Health Law Advisor

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.]

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.

Important guidance regarding COVID-19 testing in the workplace was recently issued by the Centers for Medicare & Medicaid Services (“CMS”) in the form of Frequently Asked Questions regarding Over the Counter (“OTC”) Home Testing and CLIA Applicability.

CMS regulates clinical laboratory testing pursuant to the federal Clinical Laboratory Improvement Act (“CLIA”). Generally, a laboratory or clinical setting (such as a physician’s office) must obtain CLIA certification to perform laboratory testing. Some OTC tests, however, are approved by the Food and Drug Administration (“FDA”) for home use and the new FAQs address the use of OTC home tests in the workplace.

On September 15, 2021, CMS published a proposed rule that would repeal a final rule that created an expedited pathway for Medicare coverage of breakthrough devices and established formal criteria for applying the “reasonable and necessary” standard for coverage in Section 1862(a)(1)(A) of the Social Security Act, which has been the basic standard for coverage since the inception of the Medicare program.[1]  CMS has set a short period for comments, and interested parties must submit comments by October 15, 2021.

The new proposed rule reflects a significant policy change.  Where the initial rule focused on expanding access to new innovations, the current approach focuses more on Medicare program goals and outcomes data.

On June 12, 2021, a federal District Court in Texas soundly rejected an attempt by Houston medical workers to challenge the legality of their employer’s decision to require that all employees receive a COVID-19 vaccine. In the lawsuit, Bridges, et al. v. Houston Methodist Hospital et al., 117 hospital workers sued for an injunction to block the hospital’s mandatory vaccination policy as well as the termination of any employee unwilling to comply with the employer’s mandate that all employees be vaccinated against COVID-19. More specifically, the employees asserted that the ...

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 ...

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 ...

The U.S. Department of Justice reached a January 31, 2019 settlement of an American with Disabilities Act ("ADA") Title III complaint against health care provider Selma Medical Associates relating to provision of medical services to an individual with opioid use disorder ("OUD").  The settlement is notable for health care providers and employers as it makes clear that DOJ considers OUD as a disability under the ADA thereby triggering the full panoply of ADA rights for those with OUD.

The DOJ complaint was premised on the alleged refusal of Selma Medical to schedule a new patient family ...

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 21^st 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.[1]

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 ...

Our colleague Stuart M. Gerson at Epstein Becker Green has a post on the Health Law Advisor blog that will be of interest to our readers in the health care industry: “NIST Seeks Comments on Cybersecurity Standards For Patient Imaging Devices.”

Following is an excerpt:

The National Institute of Standards and Technology (“NIST) has announced that it will be seeking industry input on developing “use cases” for its framework of cybersecurity standards related to patient imaging devices. NIST, a component of the Department of Commerce, is the agency assigned to the ...

The National Institute of Standards and Technology (“NIST) has announced that it will be seeking industry input on developing “use cases” for its framework of cybersecurity standards related to patient imaging devices. NIST, a component of the Department of Commerce, is the agency assigned to the development and promulgation of policies, guidelines and regulations dealing with cybersecurity standards and best practices.  NIST claims that its cybersecurity program promotes innovation and competitiveness by advancing measurement science, standards, and related ...

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 ...

Where does the line fall between good faith and criminal intent? That was the question that a Massachusetts federal jury faced in July as it deliberated criminal charges against William Facteau and Patrick Fabian, ex-Acclarent executives, who were indicted on multiple charges of fraud and misbranding a medical device. Acclarent's device, the Relieva Stratus Microflow Spacer ("Stratus"), was cleared by the FDA for use as a spacer to maintain an opening in the sinus. Although the FDA expressly rejected Acclarant's request to expand the indicated use of the device to include delivery ...

Despite popular opinion, lawyers and judges are human and sometimes the facts of a case make it near impossible for judges to play the role of the modest umpire calling balls and strikes described by Chief Justice Roberts in his confirmation hearing.  Sometimes, bad facts make bad law because the plaintiff is so sympathetic that the just ruling may not be the "right" one.  Fachon v. U.S. Food and Drug Administration et al., appears to be the epitome of this.

Earlier this year, a 20-year old man, Eugene Neil Fachon, was diagnosed with Diffuse Intrinsic Pontine Glioma ("DIPG") a form of brain ...

On May 17, 2016, FDA issued Draft Guidance for Industry on Use of Electronic Health Record Data in Clinical Investigations ("Draft Guidance").  This Draft Guidance builds on prior FDA guidance on Computerized Systems Used in Clinical Investigations and Electronic Source Data in Clinical Investigations, and provides information on FDA's expectations for the use of Electronic Health Record ("EHR") data to clinical investigators, research institutions and sponsors of clinical research on drugs, biologics, medical devices and combination products conducted under an ...

On December 23, 2015, the Food and Drug Administration's (FDA) released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. This was a positive step towards helping pharmaceutical companies invest and implement emerging technologies that improve overall drug quality.

Pharmaceutical companies have spent millions of dollars issuing recalls for products because of a variety of quality issues caused by outdated manufacturing technologies. These issues have caused significant delays in providing ...

FDA has recently partnered with PatientsLikeMe, an online patient networking forum, to leverage patient-reported information to bolster its drug safety monitoring efforts. PatientsLikeMe, with its 350,000 members representing over 2,500 health conditions, has collected more than 110,000 adverse event reports on 1,000 different drugs. This partnership, which is in the form of a research collaboration agreement, will provide FDA with access to "real-world" data about patients' drug and disease experiences (the information provided to FDA is anonymous; so it does not ...

Our colleagues James A. Boiani and John S. Linehan at Epstein Becker Green wrote an advisory on the U.S. Food and Drug Administration's ("FDA") introduction of new plans to constrain animal drug compounding with the release of its Draft Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Drug Substances. In this advisory, the parameters of the Draft Guidance are outlined, which suggests that a dramatic shift in the FDA's enforcement approach may be underway and provides insight into the FDA's enforcement priorities and its interpretation of the applicable ...

While FDA made a push last fall to explore the technical challenges associated with 3-D printed devices (holding a public workshop in October 2014), the Agency's planned guidance on the topic fell to the "B-list" in FDA's 2015 medical device guidance agenda. According to the agenda, the Agency will issue a draft guidance document on 3-D printing as "guidance-development resources permit." In light of the regulatory uncertainty facing 3-D printing stakeholders, this may seem like unwelcome news – but is it?

Recent comments from Agency officials suggest that immediate guidance is ...

One of the most discussed aspects of healthcare has to be how to balance cost, quality and access.  This is especially true when it comes to the pharmaceutical industry, particularly with the rapid growth of and increased focus on highly effective, but highly expensive, specialty drugs.  Discussions about these costs are no longer isolated to negotiations between pharmaceutical companies, PBMs and insurers; instead it appears that price and cost are on FDA's radar. 

For example, the Oncologic Drugs Advisory Committee ("ODAC") hearing, earlier this month, was not only historic ...

WHEN: Thursday, February 26, 2015

TIME: 12:00pm – 1:30pm EST

To register for this webinar, please click here.

Please join us for a complimentary webinar addressing wireless health regulatory issues. This session will discuss recent trends in health technology regulation; including Food and Drug Administration (FDA) developments, Federal Communications Commission (FCC) requirements, wireless technology and communication issues, mobile applications, decision support and other Health IT challenges, and privacy and cyber security considerations.

This session is ...

When FDA published its draft guidance Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices in June 2014, I, like many others with an interest in pharmaceutical and medical device promotion, believed that the issue of social media promotion of drugs and medical devices was largely settled. Even with the limited concessions offered by FDA to reduce the traditional risk disclosure requirements, absent a substantial shift in FDA's position, Twitter was not going to be a medium that ...

FDA published the long awaited draft guidance on wellness products last Friday. The guidance is a positive step forward for industry in that it proposes that certain general wellness products will not be subject to FDA regulation.

The draft guidance clarifies that FDA does not intend to enforce its regulations against products that are "low risk" and are intended to:

1. Maintain or encourage health without reference to a disease or condition (e.g. weight, fitness, stress) or
2. Help users live well with or reduce risks of chronic conditions, where it is well accepted that a healthy ...

On December 18, 2014, FDA released proposed regulations that would make prescribing information for drugs and biologics available online and prohibit distribution of paper copies as part of product packaging.  FDA's stated goal is to make prescribing information widely and easily accessible to healthcare providers and consumers alike, but some consumer and provider groups are criticizing the proposed rules because they may limit access to prescribing information in communities where the Internet is not readily available.  The proposed rules also go against Senate ...

Last week, FDA launched Drug Trials Snapshot, a pilot program intended to provide consumers with information about the sex, age, race and ethnicity of clinical participants for six drugs approved in May and June 2014.  This pilot is intended to solicit feedback on the content, format and usefulness of the information provided in advance of an expansion of the program to include all new molecular entities subject to an approved NDA beginning in 2015.

The Drug Trials Snapshot website was developed by FDA in response to the requirements in Section 907 of FDASIA that FDA: 1) report to ...

On November 13, 2014, the Food and Drug Administration ("FDA") announced a proposed study on spousal influence on consumer understanding and responses to direct-to-consumer prescription drug advertisements.  FDA notes that consumers are often thought of as individual targets for prescription drug advertisements, without considering the social contexts in which many treatment decisions are made.  For example, FDA notes that when spouses view an ad together a spouse "may influence their partner by expressing concern about risk and sides effects that might occur ...