary jurisdiction rule, the judges each issued a stay on their respective cases. The judges found that FDA has primary oversight over claims involving the illegal sale or marketing of CBD products, and that regulatory clarity is needed before a decision may be made on the matters brought by the plaintiffs. Thus, the fate of these cases now depend on when and whether FDA will issue regulations governing CBD products.
FDA recently published its “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry” (“Guidance”) which provides suggestions on managing the potential risk of products being contaminated by SARS-CoV-2, the virus behind COVID-19 infections for drug and biological product manufacturers, 503B outsourcing facilities, and 503A compounding pharmacies.
The Guidance builds on the current Good Manufacturing Practices (cGMPs) regulations for drugs and biological products, which require personnel with an illness that could adversely affect drug safety or quality be excluded from direct contact with drugs and drug components used in manufacturing. As the Guidance states, preliminary research indicating that SARS-CoV-2 “is stable for several hours to days in aerosols and on surfaces,” and that it has an incubation period of 2 to 14 days, which are both factors that increase the risk of spread and introduction into products. The actual health risk is hard to calculate – FDA itself notes that there have not been documented transmissions through pharmaceuticals to date. The regulatory risk, however, is an easier formula – FDA has a clear expectation that drug and biological product manufacturers evaluate the potential for COVID-19 contamination of their products under existing controls, or risk being out of compliance with cGMPs.
As an update to our prior blog post, on April 20, 2020 FDA announced the authorization of the first COVID-19 test for home collection of specimens. This announcement, made via the Agency’s FAQs on Diagnostic Testing for SARS-CoV-2 webpage, comes after weeks of FDA reporting that it has been working closely with manufacturers on such a test during the weekly Virtual Town Hall Meetings hosted by the Center for Devices and Radiological Health. FDA clarifies that the test is only authorized for home collection of specimens to be sent back to a laboratory for processing. FDA still has not authorized a COVID-19 test “to be completely used and processed at home.”
According to the Emergency Use Authorization (EUA) letter for the test, the new home collection method involves the use of a nasal swab, as opposed to a nasopharyngeal swab. Home collection is only permitted “when determined by a healthcare provider to be appropriate based on results of a COVID-19 questionnaire.” Instructions for self-collection must be made available to individuals online or as part of the collection kit, and the kit must include materials allowing the patient to safely mail the specimen to an authorized laboratory. The letter states that the EUA will be in effect until there is a declaration that the circumstances justifying this authorization is terminated or revoked.
On Friday, March 27, 2020, FDA issued an update to previous guidance titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”), adding an Appendix with ten questions and answers for specific topics based on feedback received on the initial March 18th Guidance. To supplement our prior blog post, we identify some key takeaways from the updated Guidance below:
Prioritize Safety of Clinical Trial Participants
- Ongoing Clinical Trials. Sponsors, investigators, and IRBs should work together to assess whether the participants’ safety is better served by continuing the study as is, discontinuing administration or use of the product, or by ending participation in the trial. The Guidance provides a number of key factors for consideration. FDA also recognizes that there may be an investigational product that is providing benefit to a trial participant, and the sponsor must decide whether to continue administration during the COVID-19 pandemic. This is a context-dependent choice, and sponsors should consider whether there are any reasonable alternative treatments available, the seriousness of the disease or condition, the risks involved in switching treatment, supply chain disruptions, and whether discontinuing administration would pose a substantial risk to the participant.
- New Clinical Trials. With respect to initiating a new clinical trial, other than one to investigate treatments or vaccines related to COVID-19 infection, FDA advises sponsors to consider the ability to effectively mitigate the risks of a trial in order to preserve safety of the participants and trial integrity. Any new trial must also be designed in a way to comply with the Federal and State public health measures implemented in response to COVID-19.
On March 16, 2020, FDA finalized its guidance titled Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Policy”). The Policy includes information and recommendations to assist laboratories and commercial manufacturers in development of diagnostic tests for the novel coronavirus (“COVID-19”) during the ongoing pandemic.
During the first week of implementation, questions arose regarding the extent to which the Emergency Use Authorization (“EUA”) pathway to market, as described by the Policy, covers at-home ...
On March 22, 2020, the U.S. Food and Drug Administration (“FDA”) issued guidance, for immediate implementation, that aims to increase the availability of ventilators and other respiratory devices needed to address the COVID-19 pandemic. While FDA urges health care facilities to use, wherever possible, FDA-cleared standard full-featured ventilators to treat COVID-19 patients (as well as other patients requiring ventilatory support), FDA will allow a more flexible approach to modifications to these devices to help boost manufacturing capacity and supply. FDA also took the opportunity to lay out guidelines that encourage submission of Emergency Use Authorization (“EUA”) applications for devices not marketed in the United States, continuing an unprecedented Agency response to the pandemic.
Specifically, FDA will allow manufacturers of certain FDA-cleared ventilator/respiratory devices (as detailed in the table below) to make modifications to the indications, claims, functionality, or to the hardware, software, or materials of the device without making a new 510(k) submission to FDA, so long as the modification will not create undue risk in light of the public health emergency. Such changes, which would normally require a new 510(k), could include a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.
On Wednesday, March 18, 2020, the Food and Drug Administration (“FDA”) issued a guidance document titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”). FDA’s stated purpose in issuing the guidance is to help sponsors to assure the safety of trial participants, maintain compliance with good clinical practice (“GCP”), and minimize risk to the integrity of trials during the ongoing Coronavirus Disease 2019 (“COVID-19”) pandemic.
The Guidance recognizes the impact COVID-19 may have on the conduct of ongoing clinical trials, including quarantines, site closures, travel limitations, interruptions to the supply chain, and other considerations should individuals involved in the studies become infected with COVID-19. FDA acknowledges that these factors may impact a sponsor’s ability to meet protocol-specified procedures, and that protocol modifications may be necessary and deviations unavoidable.
On March 17, 2020, the U.S. Food and Drug Administration (“FDA”) issued a Temporary Policy regarding preventive controls and food supplier verification audit requirements during the COVID-19 public health emergency. This guidance explains the current intent of FDA to not enforce onsite audit requirements in certain circumstances related to the impact of COVID-19. Such onsite audit requirements can be found in three important food regulations:
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR Part 117);
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507); and
- Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (21 CFR Part 1 Subpart L).
The Agency has stated that this temporary guidance will become effective immediately, without comment from the public, due to the exigent circumstances surrounding this ongoing public health threat.
Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under Which Homeopathic Drugs May Be Marketed, and, concurrently, published revised draft guidance titled Drug Products Labeled as Homeopathic (the “Revised Homeopathic Draft Guidance”).
Homeopathy—an alternative medical approach that began in the late 18th century—is based on the belief that (1) a substance that causes symptoms in a healthy ...
Earlier this month, the FDA released programmatic guidance intended to clarify the current review practices for the Humanitarian Device Exemption (“HDE”) Program (“Guidance”) reflecting recent changes in the HDE Program resulting from statutory amendments made by the 21st Century Cures. The Guidance addresses frequently asked questions about FDA actions on HDE applications, post-approval requirements, and includes a filing checklist to clarify the required information for the FDA to consider whether an HDE application is ready for substantive review.
Interoperability and patient access to data has been pushed to the forefront as a primary concern for the health industry. This is largely due to proposed rules published this spring by the Office of the National Coordinator for Health Information Technology (ONC) and the Center for Medicare and Medicaid Services (CMS) that seek to advance interoperability and support the access, exchange, and use of electronic health information. In August 2019, the ONC held its third annual National Coordinator for Health IT Interoperability Forum in Washington DC. The event brings together the ...
In an effort to address the challenge of increasing drug prices for patients and families, the U.S. Food and Drug Administration (“FDA”) and the U.S. Department of Health and Human Services (“HHS”) recently outlined a proposal for facilitating the importation of pharmaceuticals originally intended for foreign markets. The Safe Importation Action Plan (the “Action Plan”), jointly announced on July 31, 2019, describes two different potential pathways for importing certain drugs. The Action Plan offers only a limited overview of the proposed pathways and does not ...
There is little question that youth e-cigarette use has been on the rise. In 2018, an estimated 3.6 million kids reported “current use” of e-cigarettes (defined as use on at least one day in the past 30 days), up from just 220,000 kids reporting such use in 2011 (See National Youth Tobacco Survey findings). Although youth e-cigarette use raises public health concerns, there’s also a public health upside to e-cigarettes, as they have been shown to be an effective tool in helping current adult cigarette smokers kick the habit and are a safer option for current smokers than ...
On July 11, 2019, a Federal judge for the U.S. District Court for Maryland ruled that manufacturers and importers of products such as e-cigarettes and other electronic nicotine delivery systems (“ENDS”) have ten months to submit applications for marketing to the U.S. Food and Drug Administration (“FDA”). The ten-month deadline is applicable to new tobacco products on the market as of the August 8, 2016 deeming rule that extended FDA’s regulatory jurisdiction to include all tobacco products. Accordingly, manufacturers of e-cigarettes now have until May 2020 to submit ...
On May 31, 2019, the U.S. Food and Drug Administration (“FDA”) hosted its much-anticipated public hearing titled “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds” (discussed in our prior blog post). The day-long hearing presented an opportunity for FDA panel members to engage directly with stakeholders on the regulatory future of cannabis or cannabis-derived products within the scope of FDA’s jurisdiction.
Acting FDA Commissioner Ned Sharpless, M.D., kicked off discussions, reminding the panel and ...
When we think about the top players in the medical device development space, we often see device company sponsors, clinicians, scientists, and FDA regulators as the ones driving the process. But what about the patient perspective? Does that get factored in?
On May 3, 2019, FDA established a docket to collect public input on a proposed list of patient preference-sensitive areas for medical device review, and posed certain related questions (comments are due July 2, 2019). By identifying these key areas (which it committed to as part of the reauthorization of the Medical Device User Fee ...
Following a two-day meeting by a Food and Drug Administration (“FDA”) advisory committee on breast implant safety earlier this year, FDA on May 2, 2019, released a statement announcing that no breast implant models will be banned from the U.S. market at this time. Also described in the statement are a number of measures the agency is undertaking in order to assist women in making more informed decisions regarding breast implants.
The March 26, 2019, meeting of the General and Plastic Surgery Devices Panel was convened to discuss issues and concerns related to the benefit-risk ...
On March 27, 2019, the FDA announced that it would be proposing new amendments to key regulations regarding mammography facilities that would require these entities “to tell women more about how dense breast tissue can affect their health and increase their cancer risk.” The proposed changes to mammography facility regulations would be the first issued in more than 20 years. The FDA believes the change will “expand the information mammography facilities must provide to patients and health care professionals, allowing for more informed medical decision-making.” In ...
On April 2, 2019, FDA issued a press release featuring a statement from FDA Commissioner Scott Gottlieb announcing the Agency’s latest enforcement actions taken against companies engaging in unlawful marketing of cannabidiol (CBD) products. Coming just days before Gottlieb’s anticipated departure from the Agency, this news otherwise is unsurprising given recent events on the federal and state level. In a December 2018 press release issued on the heels of the Farm Bill’s passage, FDA forecast its intention to step up enforcement against CBD products, and earlier this year ...
Many physicians rely on publicly available reports to assess the safety of the devices they use on patients, but in some cases, these reports aren’t painting the full picture. A recent Kaiser Health News (“KHN”) article raises serious questions about FDA’s practice of allowing a significant number of medical device injury and malfunction reports to stay out of the public eye.
Under FDA’s Medical Device Reporting (“MDR”) regulation (21 CFR part 803), device manufacturers, importers, and device user facilities (which include hospitals, ambulatory surgery ...
One well-recognized way to protect patient privacy is to de-identify health data. However, trends around increases in publicly-available personal data, data linking and aggregation, big data analytics, and computing power are challenging traditional de-identification models. While traditional de-identification techniques may mitigate privacy risk, the possibility remains that such data may be coupled with other information to reveal the identity of the individual.
Last month, a JAMA article demonstrated that an artificial intelligence algorithm could re-identify ...
On February 15, 2019, the U.S. Food and Drug Administration (“FDA”) finalized two guidance documents regarding regenerative medicine therapies (see FDA’s announcement here). This development comes nearly 14 months after FDA issued both guidance documents in draft form, which also coincided with FDA’s announcement of a new comprehensive regenerative medicine policy framework intended to spur innovation and efficient access to new regenerative medicine products.
FDA Commissioner Scott Gottlieb remarked that the finalization of regenerative therapy guidance ...
Gummies, brownies, sodas, cookies . . . consumer appetite for food and dietary supplement products containing cannabidiol (“CBD”) has grown over the last few years as states have moved to legalize cannabis for medical or limited recreational use. With the passage of the 2018 Farm Bill on December 20, 2018, which legalized the cultivation of hemp for certain purposes, the “edibles” industry appeared poised for further expansion.
However, recent developments at both the federal and state level may be putting the “edibles” industry on a diet. In the past week, bans on the ...
For the first time since 2008, the Advanced Medical Technology Association (“AdvaMed”) has updated its “Code of Ethics on Interactions with Health Care Professionals.” These updates were announced on January 9, 2019 and will become effective on January 1, 2020.
AdvaMed’s goal in updating the Code was to address the evolving nature of interactions between the medical device industry and health care professionals (“HCPs”), bring existing examples up-to-date, and enhance user-friendliness. Topics that were previously covered in multiple areas of the Code are now ...
Data is king! A robust privacy, security and data governance approach to data management can position an organization to avoid pitfalls and maximize value from its data strategy. In fact, some of the largest market cap firms have successfully harnessed the power of data for quite some time. To illustrate this point, the Economist boldly published an article entitled “The world’s most valuable resource is no longer oil, but data.” This makes complete sense when research shows that 90% of all data today was created in the last two years, which translates to approximately 2.5 ...
On December 11, 2018, the Food and Drug Administrative (“FDA”) issued a draft guidance for comment entitled, “Biomarker Qualification: Evidentiary Framework” (the “Guidance”). The Guidance provides insight regarding standards for biomarker qualification under the 21st Century Cures Act (“Cures Act”).
FDA defines the term “biomarker” as a “characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.” There are various ...
On October 18, 2018, the FDA published Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. This guidance outlined recommendations for cybersecurity device design and labeling as well as important documents that should be included in premarket approval submissions. This guidance comes at a critical time as the healthcare industry is a prime target for hackers. On January 22, 2019, the U.S. Department of Homeland Security Industrial Control System Cyber Emergency Team (US-CERT) issued another advisory regarding medical device ...
The federal government entered into a partial shutdown at midnight on Saturday, December 22, 2018. The implications of the ongoing shutdown are far-reaching, but its impact on the Food and Drug Administration (“FDA”) is of particular concern to members of FDA-regulated industries and those with a role in ensuring the public health. Thousands of FDA employees considered non-essential were furloughed and, consequently, routine regulatory and compliance activities at FDA were put on hold. On his Twitter account (@SGottliebFDA), Scott Gottlieb, M.D., Commissioner of the FDA ...
On December 7, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule (“Proposed Rule”) that, if finalized, would clarify the de novo classification process for medical devices, including (1) the format and contents of a de novo request and (2) the criteria for accepting or denying a de novo request. FDA intends to “enhance regulatory clarity and predictability... [and] provide a regulatory framework that sets clear standards, expectations and processes for de novo classification” through this proposed rulemaking.
FDA regulates medical ...
On December 18, 2018 the Food and Drug Administration (“FDA”) finalized guidance on its existing Breakthrough Device Program and announced plans for advancement of the Safer Technologies Program (“STeP”). In the announcement, FDA Commissioner Scott Gottlieb emphasized the FDA’s efforts to promote innovation in medical devices that advance patient safety. This new medical device guidance could signal a year of opportunity for innovative medical device manufacturers that seek to advance patient safety.
Breakthrough Device Program
The Breakthrough Device ...
On November 26, 2018, the U.S. Food and Drug Administration (“FDA”) announced the process for clearing most medical devices for marketing is being updated to incorporate changes the FDA laid out in an April draft guidance. For over forty years, most medical devices have entered the United States market through the 510(k) clearance process. The 510(k) process offers an expedited approval process available only for products that are substantially equivalent to products already on the market (known as predicate devices). The FDA is considering no longer allowing sponsors to ...
On November 19, 2018, the FDA submitted a proposal to the White House Office of Management and Budget (OMB) to approve a review that will assess current communication practices between FDA review staff and Investigational New Drug (IND) sponsors. The FDA has contracted with Eastern Research Group (ERG) to determine whether the current mode of communication between these parties needs to be adapted moving forward. Depending on the results of this review, communication practices and requirements could be altered, which might have an effect on the IND application process. Possible ...
Following up on its July 2017 guidance on the same topic (discussed in a previous blog post), FDA issued a proposed rule on November 15, 2018 to amend Agency regulations to allow Institutional Review Boards (“IRBs”) to waive or alter certain informed consent elements (or in some cases, waive the informed consent requirement altogether) for FDA-regulated, minimal risk clinical investigations (“Proposed Rule”).
What Clinical Investigations are Affected?
Importantly, the only clinical investigations affected by the Proposed Rule are those that are FDA-regulated and ...
On November 1, 2018, the Office of the Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) published an audit report finding that the U.S. Food and Drug Administration’s (“FDA”) policies and procedures were “deficient for addressing medical device cybersecurity compromises.” (A copy of OIG’s complete report is available here and Report in Brief is available here.) Specifically, the OIG found that FDA’s policies and procedures were “insufficient for handling postmarket medical device cybersecurity events” and ...
On October 15, 2018, the Centers for Medicare and Medicaid Services (CMS) unveiled its proposed rule requiring direct-to-consumer television advertisements for prescription drug and biological products to contain the list price (defined as the Wholesale Acquisition Cost) if the product is reimbursable by Medicare or Medicaid. Medical devices are not included in the proposed rule, although CMS seeks comment on how advertised drugs should be treated if used in combination with a non-advertised device. If finalized, the requirement will be sweeping and only purports to exclude ...
On October 2, 2018, FDA Commissioner Scott Gottlieb released a statement announcing new agency actions to further deter “gaming” of the generic drug approval process through the use of citizen petitions. Among these actions, the most significant was the issuance of a revised draft guidance on citizen petitions subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), published on the same day. The stated goal of this revision was to create a more efficient approach to 505(q) petitions and to allow the Agency to focus reviewer resources on scientific ...
The FDA issued a new Draft Guidance today to ensure medical devices - an increasing potential target for hackers - are better protected from unauthorized digital access.
According to the FDA’s draft guidance issued today, “Cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the US and globally. Such cyberattacks and exploits can delay diagnoses and/or treatment and may lead to patient harm.”
Under the proposed draft guidance manufacturers will be required to ...
On September 28, 2018, the U.S. Food and Drug Administration (FDA) released two draft guidances for industry. The purpose, according to FDA Commissioner Scott Gottlieb, M.D., is to modernize the approach to clinical trial design in efforts to (1) make clinical trials more efficient while maintaining patient safety and (2) increase the amount of information concerning product safety and benefits. The two draft guidances are entitled: “Master Protocols – Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics” and “Adaptive ...
Two draft guidances issued together late last month seek to increase both clinical trial efficiency and the amount of information that is available about a drug’s safety and benefits. The two draft guidances address, respectively, adaptive designs and master protocols. This blog post discusses FDA’s recommendations for adaptive designs; master protocols will be addressed in a subsequent blog post.
An adaptive design is a “clinical trial design that allows for prospectively planned modifications to one or more aspects of the design based on the accumulating data from ...
On September 20, 2018, the U.S. Food and Drug Administration (“FDA”) released draft guidance “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank” (“Guidance”). The purpose of this Guidance is to explain FDA’s protocol in (1) determining how the centers will identify whether responsible parties failed to comply with submission and certification requirements to the ClinicalTrials.gov or submitted false or misleading documents to the data banks and (2) deciding when, why, and what civil monetary penalties will be assessed against the ...
Eighty years ago today, President Roosevelt signed the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). In recognition of this anniversary, EBG reviews how the FD&C Act came to be, how it has evolved, and how the Food and Drug Administration (“FDA”) is enforcing its authority under the FD&C Act to address the demands of rapidly evolving technology.
I’m Just a Bill
The creation of the FD&C Act stems from a sober event in American History. In 1937, a Tennessee drug company marketed elixir sulfanilamide for use in children as a new sulfa drug. The diethylene ...
Two cases decided over the last three months have added California and Massachusetts to the list of minority states that hold brand name manufacturers of drugs (“Brand Manufacturers”) liable under state “failure to warn” laws when sued by patients that exclusively used a generic version of the Brand Manufacturer’s drug. These cases follow the US Supreme Court decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (“PLIVA”), which held that generic drug manufacturers cannot be held liable for failure to update the safety label of a drug or biologic in ...
New rules issued on November 7, 2017 by FDA will make it easier for companies to offer certain types of genetic tests directly-to-consumers (DTC), without a health-care provider intermediary.
The first rule exempts "autosomal recessive carrier screening gene mutation detection systems" that are offered DTC from FDA premarket review. FDA first proposed this exemption in 2015, on the same date as the agency issued a final order classifying these types of tests as Class II medical devices, in response to a request from 23andMe. The 2015 final rule specified the conditions under which ...
The passage of the 21st Century Cures Act ("Cures Act") and revisions to the Common Rule (45 CFR Part 46) ("Common Rule") in the last year mandated significant changes to informed consent laws. As a result of these changes, sponsors of research ("Sponsors"), institutions conducting research ("Institutions"), and the institutional review boards ("IRBs") approving research will need to review policies and practices involving informed consent. As explained below, a recently published FDA guidance document makes a first step toward implementing some of these changes by ...
At the end of July, FDA released a tangible plan for promoting innovation in the development of digital health products. In this Digital Health Innovation Action Plan, FDA acknowledges that digital health technologies are critically important in advancing health care, and that traditional FDA pathways to market are not well suited for all of these technologies. Over the last few years, FDA has taken a deregulatory approach with respect to low risk digital health products and has issued guidance regarding its enforcement discretion approach to wellness products, medical device ...
On May 9, 2017, Scott Gottlieb, M.D. was confirmed by the Senate as the new Commissioner of the Food and Drug Administration ("FDA"). As Commissioner, he will be immediately responsible for shaping FDA policy on a number of current issues, including addressing and implementing several mandates stemming from the 21st Century Cures Act, ("Cures Act"), which was signed into law on December 13, 2016 with tremendous bipartisan support. The Cures Act contains over 200 sections that create new obligations for FDA; however, most pressing for Commissioner Gottlieb are three requirements ...
On January 19, 2017, the United States Food and Drug Administration ("FDA") unveiled a new drug designation process for regenerative advanced therapies, an important first step toward implementation of the regenerative medicine provisions of the 21st Century Cures Act. Products for which a designation as a regenerative advanced therapy ("RAT") is obtained are eligible for accelerated approval under the 21st Century Cures Act, which was signed into law by former President Obama on December 13, 2016 with sweeping bipartisan support.
The accelerated approval provisions for RATs ...
Congress is currently considering two bills that would dramatically alter the ways in which all federal agencies develop and publish rules. If enacted, both would create significant new obligations for agencies such as CMS and the FDA, expand the scope of judicial review of rules, and would increase the potential for political influence over the rulemaking process. Both bills passed the House on party-line votes, and are under consideration by the Senate.
The first bill, H.R. 5, would overhaul multiple phases of the federal rulemaking process. These proposed changes would make the ...
Early January has seen the release by FDA of a flurry of information on drug and device manufacturer communications, largely reaffirming FDA's long-held approach to restricting manufacturer communications regarding off-label uses of approved drugs and medical devices. The most significant positive development arising from these documents is the Agency's concession on proactive pre-approval communications with payors about investigational drugs and devices, allowing certain information to be provided to payors prior to a product's approval. FDA's guidance documents ...
Recent federal and state legislative efforts signal an increased focus on a significant and largely underappreciated public health threat – antimicrobial resistance (i.e., when a microorganism (such as a bacteria or virus) is able to resist the effects of medications such as antibiotics and antivirals, causing such medications to be ineffective). The results of a 2014 study underscore the magnitude of the threat of so-called "superbugs," estimating that the number of deaths worldwide attributable to antimicrobial resistance will reach 10 million by 2050. By comparison, the ...
On November 16, the City of Chicago passed an ordinance that will require pharmaceutical sales representatives to become licensed in order to promote prescription drugs to health care providers within city limits. The ordinance was passed unanimously, despite ardent objections from pharmaceutical manufacturers and industry organizations. While Mayor Rahm Emanuel states that the new licensing requirement is part of a larger series of efforts by the city to combat heroin and opioid addiction, industry representatives characterize the license as a harmful tax increase that ...
On October 24, 2016 the Food and Drug Administration ("FDA") in conjunction with the Centers for Medicare & Medicaid Services ("CMS") announced their intention to extend the Parallel Review pilot program indefinitely. The Parallel Review process is intended to provide timely feedback on clinical data requirements from FDA and CMS, and minimize the time required for receiving Medicare coverage nationally. Sounds good. So, why have so few manufacturers taken advantage of the program to date?
Despite its admirable goals, the current Parallel Review Process is too limited in scope ...
Health care providers, life sciences companies and other entities subject to regulation by the Food and Drug Administration ("FDA") or the Centers for Medicare & Medicaid Services ("CMS") should be aware that the U.S. Department of Health and Human Services ("HHS") is increasing the maximum civil monetary penalty amounts that may be assessed by the agency.
The new maximum adjusted penalty amounts may have a significant impact on entities that violate or fail to meet mandatory reporting requirements set by FDA or CMS. Of the 299 enumerated increased fines, 137 fines (45.8%) have ...
On August 31, 2016, FDA issued a notification of public hearing and request for comments on manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016, and individuals wishing to present information at the hearing must register by October 19, 2016. The deadline for written comments is January 9, 2017.
In the notice, FDA posed a series of questions on which it is seeking input from a broad group of stakeholders, including manufacturers, health care providers, patient advocates, payors, academics ...
The Food and Drug Administration (FDA) issued a draft guidance (Draft Guidance) on July 11, 2016 that allows some generic drug manufacturers holding an Abbreviated New Drug Application (ANDA) to update the label of the drug they manufacture with new safety information. The Draft Guidance provides new clarifications and recommendations to generic drug manufacturers seeking to update a generic label after withdrawal by the name brand manufacturer of the reference listed drug (RLD) (a "Withdrawn RLD"). The Draft Guidance explains how a generic manufacturer may submit an updated ...
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