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.

Continue Reading Unpacking Averages: Assessing FDA’s Performance Categorizing New Diagnostic Tests Under CLIA

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.

Continue Reading Unpacking Averages: Connecting Published Clinical Trials with FDA Drug Approvals

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?

Continue Reading Unpacking Averages: Assessing the Racial Composition of Drug Clinical Trial Subjects

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.
Continue Reading CMS “Splits the Baby” on Aduhelm—Medicare Coverage but Only with Evidence Development for Now

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.

Continue Reading Unpacking Averages: Likelihood of FDA Medical Device Inspections

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.

Continue Reading Unpacking Averages: Popular Ways to Combine Device Functionality

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

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

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.”[1] 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.[2] 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.”[3]

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.[4] DOJ also plans to collect certain information from qui tam relators regarding third-party litigation funders during relator interviews.[5] 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.[6]

  1. 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.”[7] 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.[8] 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.”[9]

DOJ litigators have been advised to inform relators of the possibility of dismissal.[10] 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.”[11]

  1. 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,[12] 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.[13] 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.[14] 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. [15] 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.[16] 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.[17] While the Litigation Funding Transparency Act of 2019 has remained inactive since its introduction in February 2019 by Senator Grassley[18] 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,[19] 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.

Continue Reading False Claims Act Enforcement During the COVID-19 Pandemic and Beyond