Apr 7, 2017

Gottlieb could speed up FDA drug approvals

J. Scott Applewhite / AP

Trump's nominee to head the FDA, Scott Gottlieb, has previously proposed a controversial plan: speed up the process for drug approvals under the agency and have politically appointed officials, not doctors, decide which drugs will be approved.

The inspiration: The European Medicines Agency — the European counterpart to the FDA — evaluates new drugs using "a body of politically appointed (and therefore politically accountable) officials, drawn from the European Commission." That means the FDA's European counterpart drug approval process exists outside the agency that evaluates them.

Why it matters: This plan could hurt the FDA's credibility, as drug approvals would become politically motivated by the appointed body Gottlieb proposed.

The FDA's drug approval process is already faster than the European Union's agency. Researchers found that the FDA took an average of 306 days to approve 170 drugs for marketing in the US, according to the New England Journal of Medicine. The European Medicines Agency spent an average of 383 days to approve 144 new drugs for marketing, the study found, so many are challenging the efficacy of Gottlieb's plan to change the review process in the US.

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