The federal government entered into a partial shutdown at midnight on Saturday, December 22, 2018. The implications of the ongoing shutdown are far-reaching, but its impact on the Food and Drug Administration (“FDA”) is of particular concern to members of FDA-regulated industries and those with a role in ensuring the public health. Thousands of FDA employees considered non-essential were furloughed and, consequently, routine regulatory and compliance activities at FDA were put on hold. On his Twitter account (@SGottliebFDA), Scott Gottlieb, M.D., Commissioner of the FDA (“Dr. Gottlieb”), has tweeted frequent updates regarding FDA operations. As he explained, FDA officials initially consulted with public health experts and other senior leaders regarding which FDA activities address threats to human life and safety and, thus, should continue during the shutdown.
Many FDA operations halted for two weeks during the holidays, according to schedule. Accordingly, many activities were not considered delayed until early January when FDA was scheduled to resume all operations. To provide examples of the shutdown’s implications at FDA, FDA is currently not accepting new medical product applications that require fee payment or reviewing drug applications that are not user-funded, and FDA’s Center for Drug Evaluation and Research (“CDER”) has paused all non-emergency over-the-counter monograph drug activities because these activities were determined not to address immediate threats to human life and safety. In addition, the thirty-day waiting period before sponsors of investigational new drugs may conduct clinical trials is paused during the shutdown unless the drugs are considered emergency drugs.
During the shutdown, FDA will utilize carryover “user fee” funding to continue review of certain applications that require a user fee, such as New Drug Applications, Biologics License Applications, and Premarket Approval applications for medical devices, if such fee has been paid. However, FDA may require more time than what agency timeframes allot to review these applications. FDA cannot accept new user fees during the shutdown. If fee payment is required, sponsors must wait until the government reopens. Some companies and industry segments, such as allergenic products, negotiated to be excluded from user fees and chose to instead rely on budget authority. Accordingly, when budget authority lapses, routine review activity for these products halts unless an emergency involving safety of human life warrants review.
As the shutdown entered week three, FDA determined it would resume activities necessary to identify and respond to threats to the safety of human life. On January 15, 2019, furloughed food safety inspectors returned to work without pay after Dr. Gottlieb days earlier sought and received permission from the Department of Health and Human Services and the White House to call the inspectors back to work. Resumed FDA activities include:
- expanded monitoring and analysis of food safety surveillance and detection;
- surveillance sampling of high-risk foods, drugs, and devices;
- expanded monitoring and evaluating of medical device adverse event and malfunction reports to include additional types of medical devices;
- expanded activities related to surveillance and response for recalls as necessary to identify and respond to threats to the safety of human life; and
- expanded inspection activities beyond “for-cause” inspections to also include foreign and domestic food, drug, medical, device, and pharmacy compounding surveillance inspections focused on the highest risk products and facilities.
Resumed activities are being funded by carryover user fees and from the reduction of any overhead charges to CDER and the Center for Biologics Evaluation and Research. Dr. Gottlieb claims these funding sources give FDA roughly five weeks of funding to review new drug applications. FDA is seemingly operating at the best of its ability despite the circumstances. According to Dr. Gottlieb, carryover user fees supported the January 16, 2019 FDA guidance on drug development to treat rare diseases. Also on January 16, FDA issued draft guidance to support companies seeking final approval for tentatively-approved generic drug applications to promote timely access to safe and effective generic medicines. However, the Prescription Drug User Fee Act, which authorizes FDA to collect fees from companies that produce certain human drug and biological products, is the most vulnerable program, likely to run out of money the first week of February.
Manufacturers, researchers, and others involved in the creation of these products should continue to monitor for developments but should expect likely delays in all FDA review activity. Additional operations may resume as determined to be necessary if the shutdown continues. If the shutdown lasts for more than five additional weeks, it is unclear which FDA operations not addressing an immediate threat to human life can continue. Once the government reopens, FDA will still face a backlog of applications and other regulatory activity, almost guaranteeing a ripple effect of delays that will continue for the foreseeable future.