FDA Regulatory

There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary roundup for our readers! 

The Food and Drug Administration (FDA) issued a guidance on development and emergency use authorization of diagnostic and serological tests for the monkeypox virus following the Secretary of the Department of Health and Human Service’s declaration of a public health emergency under Section 564 of the Food, Drug and Cosmetic Act on August 9, 2022. Subsequently, the Secretary declared on September 7 that in vitro diagnostics for monkeypox were needed to respond to the public health emergency, and the FDA released its guidance on the same day. The monkeypox test guidance describes the agency’s general expectations and approach for test development and validation, as well as the EUA request process.

On September 15, 2022, the Department of Justice (DOJ) announced a $7.9 million settlement with generic manufacturer Akorn Operating Company LLC (Akorn) to resolve allegations that Akorn caused the submission of over-the-counter (OTC) drugs to Medicare Part D in violation of the False Claims Act (FCA).  Because Medicare Part D only covers prescription drugs, the pertinent drugs were not eligible for Medicare reimbursement. The conduct at issue under this settlement is a relatively novel basis for FCA liability, but we may see similar government enforcement actions in the future as the federal government actively encourages drug manufacturers to “switch” prescription drugs to OTC status in order to enhance their accessibility and reduce costs. This blog post provides an overview and analysis of the settlement. 

The head of the Food and Drug Administration (FDA), Dr. Robert Califf, announced on August 30, 2022 that, in addition to an extensive review of opioid regulations, the agency is launching a framework aimed at preventing overdose-related deaths.  Commissioner Califf previously committed to leading a review of opioid regulations during his December 2021 confirmation hearing, in response to repeated questions from Senators regarding FDA’s response to the ongoing opioid epidemic and broader public criticism of the agency’s historical actions in the space.  The commitment to regulatory review also follows criticism FDA has received over the years for approving OxyContin in 1995 and many other addictive opioid drugs since then without requiring more thorough warning labels and other protections that could help combat misuse and over-prescribing.

Receiving a warning letter from the U.S. Food and Drug Administration (FDA) means that the agency has identified what it calls “violations of regulatory significance” and that you (as the recipient) need to take corrective actions or risk inviting some actual enforcement under the Food, Drug, and Cosmetic Act (FD&C Act), which could include injunctions, seizures, and criminal penalties. This post highlights what an FDA warning letter means for Amazon.com as well as potential implications for the retail giant.

Unintended downstream consequences are likely to abound in the wake of the June 24, 2022 Dobbs decision that overruled Roe v. Wade, as Mintz attorneys have addressed in other contexts. Those looking ahead have raised concerns about women’s continued access to the wide array of birth control options that have been approved for use in the United States by the Food and Drug Administration (FDA). This post provides a brief historical background on how OTC birth control pills have been regulated under the Federal Food, Drug, and Cosmetic Act and reviews the FDA's Additional Conditions for Nonprescription Use (ACNU) Proposed Rule.

The U.S. Food and Drug Administration (FDA) will schedule a public meeting of the Medical Devices Advisory Committee later this year to discuss study results, real-world data, and other evidence concerning the accuracy and performance of pulse oximeters. The planned meeting is consistent with the agency’s recent efforts to evaluate the need for and options to address transparency and diversity in the design and development of artificial intelligence/machine learning (AI/ML) based software devices (see our post covering FDA’s Transparency of AI/ML Enabled Medical Devices Workshop) and in clinical trial design. It is unclear whether or how the outcome of the planned meeting on pulse oximeters will affect prescription and over-the-counter (OTC) pulse oximeters currently on the market, but it is possible that the meeting could lead FDA to impose new testing or labeling requirements for pulse oximeters, and perhaps even other devices that use light-based sensors to evaluate certain biometrics.

Anyone who has spent any time around health care policymaking circles in Washington, D.C. has heard about the intense five-year cycle Congress goes through in order to reauthorize the biggest user fee programs at the Food and Drug Administration (FDA). Mintz previously published this wonderful explanation of the process complete with an estimated timeline for how this year’s reauthorization was likely to go. As a reminder, the current authorization for FDA’s various human product user fee programs – with the exception of the over-the-counter drug program that was freshly created in 2020 – will expire on September 30, 2022 with the end of the federal government’s fiscal year, unless they are renewed by Congress before that time.

On May 4, 2022, the U.S. Food and Drug Administration (FDA) for the first time issued warning letters related to products containing delta-8 tetrahydrocannabinol (delta-8 THC).  FDA has previously sent warning letters to other companies illegally selling unapproved and misbranded cannabidiol, or CBD, products that claimed to treat illness in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as we have discussed in prior posts (one example here).  In a separate recent slew of CBD-related actions, it issued warning letters jointly with the Federal Trade Commission (FTC) to seven companies for selling CBD products with claims that they will treat or prevent COVID-19. This blog post will define delta-8 THC and analyze the FDA's warning letters. 

As the COVID-19 public health emergency drags into its third year, we continue to keep track of efforts by the Food and Drug Administration (FDA) to combat fraud in the form of fake cures, counterfeit diagnostic tests, and other products claiming to prevent, treat, or detect infection by SARS-CoV-2 that are marketed without required FDA authorization. Our previous posts provided updates on joint and separate efforts by FDA and the U.S. Federal Trade Commission (FTC) throughout the pandemic to detect and eliminate these illegal products. In this post, we focus on FDA’s recent enforcement activities concerning COVID-19 diagnostic tests and the agency’s increasingly aggressive pursuit of entities offering counterfeit or unauthorized tests.

It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12 months and consider what the agency is likely to focus on going forward. This year, however, we’re taking a different approach and will be providing more of a birds-eye view of our favorite federal agency as it stands as of the end of 2021. Because there is just too much going on at the administrative, enforcement, and legislative levels to get into the details of everything in one fell swoop. So make sure you’re signed up for Mintz Health Law Viewpoints to receive updates throughout the year on issues as they develop.

On December 22, 2021, FDA took another step in rolling back enforcement policies implemented in response to the COVID-19 pandemic by publishing guidance documents describing the regulatory requirements for devices that were authorized under the emergency use authorization process and those under temporary FDA policies implementing specific enforcement discretion during the pandemic once the Public Health Emergency for COVID-19 ends. The Transition Plan Guidances will help device manufacturers prepare for the end of the PHE and continue to commercialize devices necessary for the long-term response to COVID-19.

For over a year now, there has been speculation about how the Biden Administration would handle the chronically vexing regulatory issues associated with laboratory-developed tests (LDTs). On November 15, 2021 we finally got our answer when the August 2020 policy put in place by the Trump Administration was officially withdrawn. The Food and Drug Administration (FDA) also released corresponding updates to various guidelines related to the testing response to the ongoing public health emergency. Before summarizing all of these critically important developments, we’ll provide some quick history of what has been going on with LDTs since the pandemic began.

Over the course of 2020, the Food and Drug Administration (FDA) released numerous guidance documents covering diverse areas and aimed at increasing the availability of various medical products to prevent, treat, and diagnose COVID-19. Some of our prior blog posts on those pandemic response activities implemented by FDA can be found here and here. In all of those actions, FDA made clear that the agency’s enforcement discretion policy was temporary, or that an emergency use authorization (EUA) was being granted pursuant to statutory criteria that include a requirement that there be “no adequate, approved, and available alternative to the product,” which by definition renders the EUA temporary, as well. Accordingly, several EUAs granted to diagnostic tests, therapeutic products, and medical devices have been revoked based on a determination that all of the criteria necessary to support emergency authorization under the statute can no longer be met. And although the public health emergency is not over even as 2021 comes to a close, FDA has kept its promise to continually reassess circumstances and needs on the ground in the United States and to modify policies and emergency authorizations as necessary.

In the weeks leading up to FDA’s October 14, 2021 Transparency of AI/ML Enabled Medical Devices Workshop (Workshop) we took a brief look at the history of FDA’s regulation of medical device software and the agency’s more recent efforts in regulating digital health. In this post, we will provide an overview of the topics discussed at the Workshop and our impressions of the agency’s likely next steps.

By now, businesses operating in the over-the-counter (OTC) drug product space should all be familiar with the changes made by Congress to the regulatory system with the final OTC Monograph reform bill, which was included as part of the Coronavirus Aid, Relief, and Economic Security Act that was signed on March 27, 2020 (see our prior posts here and here).

As we’ve reported previously, at the end of 2020, the Office of Non-Prescription Drugs (ONP) of the Food and Drug Administration (FDA), launched a webpage for its brand new user Over-The-Counter Monograph User Fee Program (OMUFA) – available here – published programmatic fee rates for Fiscal 2021 (which ended on September 30, 2021), and subsequently posted a public arrears list of facilities that did not make their FY2021 facility payments as was required to be done by May 10, 2021. Drugs produced by those in-arrears facilities are considered misbranded under the law.

In our last post, we took a brief look back through history at FDA’s approach to regulating medical device software and found that there is little distinction from the agency’s approach to hardware devices. Recently, however, FDA has announced several digital health initiatives aimed at improving the agency’s resources and policies governing software and data systems (including its own internal data systems) and changing the way the agency handles pre-market reviews of and compliance activities for software as a medical device (SaMD) and SaMD manufacturers. In this post, we will review FDA’s digital health improvement highlights from the past few years and take a quick look at the agenda for the transparency of AI/ML-enabled medical devices workshop scheduled for October 14, 2021.

In anticipation of FDA’s virtual public workshop on transparency of artificial intelligence/machine learning (AI/ML)-enabled medical devices scheduled for October 14, 2021, we will be posting a series detailing the history behind FDA’s regulation of software and then reporting our impressions of FDA’s presentations and statements from various attending stakeholders following meeting. In this part, we briefly summarize FDA’s traditional approach to regulating software and how software development quickly revealed the limitations of the original regulatory framework established in the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Agencies of the federal government with a consumer protection mission have always tended to work closely together and to share information, but the COVID-19 pandemic has made those cooperative efforts even more visible to the general public. We blogged in 2020 about the increasing use of warning letters jointly issued by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) Division of Advertising Practices in the apparently never-ending fight against fraudulent COVID-19 products (see prior post here). While coordinated FDA and FTC enforcement activities specific to the ongoing public health emergency continue at a brisk pace – as of September 9, 2021, FDA has issued more than 200 warning letters to companies claiming that a product is an effective cure, treatment, or preventative for COVID and the FTC has issued more than 400 pertaining to unsubstantiated health claims for COVID-related products, with many of those being signed by both agencies – these powerhouse regulators also appear to have become more comfortable with announcing joint actions in non-COVID contexts. This trend makes it even more important for manufacturers and marketers of consumer-facing products to be fully aware and compliant with all of their legal and regulatory obligations.

It’s finally here – the Drug Pricing Plan that President Biden ordered the Department of Health and Human Services (HHS) to produce by the end of August (the “Plan”) was released publicly by the Administration on September 9, 2021. The Plan makes it clear that the Biden Administration supports aggressive action to address rising drug prices, including controversial actions such as allowing HHS to negotiate the cost of Medicare Part B and D drugs. The Plan also outlines a set of administrative actions that HHS and its operating agencies can take, without the need for intervention by Congress. A notable gap in the Plan, however, is the Administration’s potential approach to manufacturer rebates and the Rebate Rule.