FDA Restarts Some Drug, Biologic and Device Inspections

Regulatory NewsRegulatory News
| 15 January 2019 | By Zachary Brennan 

Following Sunday’s announcement that more FDA staffers would come back to work without pay, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Tuesday revealed on Twitter the approximate numbers of those returning.

“About 400 total staff are being engaged in this mobilization. The vast majority are inspectors and others are professionals who work in support inspectors,” Gottlieb tweeted.

Of those 400, about 100 will deal with high-risk medical device manufacturing facilities, about 70 are focused on inspections of high-risk drug manufacturing facilities and about 90 will inspect high-risk biologic manufacturing sites. The remaining will deal with food inspections.

Gottlieb also denied missing any inspections since the shutdown.

“Nothing was missed. None were scheduled. Normally the schedule for the first week back from Christmas would have been reduced, but unclear how many we would have scheduled but for the shutdown. Not many. Maybe a few dozen. They’ll be scheduled going forward, starting today,” he said.

In addition, the announcement Tuesday builds on information related to the additional activities, which have been added after careful analysis and in close consultation with senior FDA leaders and public health experts, and include:
  • 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;
  • Surveillance sampling of imported high-risk foods, drugs, and devices, and the logistical coordination and laboratory support for allowable inspections and evaluation;
  • Expanded monitoring of and the evaluation of medical device adverse event and malfunction reports to include additional types of medical devices;
  • Expanded activities related to surveillance and response for recalls (including Class I and Class II) as necessary to identify and respond to threats to the safety of human life.
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Last week, FDA announced it would shuffle funds around to try to better surveil pharmaceuticals rather than to work on drug applications.

And now the first company (more are expected if the shutdown continues) has come forward to announce that FDA will not review its application.

In an SEC filing late Monday, Aimmune Therapeutics, Inc. said it has been notified by FDA that as a result of the shutdown and lapse in funding, FDA will not commence review of its biologics license application.
But some reviews of new drugs will continue for about five weeks.

"We've stretched our resources by lowering burn by basically deferring internal operating charges and shifting money to salaries," Gottlieb told Focus.


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