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Government Shutdown Means New Drugs May Have to Wait – But Safety Monitoring Will Continue

Posted on January 17th, 2019 by in Pharma R&D

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The partial shutdown of the U.S. government, which began just before the Christmas holiday, has been especially terrible for hundreds of thousands of federal employees who are either furloughed or working without pay. But as the shutdown has continued to drag on into the new year, the ripple effects are hitting more and more people and industries. Pharmaceutical companies, too, could begin to feel the pain due to hiccups in the drug approval process at the FDA, where approximately 40% of workers are among those furloughed.

On January 10, Joshua Cohen of Forbes reported that the FDA has been able to continue doing reviews and approvals for new drugs and biologics thanks to fiscal year 2018 user fees, but that they aren’t accepting FY 2019 fees until funding appropriations have been authorized. “Consequently, the FDA has suspended reviews of existing Investigational New Drug (IND) and Biologics License Application (BLA) applications not covered by user fees, and is not reviewing applications for new drugs and biologics submitted during the shutdown period, except for emergency INDs and BLAs.”

With funding for application reviews expected to run out by early February, drug makers are getting nervous. In evaluating upcoming regulatory decision dates, STAT determined that “new drugs from Janssen, Sanofi and Novartis for depression, diabetes and multiple sclerosis, as well as a host of other potential new therapies” are among those whose planned timelines are now threatened. The uncertainty has many pharma firms frustrated.

Hopefully most of the Big Pharma players are prepared to ride out this bureaucratic slowdown – after all, drug development is a process that is often plagued by difficulties and delays. But, noting the dwindling funds for medical device and generic drug approval programs, BioPharma Dive points out that resulting delays in approvals could be especially problematic “for smaller pharma and biotech companies who will be relying on projected income of new therapies.”

The delay of drug approvals is no small matter – both for pharma and for the patients that stand to benefit from new therapies – but perhaps most vital is that patient safety monitoring continue, regardless of funding. On January 13, FDA commissioner Scott Gottlieb announced on Twitter that certain FDA activities would be continued or expanded because they were deemed to have a direct safety or life-saving impact. These activities include “food, drug, medical, device and pharmacy compounding surveillance inspections focused on the highest risk products and facilities” and “monitoring and evaluating medical device adverse event and malfunction reports to include additional types of medical devices.”

As of this writing, the shutdown has been going on for 26 days, longer than any previous government shutdown in the U.S. Though it could be re-opened at any moment, both political parties have shown little sign of budging, and President Trump ominously suggested it could go on for months (or even years). Here’s hoping that Washington D.C. can get its act together sooner than later, so that the FDA can continue fulfilling its responsibilities and resume paying its employees.

 

 

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