PharmExec Blog

Shutdown Forces FDA, HHS No-Shows

Officials from the Food and Drug Administration and the National Institutes of Health were scheduled to explain developments in clinical trial registration and transparency at the Drug Information Association’s conference on Clinical Trial Disclosure in Bethesda, Md. this week. They sent in slides, and one HHS official even pre-recorded his presentation. But the government shutdown kept them from showing up in person.

The annual meeting of the Regulatory Affairs Professionals Society (RAPS) in Boston made it through two days, but had to cancel some sessions on Oct. 1 because FDA participants were instructed to head home. The same thing happened at numerous biomedical research meetings, including some in Europe, because NIH scientists had to leave. The shutdown hit NIH particularly hard, putting three-fourths of its staff on furlough. NIH said it would not accept new grant applications and cancelled meetings, raising concerns about slowing the progress of biomedical research. Most distressing, the NIH clinical center stopped admitting new patients, blocking many seriously ill individuals from anticipated treatment through clinical trials.

Similar problems have hit the Centers for Disease Control and Prevention (CDC), which lost nearly 70% of staffers. The agency said it was unable to support its annual fall flu vaccine program and infectious disease tracking in order to focus on emergencies and disease outbreaks.

FDA is less affected by the government shutdown than many other agencies, as more than half of its workforce is able to stay on the job – many supported by already collected user fees or public health service appointments. The agency said it would continue to handle emergencies and investigate criminal violations and conduct activities funded by user fees. The website for the Center for Drug Evaluation and Research (CDER) has been posting some new documents and data, and review work continues on already-filed applications.

But the agency stopped accepting new regulatory submissions that carry fees and halted routine inspections  of manufacturing facilities and clinical research sites. A number of drug advisory committee meetings are scheduled over the next few weeks, and it’s not clear if they will be held or postponed. The upshot could be missed review deadlines and delays in issuing documents and carrying out programs. And a lot of FDAers may have to scratched from agendas for a number of conferences taking place in coming days.

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