Drugs

Commissioner’s National Priority Voucher Program

FDA says it is launching the Commissioner’s National Priority Voucher (CNPV) program under which drug developers may redeem vouchers to participate in an agency program that shortens the review time from about 10-12 months to 1-2 months following submission of a final drug application. An FDA notice says the agency will convene experts for a team-based review rather than using the standard review system of a drug application being sent to numerous offices.

“Clinical information will be reviewed by a multidisciplinary team of physicians and scientists who will pre-review the submitted information and convene for a one-day ‘tumor board style’ meeting,” it says.

FDA commissioner Martin Makary is quoted as saying, “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…. As a surgical oncologist, we often made multidisciplinary decisions with a team of doctors on major life-and-death questions for patients, incorporating the latest medical studies in a one-day tumor board-style discussion. This voucher harnesses that model to deliver timely decisions for drug developers.”

The notice says the agency plans to give a limited number of vouchers to companies aligned with U.S. national priorities in the first year. In addition to the program benefits, it says, FDA may also grant an accelerated approval if the product for which the product is used meets the applicable legal requirements for such an approval.

The notice defines the relevant national priorities as addressing a U.S. health crisis, delivering more innovative cures for the American people, addressing unmet public health needs, and increasing domestic drug manufacturing as a national security issue.

To qualify, FDA says, sponsors must submit the chemistry, manufacturing, and controls portion of the application and the draft labeling at least 60 days before submitting the final application. Sponsors must also be available for ongoing communication with prompt responses to FDA inquiries during the CNPV review.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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