Drugmakers voice legal concerns about speedy FDA review program

Some major drugmakers are using the FDA Commissioner's National Priority Voucher Program while other leading companies are hesitating over potential legal and safety risks; the program allows the FDA commissioner to issue approval decisions in one to two months for a limited set of drugs.

More than half a dozen major drugmakers are taking part in the Trump administration's faster review pathway for new medicines, while other leading companies are declining or hesitating because of legal and safety concerns. The FDA Commissioner's National Priority Voucher Program, unveiled in June, permits the FDA commissioner to issue approval decisions in one to two months for a limited number of drugs. Supporters say the pathway prioritises top products rather than cutting corners. Some company executives and former agency officials have raised questions about scientific rigor, transparency and the program's durability beyond the current administration. Key facts: - More than half a dozen major drugmakers are participating in the program, while other leading firms have said they will not pursue it or are cautious, Reuters reported. - The National Priority Voucher Program allows one- to two-month approval decisions for drugs deemed critical to public health or national security, or those manufactured in the U.S. or offered at low prices. - The FDA previously offered a fast-track review of six to eight months for priority medicines, with standard reviews taking up to a year. - The agency has issued 18 vouchers so far, including Eli Lilly's widely anticipated weight-loss pill and products from Merck, GSK, Johnson & Johnson and Regeneron, according to reporting. - Some reviews in the program have taken around four months, while other reviews were delayed after agency scientists raised safety or efficacy concerns, including a reported patient death in one case. - Former FDA official Richard Pazdur and some industry sources raised broader concerns about politicization and transparency; a Department of Health and Human Services spokesperson said decisions are grounded in evidence-based science. Summary: The program has prompted caution across the pharmaceutical industry because of legal and scientific questions about very short review windows. The FDA has issued multiple vouchers and is handling several priority filings with mixed review times and some delays for safety concerns. Undetermined at this time.