Several legislative initiatives on table that would extend agency’s reach.
A notable feature of the Biden administration’s recently proposed 2023 budget for FDA is a package of legislative measures that aim to enhance the agency’s authority and update procedures for regulating medical products. The actual funding increase for FDA is a mere $356 million in budget authority; most of the agency’s added resources come from a wishful $1.6 billion to prepare for future pandemics and from industry-paid user fees, which would increase to $3 billion. The accompanying legislative proposals set the stage for further debate on FDA policies and programs and whether to include some measures in legislation to reauthorize user fees.
No surprise that a leading proposal addresses FDA’s accelerated approval process. The agency asks Congress for wider authority to cancel drugs that gained expedited approval for market but have failed to provide confirmatory post-market studies within set time frames. The measure clarifies that FDA can require manufacturers to provide adequate confirmatory studies as a condition of approval in the first place.
Several provisions address FDA procedures for preventing shortages in drugs and medical devices. There’s a request for authority to extend certain drug expiration dates when companies submit data supporting longer shelf-life listings. And FDA wants notification from medical device makers when there is potential for a shortage, plus regular assessment of supply chains and risk management plans to avoid such developments.
Proposed changes in how the 180-day exclusivity period for new generic drugs is calculated and implemented once again aim to enhance competition among generic drugmakers. Here the legislators seek to prevent a first-approved generic drug from using a range of “parking” strategies to extend market exclusivity. The specifics have raised objections from generic drug makers that it’s unnecessary and likely to limit patent settlements between brand and generic firms that support the current competitive system. A pointed analysis of the proposal available on the FDA Law Blog.1
Several leading lawmakers want to enhance FDA’s oversight authority over dietary supplements. Here they propose to require supplements to be listed with the agency and to boost enforcement for unlawfully marketed products.
FDA also proposes measures to retain its flexibility for conducting remote inspections of manufacturing facilities beyond the pandemic. The agency seeks extended authority to compel manufacturers to participate in remote evaluations and to apply this policy to medical devices and bioresearch monitoring programs. Another measure would require importers to pay for the destruction of medical products found to be counterfeit, instead of FDA or other government agencies having to foot the bill. And manufacturers of certain medical devices would have to assess the cybersecurity of their products more regularly and disclose any apparent risks.
The new budget plan also affects the goals and policies within FDA’s centers. The Center for Drug Evaluation and Research (CDER), for example, looks to use some of any added funds to enhance the agency’s battle against opioid abuse and bolster its ability to ensure the safety of marketed products, says CDER Director Patrizia Cavazzoni. Added top priorities are to advance therapies for rare diseases, to modernize CDER technology platforms, and to strengthen the drug supply chain.
All of these initiatives require adequate staffing, Cavazzoni emphasized during a program sponsored by the Alliance for a Stronger FDA on Monday. This is an ongoing challenge for her, as well as all of FDA. Attrition actually dropped in 2020, as many long-time staffers postponed retirements to help fight the pandemic, she noted. But now vacancies have increased—at a time when CDER needs added expertise to handle its growing workload involving COVID-19, as well as compounding, drug supply chain security and advanced manufacturing. One strategy for attracting new scientists to FDA is to allow them to work remotely; not requiring people to move to Washington, D.C. has “extended our reach,” she pointed out.
The last thing CDER needs is any large organizational change, Cavazzoni added, noting that she is looking for “the right people” to fill the “boxes we now have.” And more connectivity through modernized IT systems within CDER, she believes will further a “true, multi-disciplinary approach” to application review.
To better detect early signals of potential disruptions in the pharmaceutical supply chain, Cavazzoni also emphasized the importance of manufacturers providing FDA with data on volume production for each product at each facility. When a firm has, say, three plants that produce a certain product, it’s critical to know where most of the drug comes from in order to fully understand the impact of a potential shut-down and whether that will lead to shortages, she pointed out.
In addition, FDA needs downstream information from distributors to gain an effective end-to-end picture of the supply chain from manufacturers all the way through to purchasers. The agency’s ability to collect such information was enhanced during the pandemic, but Cavazzoni explained that it now needs to be clearly authorized and funded through the budget process.