FDA Policy Head on Major Trump Changes at FDA
Restructuring drug user fee programs and bringing drug manufacturing and R&D home from offshore locations are primary objectives of the Trump Administration, according to newly appointed FDA deputy commissioner for policy, legislation, and international affairs Grace Graham. Addressing the Food and Drug Law Institute’s annual meeting 5/16, Graham questioned five- to 10-year estimates that skeptics have recently cited for the amount of time it might take to get U.S. drug manufacturing facilities converted or built and made operational.
“My FDA colleagues have provided examples where we’ve gotten it down to one or two years, which is great, but again, not all of this is on FDA’s shoulders,” she said. “There's a myriad of federal, state and local requirements for new construction, ranging from building standards and zoning restrictions and environmental protocols, but we do play an important role and even in expanding existing capacity for modifying existing production lines to produce a new or a different product.” Graham said the agency is looking internally at existing policies to see where it can provide clarity on how to reduce the amount of time it takes to get a new domestic pharmaceutical manufacturing facility operational.
Graham, who came to FDA last month after more than 13 years as a Capitol Hill staffer, including serving as the House’s chief health counsel for the past four years, noted the importance of the user fee programs and how they have grown to provide key funding for the agency. “But as we look towards the next reauthorization, it is time to take a step back and think about if the fee structures and amounts have any unintended consequences,” she told FDLI. “The perception of a company handing over a multi-million dollar application fee when they’re submitting their application may cause some American people to question the outcome of those reviews. It is worth exploring whether and how restructuring and simplifying the user fee programs may help rebuild trust in the FDA and its decisions and take advantage of the upcoming reauthorization to do so.”
Under the current administration’s Make America Healthy Again agenda, Graham said FDA will look to see if additional studies are necessary on older drugs that are frequently used off-label. “Many drugs we use today are used in ways maybe not envisioned or supported by the data that’s collected at the time of review and approval, and many having gone generic, and the incentives to do those continued studies may no longer be there,” she told FDLI. “I think FDA may play a role in facilitating that conversation about the data and how drugs are used today, and are there label changes or updates that need to happen.”
Regarding the increasingly global nature of clinical trials and where more and more innovative products are being developed in China first or other countries, Graham said there is a collective role for FDA, industry and developers to work together to try to reverse this trend. She said the agency can play a part to streamline and modernize regulations, noting that the good laboratory practices regulations have not been updated since the 70s. “That’s something that we can take on, but it’s going to take a lot of us — institutional review boards, hospitals, clinicians, patient organizations — to really think about how we can make sure trials are done here, and we need to address it.” She said stopping the trend will also protect the infrastructure in the U.S. needed to perform the research, thus ensuring competitiveness in the future.
Graham drew her audience’s attention to the U.S’s reliance on other countries, “which may not have [our] best interests in mind, to manufacture critical medications.” She said about 73% of all FDA-registered manufacturing facilities are outside the U.S., with China as the leading supplier.