There’s been lots of speculation as to what the government shutdown means for the U.S. Food and Drug Administration — including various reports that our food isn’t getting inspected.
There’s been lots of speculation as to what the government shutdown means for the U.S. Food and Drug Administration — including various reports that our food isn’t getting inspected.
Just over half of the FDA staff members are still working. Those not furloughed are those who perform vital roles around the safety of human life, high-risk recalls, civil and criminal investigations, or certain activities authorized to be funded by carried-over industry user fees.
In large part, it appears that medical products will continue to be reviewed and regulated as usual, according to a memo posted by the FDA. Instead, the FDA is sacrificing much of its oversight of food safety, nutrition and cosmetics, and pausing most laboratory research. But there are still a few implications for the medical device, biotech and pharmaceutical industries.
While the government is shutdown, the FDA can’t collect any user fees assessed for FY2014. Therefore, it can’t accept any regulatory submissions for FY2014 that require a fee, like new drug applications, premarket applications, product development protocols and 510(k)s, unless the fee payment was made before Oct. 1. The House of Representatives voted Monday to restore funding to FDA through the rest of the shutdown, but the measure would still need to pass the Senate to go into effect.
Meanwhile, FDA will continue to accept applications for which the fee has been paid, and applications for which no fee is required, including investigational new drug applications, humanitarian device exemptions, investigational device exemptions and de novos.
So long as resources allow, the FDA said it will continue to also review those medical product applications, although it made a special point to note that certain review activities for medical devices may be suspended due to resource constraints. It approved two new drugs last week.
With regard to biosimilars, the FDA said it doesn’t expect to have access to any Biosimilar User Fee Act funding and won’t perform any review activity in this area, except for emergency work.
Generally, the FDA said, scheduled advisory committee meetings would go continue as scheduled. That’s good news for the several pharma and biotech companies that have pending FDA reviews scheduled for October.
Meanwhile, other branches of HHS have taken bigger hits. The CDC, for example, has paused its influenza tracking program, and the NIH is not admitting new patients to its clinical trials.
[Image credit: Flickr user Magic Madzik]
