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Jill Wechsler is Pharm Exec's Washington Corespondent
Administration officials continue to rush through new rules and decisions that appear to challenge the independence and effective operations of FDA.
As the Biden administration readies to take over the reigns of government, top administration officials continue to rush through new rules and decisions that appear to challenge the independence and effective operations of FDA. One new requirement could revise oversight and review for prescription drugs and certain medical devices. This follows adoption of a broader new rule to “sunset” many established regulations and programs in the Department of Health and Human Services (HHS) unless they can justify their continuation. And in another area, the administration has tried to push through a new plan blocking FDA oversight of genetically modified animals despite strong objections from agency leaders.
The task of dealing with these issues may fall to Janet Woodcock, who appears poised to serve as acting FDA commissioner until the Biden administration selects and gains confirmation of a new leader for the agency. Woodcock was recently named medical advisor to commissioner Stephen Hahn and has been director of the Center for Drug Evaluation and Research (CDER) for many years, but was detailed to head up development of anti-COVID-19 therapeutics under Operation Warp Speed.
A sign of FDA’s difficult position is the recent White House move to block Hahn from selecting a replacement for departing chief counsel Stacy Cline Amin. Just as the commissioner named experienced attorney Mark Raza to fill the job during the administration’s final days, HHS announced that political appointee James Lawrence would become FDA’s chief counsel, where he could continue the administration’s deregulatory campaign.
A late surprise from the Trump administration is the plan for FDA to publish new information on drug approval timelines and to explain and justify when reviews exceed 180 days. Touted as a “transparency” measure, the new policy instructs FDA to provide data on each approved application for new drugs and generics stating dates filed and approved and number of days over the statutory 180-day timeframe. CDER currently has user fee review goals of 10-months for most new drugs and generics and 6 months for priority therapies, but change would require the agency to collect and report data on review time frames using different metrics. The larger fear is that this policy could lead to more onerous requirements; at a minimum it’s seen as a meaningless distraction at a time when all hands are overloaded with initiatives to address the pandemic.
A related HHS policy would waive FDA premarket review for certain medical devices. This extends the current review exemption under the COVID-19 health emergency for items such as gloves, personal protective equipment, ventilators, and infusion pumps. Not a critical change, but regarded as another challenge to FDA internal policy making.
In addition, the battle over FDA authority to regulate laboratory developed tests (LDTs) continues to create problems. A contentious issue for several years, HHS revoked FDA’s authority over such tests in August in response to pressure from private labs for reduced regulation. However, in November, HHS reinstated FDA’s authority to issue Emergency Use Authorizations (EUAs) for lab tests in order to provide companies with liability protection for erroneous results during the pandemic. By then, however, FDA staff claimed a lack of resources to handle this activity, prompting a shift to outsourcing the EUA reviews.
The most contentious challenge to FDA’s authority, though, involves a late move by the Trump administration to shift oversight of genetically modified animals to the Department of Agriculture, a move backed by industry working in this area. Commissioner Hahn evidently refused to sign an HHS memorandum of understanding authorizing the change, claiming that it required further analysis of the legal and health repercussions.
On another front, FDA staff has had to accept administration efforts to limit utilization of prescription drugs to induce an abortion. In March 2020, FDA was able to relax in-person dispensing requirements for many drugs, including certain controlled substances to reduce the risk of spreading COVID-19. However, the Trump administration left in place the specific rule requiring women to make in-person visits to a clinic or doctor’s office to obtain mifepristone, one of two drugs required for a medication abortion. Even though a U.S. District Court judge suspended the in-person pick-up rule during the health emergency, the administration continued to fight for its reinstatement and recently gained a ruling to that effect from the Supreme Court.
Many of these recently issued regulations and policies can be rescinded or dropped by the Biden administration under established transition practices. However, these efforts by the Trump administration to limit FDA’s authority have rekindled calls for FDA to become an independent regulatory agency, separate from HHS.
As he prepared to exit the agency amidst all the political infighting, commissioner Hahn joined with Anand Shah, deputy commissioner for medical and scientific affairs, in issuing a report outlining FDA’s important achievements in combatting the “devastation and turmoil” wrecked by the COVID-19 pandemic.1 The report highlights the agency’s accomplishments and offers recommendations for continuing to address the still-evolving public health emergency. To improve FDA’s emergency response and ability to sustain innovation, it calls for strengthening the EUA process, government partnerships, innovation in clinical trial conduct, and supply chain surveillance, among many other strategies. Hahn and Shah emphasize that FDA decisions are based on rigorous science and aim to protect and promote the health and safety of American patients.