Overview
- The FDA commissioner’s new voucher program allows qualifying drug companies to have their applications reviewed in one to two months instead of the standard ten to twelve months.
- Eligible companies must demonstrate support for U.S. priorities such as expanding domestic drug manufacturing, improving affordability, and addressing urgent public health needs.
- The agency plans to deploy artificial intelligence tools and increase reviewer accessibility to accelerate document review while claiming no compromise to scientific rigor.
- By offering one-month turnaround reviews, the FDA expects to create incentives worth more than $100 million in market value for companies that meet its criteria.
- Critics warn that granting the commissioner broad discretion over voucher awards could invite political influence and weaken safeguards against premature drug approvals.