STAT+: Does the FDA commissioner’s new voucher program open a Pandora’s box?

On Tuesday, the Food and Drug Administration said that it would offer U.S. companies that support “U.S. national interests” a voucher to have their new medicine reviewed for approval in one to two months, instead of the 10 months or so products get for a standard review or the six months that are allotted for products for a priority review.

“Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies,” said FDA Commissioner Marty Makary in a statement.

Speeding up drug approvals and creating new incentives for companies makes sense. But there are a lot of ways this program could go wrong.

The biggest: The press release says “the FDA Commissioner will use specific criteria” to make the vouchers available. It is dangerous for the commissioner, a political appointee, to be handing out what appear to be the fastest drug approvals ever.

Here are more issues that the FDA’s statement, its FAQ, and a brief video featuring Makary do not fully address.

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