US regulators will now expedite review of new medicines deemed as promoting “the health interests of Americans”. The FDA aims to review select drugs in one to two months, significantly faster than its usual accelerated approval process. Companies that receive “national priority vouchers” will have access to streamlined reviews and extra communication with the agency.
The initiative follows FDA Commissioner Marty Makary’s push for the agency to challenge assumptions and rethink procedures. Makary has suggested the possibility of rapid or instant reviews, citing the COVID-19 vaccine rollout as an example. The new program will issue limited “national priority vouchers” to companies aligned with US national priorities, giving them access to accelerated communication, streamlined staff reviews, and early submission of product information.
While the initiative overlaps with existing programs, it grants unprecedented discretion to FDA officials in selecting which companies can benefit from faster reviews. Makary prioritizes vouchers for products addressing health crises, innovative cures, or unmet public health needs. An administration official said the program maintains rigorous clinical standards while streamlining bureaucracy.
This move is part of a broader effort by Makary and Health Secretary Robert F. Kennedy Jr. to promote rapid accelerated drug approvals. They have announced stricter policies on vaccine updates, including new testing requirements for seasonal shots in healthy children and adults.
Source: https://apnews.com/article/fda-drugs-makary-trump-accelerated-approval-752146d97521b1644c9b10f2c6361f33