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2023: Another Year Chock Full of Challenges for FDA

At the start of 2022, we reflected on what the Food and Drug Administration (FDA) had accomplished during the preceding 12 months and the challenges that could be ahead for the agency during the impending year, especially with 2022 having been a reauthorization cycle for the largest medical product user fee programs relied upon by FDA. Unexpectedly – following a successful legislative cycle that culminated with enactment of the FDA User Fee Reauthorization Act of 2022 on September 30, 2022 – the agency also ended that year with what we called a “holiday present from Congress” when it received a slew of new authorities and mandates through the Food and Drug Omnibus Reform Act (FDORA). FDORA was signed into law by President Biden on December 29, 2022 as part of the Consolidated Appropriations Act for 2023; we touch on the status of some of the major changes ushered in by this important new law below. 

Today, as we are closing out calendar year 2023, perhaps the most notable trend for FDA watchers is how many headwinds cropped up for the agency this past year, even as it achieved significant public health milestones. Some of those agency milestones include approving the first gene-edited therapeutic product for the treatment of sickle cell disease; the first-ever vaccines for respiratory syncytial virus (RSV) aimed at protecting both vulnerable older adults and babies; the first over-the-counter (OTC) birth control pill, and – as the country continues to suffer from an epidemic of drug abuse and overdose deaths – the first OTC naloxone product to reverse opioid overdoses (followed quickly by a second).

Slogging Through Very Tough Issues…

One of the unifying themes in this compilation of FDA’s challenges from 2023 is that they highlight (pretty starkly, in some cases) the limits of the agency’s current delegated authorities, as well as its knowledge about specific products that are in the broad streams of commerce that it is expected to oversee. A few examples include:

  •       January, following several years of a “careful” internal review and analysis of its existing legal authorities, FDA announced it had concluded that food and dietary supplement laws are “not appropriate” for cannabidiol (CBD) and that “a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.” The agency expressed its strong desire to work with Congress on a new pathway, and noted that it would continue to send warning letters in response to clear violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), whether products involved contain CBD or other cannabis-derived ingredients. Accordingly, a comprehensive federal regulatory approach to this new category of consumer products, which have exploded in the marketplace since the 2018 Farm Bill removed hemp from the Controlled Substances Act, will remain elusive so long as FDA’s hands are tied in certain respects without any new express delegations of authority from Congress. But meanwhile, reports of children being poisoned by cannabinoid-containing foods and candies have skyrocketed in recent years.
  •       After waiting – arguably for almost a decade – for Congress to enact legislation creating a new regulatory framework for “in vitro clinical tests” that would apply to both in vitro diagnostic test kits (currently regulated by FDA as medical devices) and laboratory developed tests, or LDTs (currently subject to a long-standing FDA enforcement discretion policy), in late September the agency issued a proposed rule that would end the enforcement discretion policy and make LDTs fully regulated devices. We previously wrote about the proposed rule here and here. The comment period for the proposed rule closed on December 4 and the agency has set a goal to finalize it in April 2024, presumably in order to avoid the risk of congressional “disapproval” of the ultimate final rule. Nonetheless, stakeholder opposition to this critical rulemaking continues and FDA’s complicated challenges resulting from its permissive approach to the LDT industry for the past four decades are not over yet. The Mintz Team will delve into this subject a bit more in our January 2024 post forecasting the upcoming year of FDA activity. 
  •       FDA’s approach – or some would say, lack of an approach – to ensuring the quality and safety of human drugs and other high-risk consumer products (e.g., infant formula) has come under substantial fire from Congress, public health advocates, and other stakeholders as the agency grapples with massive manufacturing failures on the part of the private companies that produce those basic and essential commodities. In particular, all of 2023 was plagued with firm-initiated recalls, import alerts, and warning letters related to OTC eye drops that were – in the worst cases –  contaminated by bacteria and associated with severe consumer injuries like blindness or – in the “best” cases – were not produced in a sanitary facility such that they could have been contaminated or were improperly offered without securing prior FDA marketing approval. The explosion of quality problems with this sterile product class highlights several gaps in the agency’s mandates, including (1) FDA’s lack of authority to order a mandatory recall for drugs found to be violation of the FD&C Act; (2) its inability to track when a new OTC drug manufacturing facility, whether foreign or domestic, begins producing human drugs for the U.S. market or to block such facilities from putting OTC drugs into commerce until some form of FDA inspection of the manufacturing facility can take place. These problems have triggered Congressional investigations into the agency’s work and a mid-December letter from the House Energy and Commerce Committee demanding more information. We expect lawmakers’ oversight on these issues to continue and even potentially ramp up during the upcoming 2024 election year.

…While Trying to Keep Sight of Leapfrogging Technological Innovations

Another theme that can be seen from the agency’s 2023 accomplishments is that it’s working very hard to try to keep pace (or at least not fall too far behind) with technological developments in the medical products space in particular. These efforts can be seen in various FDA guidance documents, public requests for information, and discussion papers intended to spur greater collaboration with regulated industry and the health care community. Some examples of this kind of crucial agency work include: 

  •       FDA’s Center for Devices and Radiological Health announcing in early April through a draft guidance for industry that it would accept predetermined change control plans (PCCPs) to allow manufacturers to bypass prior authorization for modifications to AI/ML-enabled devices after obtaining an initial marketing approval. A PCCP describes the scope of permitted modifications to an AI/ML-enabled device that may be implemented without agency authorization, as long as the manufacturer adheres to the quality review and control requirements specified in the plan.
  •       The publication of two discussion papers in May addressing potential issues associated with the use of AI/ML for the development and manufacture of drug and biological products, including in the areas of drug discovery, nonclinical testing, clinical trials, post-market safety surveillance, and advanced manufacturing. The papers touch on needed controls and areas for regulatory clarification such as human-led risk management, AI/ML system transparency, data model robustness and validation, and quality controls and reliability for data input and output. FDA used the papers to invite stakeholder comments and included specific questions to guide feedback. The agency also held a virtual public workshop titled FDA/PQRI Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing in September to discuss these issues.
  •       FDA’s release in September of a Regulatory Considerations for Prescription Drug Use-Related Software draft guidance, which addresses the rising trend of coupling digital health technologies with medicinal products (whether or not regulated as combination products) and how such technologies may be integrated into drug and biologic product prescribing information or promotional labeling for such products.
  •       The establishment in October of a new Digital Health Advisory Committee, which will be comprised of technical and scientific experts in the technologies being used for health care applications, such as AI/ML and extended reality, as well as areas such as digital health data and cybersecurity. The new advisory committee will help FDA understand the benefits and risks associated with use of digital health technologies and help identify potential risks or unintended consequences relating to digital health policies or regulations.
  •       FDA’s publication in December of a draft guidance describing the process of applying for and obtaining an Advanced Manufacturing Technology (AMT) designation. The Advanced Manufacturing Technologies Designation Program was created with the enactment of FDORA, which describes an AMT as a manufacturing method that “incorporates a novel technology or uses an established technique or technology in a novel way, that will substantially improve the manufacturing process for a drug while maintaining equivalent, or providing superior, drug quality.” Examples of AMTs include continuous manufacturing and 3D printing. It will be interesting to watch this new regulatory program develop and to track the extent of the benefits that may accrue to both manufacturers and drug applicants.

And Fulfilling Ongoing Regulatory Mandates  

On top of all of these regulatory challenges and the agency’s intensive work to modernize its approach to regulating medical products, it has continued moving forward in a variety of areas that represent the “bread and butter” of FDA. Most notably, perhaps, was the November 27, 2023 culmination of the 10-year rolling compliance mandates created by the Drug Supply Chain and Security Act (DSCSA). Technically the DSCSA is now fully in effect and all trading partners are required to provide, receive, and maintain electronic documentation about prescription drugs and their chain of ownership from manufacturer to dispenser at the package level. At the same time, however, the agency announced a one-year “stabilization period” to give trading partners more time to work out any kinks in their interoperable systems and to “ensure continuity of the supply chain.” Successful implementation of the 10-year implementation plan for the DSCSA is a significant achievement for both FDA and all trading partners in the pharmaceutical supply chain, and stakeholders who have been working extremely hard to reach this milestone should be recognized for their important contribution to the public health. 

Although we can say that the agency essentially met the DSCSA deadline established by Congress ten years ago, in another area of the agency’s mission its actions were much less timely. In November, FDA finalized a proposed rule issued in 2010 to amend the prescription drug advertising regulations to specify that direct-to-consumer (DTC) ads presented in television or radio format must present its major statement relating to side effects and contraindications in a “clear, conspicuous, and neutral” (or “CCN”) manner and establishing standards for what CCN means in the context of a DTC ad. These new regulations – which become effective on May 20, 2024 even though companies have until November 20, 2024 to comply – were ordered by Congress in the 2007 amendments to the FD&C Act, making FDA’s issuance of the final rule seem quite late indeed. But better late than never, in our view! The agency’s articulation of how to meet CCN disclosure requirements is a welcome addition to the regulations that govern prescription drug ads.  

Finally, as noted above in the introduction, December 29 of this year is the one-year anniversary of FDORA, which coincides with the ushering in of a new era for cosmetic manufacturers and distributors under one section of those amendments to the FD&C Act. The compliance date for most provisions created by Modernization of Cosmetics Regulation Act (MoCRA) was one year after it was signed into law, so with the exception of facility registration and listing requirements – which FDA has given affected industry an additional six months to comply with – stakeholders subject to the law should be meeting all other MoCRA requirements as of December 29, 2023 (e.g., reporting serious adverse events). 

Other initiatives mandated under FDORA also received significant attention from the agency over the course of 2023, including the key public health goal of increasing diversity in the clinical trial enterprise. Specifically, as required by the law, FDA convened a public workshop at the end of November, in collaboration with the Clinical Trials Transformation Initiative, to obtain input on how to move the needle on these long-standing (but now congressionally prioritized) diversity and inclusion goals. We expect much more activity in this space in 2024 and beyond.

Look out for our companion post in January with some predictions for the coming year. Happy Holidays!! 

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Joanne counsels global clients on the regulatory and distribution-related implications when bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized.
Benjamin advises pharmaceutical, medical device and biotech companies on the FDA regulatory process to identify the correct regulatory pathway, assisting with FDA communications and strategy.