Government Shutdown Day 33: The Impact on Drug Approvals

As the longest government shutdown in history continues, we at Vodori are wondering how the industry is fairing. Will our customers awaiting FDA approvals see their PDUFA dates slip? How is the FDA monitoring drugs and devices already on the market? Are companies still being subjected to audits during this time?

Here’s what we’ve learned so far:

• NDAs submitted prior to the shutdown that included a user fee are still being reviewed. On January 14th, Scott Gottlieb, FDA Commissioner, tweeted, “For products covered by a user fee program, if the product sponsor submitted the application and paid any required fees before the lapse, FDA can use its limited carryover user fee funding to continue reviewing the application.”
• New Drug User Fee funding is expected to last through the end of February. The “limited carryover” fees Gottlieb mentions above were originally expected to last until mid-February, but he recently announced that fees could carry them through February 28th.
• Medical Device User Fee funding will last longer as BioPharma Dive indicated that these user fee programs have months of funding remaining.
• The FDA could re-allocate some of these funds to post-market drug safety. According to the National Law Review, “FDA announced that it may take some funds for application review and shift them to post-marketing surveillance. This decision is driven by the need to ensure safety of the supply of already-approved drugs.”
• Drug applications that don’t include a user fee are not being reviewed. This includes Investigational New Drug (IND) and Biologics License Application (BLA) applications, except for emergency ones.
• No new drug applications are being accepted until the government is reopened.  Gottlieb tweeted, “During the lapse, FDA cannot accept new medical product applications that require a fee payment. We are not allowed to accept new user fees. In these cases, sponsors will need to wait until the lapse is over to submit their applications to FDA for review.”

While the current government shutdown has now reached an unprecedented length and it is unclear when it will end, we have not yet seen the full ripple effect for life science companies and the patients they serve — the impacts of altered business plans for companies and affected health outcomes for patients becoming greater with each passing day.

We’ll keep you updated as we learn more, and we hope to hear good news of restored FDA funding soon.