7:08 PM
Jan 04, 2019
 |  BioCentury  |  Politics, Policy & Law

Budget woes may linger at FDA

How a promised FDA budget boost could fall victim to shutdown politics

The partial government shutdown is hurting patients and drug companies by preventing FDA from accepting most new drug applications, and the harm may not end when the budget stalemate is resolved.

While it isn’t clear how the impasse over President Donald Trump’s demands for funding of a border wall will play out, one resolution could involve Congress abandoning an FDA funding boost that the House, Senate and President Donald Trump have all agreed it should receive.

FDA plans to use the money to promote advanced biopharmaceutical manufacturing technologies that could help prevent bottlenecks that limit access to gene therapies and vaccines, and to improve the quality and consistency of drug reviews.

Many stakeholders see CMC issues as one of the main obstacles to progress in these new modalities.

Without the appropriation, these FDA initiatives would be slowed or derailed. Flat-funding FDA would also complicate an ongoing reorganization of the Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (see “Getting Flatter”).

An alternative scenario sees Congress and Trump settle on an appropriation...

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