The Shutdown and the FDA: What Pharma Companies Need to Know

In the process of working with the FDA? Expect delays.

By Joel M. Wallace and Imron T. Aly, partners, Schiff Hardin

As the government shutdown stretches on, pharmaceutical companies must manage the partial shutdown of the U.S. Food and Drug Administration (FDA). The longer the shutdown lasts, the more likely that FDA review of applications will be delayed, affecting company launch plans and business strategies.

Because the FDA is partially funded by filing fees, some of the agency’s application review capabilities will continue for about a month. But after a month of shutdown, applications will likely not receive further review. Even this month, the status remains uncertain. The 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.

What Pharmaceutical Companies Should Consider

Companies with applications on file should stay connected. Those applications should be receiving some level of review for the next month. If the shutdown drags on, this will likely affect the FDA’s ability to complete its review of pending applications by the target action date. This could affect business plans, as it creates uncertainty about likely launch dates.

Companies should try to stay in contact with FDA file managers if possible to determine if target dates will be missed. This is particularly important for applications with target action dates in January or February 2019, which are most likely to slip due to the shutdown. Additionally, once the shutdown is over, companies may need to expedite responses to information requests to meet target dates and keep business plans on track.

Review launch plans since the FDA is not taking new applications. Unfortunately, the FDA announced that it cannot accept new applications or submissions that require a fee payment, due to the lack of a budget. This includes the submission of any new NDA or ANDA. Obviously, this raises serious concerns for the pharmaceutical industry.

If a company were targeting a specific approval or target action date based on a January 2019 submission, then those dates will need to be adjusted. Once the shutdown is over, there will likely be a backlog of applications that have been submitted, but not accepted for filing by the FDA. This could drastically affect the official start of review of many applications. Companies should pay close attention to the pipeline of new applications and may need to adjust launch plans. Application acceptance also triggers many statutory duties and potential exclusivities. Companies should be in close contact with their regulatory affairs and legal teams to determine whether these dates will be moved, and if corrective action will be necessary.

Expect litigation slowdown and inspection delays. Relatedly, anecdotal evidence has come in that government attorneys representing the FDA have been asking to stay litigation pending the shutdown. This litigation slowdown may also be affecting FDA review of citizen petitions, used to request agency action on technical issues.

The FDA has also made clear it will be shifting focus away from ANDAs and NDAs still in process, with the FDA Commissioner tweeting that "One action we’ll be taking is to re-allocate user fee money from certain pre-market drug review work to post market drug safety surveillance." So if a company is awaiting review and approval, and likely also manufacturing facility inspections and recertifications, the shutdown is expected to delay approvals and related activity if extended much further.

Don't miss your Daily Dose.  Subscribe to our eNewsletter here!

Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.

Comments

No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments