FDA pilot program shortens drug reviews; “We have to modernize agencies,” Makari said on Biology
The FDA is implementing a new pilot program that could inspire the development of certain new drugs by significantly shortening its regulatory reviews. But to be eligible, the drug must address designated national health benefits.
The FDA has already had a program that could speed up the regulatory review of rare disease drugs. This Priority Review Voucher Program (PRV) was created by Congress and was initially targeted at rare and neglected diseases and later expanded to include rare pediatric diseases. Companies holding PRVs can shorten their drug review to six months, well below the standard 10-month review.
The new credential program created by the FDA is called the Commissioner’s National Priority Certificate (CNPV) program. According to the agency, CNPV for qualified drugs can reduce review to just one to two months. This regulatory speed will come from collaboration within the agency.
Subject drug applications to many FDA offices based on standards review. The FDA said the CNPV review process will convene experts from these various offices for a team-based review. This approach mimics the tumor plate, a practice used in cancer care, where experts from different oncology areas determine the best treatment for patients. The FDA said the CNPV review will include a multidisciplinary team of physicians and scientists participating in a one-day tumor plate-style meeting.
The CNPV announced it was appearing at the Bio International conference held in Boston on Tuesday, FDA Commissioner Martin Makary. Speaking at the conference, surgical oncologist Makary said the United States needs to be creative in the way drugs are evaluated. Makary said the new CNPV program will provide a way to speed up the FDA drug review.
“We need to continue to innovate, we can’t meet it,” Makari said. “We have to modernize AI in our review, start using AI, start thinking about unnecessary steps and delays, conduct more continuous experiments, have endpoints of research in the cloud so that reviewers can browse and see these endpoints, rather than submitting huge applications after each step.
The new voucher program will have some key differences from the rare disease program. Rare disease priority review credentials will not expire, but the program can indeed be renewed by Congress. Legislators did not do so by the end of 2024. PRV has also become a commodity to be bought and sold. Today, the price of vouchers is about $150 million. The FDA said the new national priority certificate is not transferable between companies. Additionally, once awarded to the company, the certificate will expire in two years.
To qualify as one of these new credentials, the FDA said a pharmaceutical company must submit the chemical, manufacturing and control section of the application and submit the final application for at least 60 days, using complete clinical data. The company must also be able to communicate continuously with the agency in order to answer questions quickly during the review. The FDA said that if submitted data or other components are considered inadequate or incomplete, the right to extend the review time window, if the trial results are vague or the review is particularly complex.
CNPV can be directed by the FDA to a company’s specific research new drug. The certificate can also be awarded to the company as an unspecified voucher, allowing the company to use it for new drugs as long as the drug is consistent with the objectives of the CNPV program.
In the first year of the new program, the FDA said it plans to “provide a limited number of vouchers to companies that are aligned with U.S. national priorities.” The ruling of one of these vouchers does not exclude the use of other existing regulatory avenues that may be applicable. For example, drugs using vouchers may also receive accelerated approval as long as the requirements of this pathway are met.
Photo: Getty Images, Sarah Silbiger
