FDA to offer faster drug reviews to companies promoting 'national priorities' [View all]

[BumRushDaShow]

Source: WTAE-TV Pittsburgh, PA/AP

Updated: 8:02 PM EDT Jun 17, 2025


WASHINGTON — U.S. regulators will begin offering faster reviews to new medicines that administration officials deem as promoting “the health interests of Americans,” under a new initiative announced Tuesday. Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months. FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to “challenge assumptions” and rethink procedures. In a medical journal commentary published last week, Makary suggested the agency could conduct “rapid or instant reviews," pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed.

For the new program, the FDA will issue a limited number of “national priority vouchers” to companies “aligned with U.S. national priorities,” the agency said in a statement. The special designation will give the selected companies access to extra FDA communications, streamlined staff reviews and the ability to submit much of their product information in advance.

Speeding up drug approvals has long been a priority of the pharmaceutical industry, which has successfully lobbied Congress to create a variety of special programs and pathways for faster reviews. Many aspects of the plan announced Tuesday overlap with older programs. But the broad criteria for receiving a voucher will give FDA officials unprecedented discretion in deciding which companies can benefit from the fastest reviews.

Read more: https://www.wtae.com/article/fda-fast-drug-approval-voucher-program/65091142

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They laid off most of the Reviewers in CDER and even fired (and then had to rehire) the PDUFA-funded Reviewers, so how do they propose to accomplish this nonsense?

From the OP article -

the agency will aim to review select drugs in one to two months. FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

Impossible. It's basically a "hand-wave" approval.