FDA Regulatory

One of the new Food and Drug Omnibus Reform Act requirements is that developers of “cyber devices” design and implement plans to “monitor, identify and address” cybersecurity vulnerabilities of marketed devices and to submit those plans to FDA as part of every new product application for a cyber device. The amended law defines a “cyber device” as one that includes software, connects to the internet, and contains any technological features that could be vulnerable to cybersecurity threats.

On March 9, 2023, the Food and Drug Administration (FDA) published a final rule to update the Mammography Quality Standards Act (MQSA) to reflect advances in mammography technology and, among other requirements, standardize aspects of mammography reports patients receive. Most notably, the final rule requires informing patients about whether they have "dense" or "not dense" breast tissue and establishes a new mandatory timeframe for facilities to send those reports to the referring health care provider (i.e., within 30 days). The final rule, which takes effect on September 10, 2024, modernizes the MQSA by addressing changes in mammography technology and making improvements that enhance enforcement of quality standards as well as the way mammography results are provided to patients and health care providers.

The information age in which we live is reaching a new milestone with the development and ready access to conversational artificial intelligence based on advanced transformer algorithms, or AI chatbots, including their upcoming integration into multiple Internet search engines. This development creates exciting opportunities and potentially terrifying risks in the health care space. Inevitably, people will ask AI chatbot-enabled search engines for information on diseases, conditions, medicines, or medical devices and use the response in some way to make certain medical decisions. But what happens when the AI chatbot’s response is inaccurate or even provides advice that may lead to harm if the user follows it? Can AI chatbots be regulated by the U.S. Food and Drug Administration (FDA)? What are the liability implications if a user is harmed? We provide some initial thoughts on such legal issues in this post.

There has been a lot of discussion of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which was enacted on December 29, 2022 as part of the larger Consolidated Appropriations Act for 2023, but we should also take a moment to review last year’s actions and policy updates on digital health from the Food and Drug Administration (FDA). The year 2022 marked the conclusion of the five-year Software Precertification Pilot Program and the release of the final Clinical Decision Support Software guidance, among other things (both described below); however, major digital health policy updates and announcements were few and far between. In this post, we summarize the agency’s key actions in the digital health space in 2022.

On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act for 2023, colloquially referred to as the omnibus funding bill, that includes a similarly expansive and diverse piece of legislation called the Food and Drug Omnibus Reform Act (FDORA). This latest addition to the rich history of amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes a variety of new and important changes to the laws governing therapeutic products and medical devices, clinical trials, and (in a much rarer occurrence) cosmetics and other personal care products. Many of the statutory changes had been requested by the Food and Drug Administration (FDA), whether formally via budget requests or more informally via its leadership. The agency also received an increase of $226 million (or 6.5%) in its congressional appropriation for fiscal year 2023 as compared to its funding level for fiscal year 2022, suggesting continued bipartisan support for its public health mission.  

As the 2022 calendar year ended, the Consolidated Appropriations Act, 2023 was signed into law by President Biden. The massive piece of legislation included the Modernization of Cosmetics Regulation Act of 2022 (MOCRA), comprising a long-awaited update to the nation’s cosmetic laws. MOCRA amends Chapter VI of the Federal Food, Drug, and Cosmetic Act (FD&C Act). As noted by one of the bill’s co-sponsors, Senator Dianne Feinstein, after its passage, it finally brings the federal government’s “oversight tools” for cosmetics and personal care products “into the 21^st century.”

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.