The U.S. Food and Drug Administration (FDA) has announced the first recipients of its new “national priority” vouchers aimed at expediting drug reviews. Nine innovative treatments have been selected under this initiative, including gene therapies and medications for various health conditions.
Details of the FDA’s National Priority Vouchers
On a recent Thursday, the FDA revealed that these nine treatments are part of a pilot program designed to significantly shorten the evaluation period for drugs. This could reduce the typical review time to as little as one to two months. The FDA usually has up to ten months for a decision following a company’s application.
- Program Launch: June 2023
- Standard Review Duration: Up to 10 months
- Priority Review Duration: Up to 6 months
- Potential New Review Duration: 1-2 months
Selected Treatments
The selected treatments come from notable companies such as Regeneron Pharmaceuticals and Revolution Medicines. Some highlighted therapies include:
- DB-OTO: A gene therapy targeting a genetic form of deafness.
- RMC-6236: A promising treatment for tough-to-treat pancreatic cancer.
- Cytisinicline: A drug aimed at helping individuals quit using e-cigarettes.
- Pergoveris: A treatment from EMD Serono focusing on infertility.
Program Goals and Criteria
The national priority vouchers are designed to address critical U.S. health challenges. The FDA’s selection process focuses on products that align with national health priorities:
- Addressing public health needs
- Making medicines more affordable
- Increasing domestic drug manufacturing
FDA Commissioner Martin Makary emphasized that while the selections do not guarantee approval, the goal is to minimize delays in the review process.
Future of the Voucher Program
The FDA plans to announce a second batch of recipients in the coming weeks. This initiative arrives during a resurgence in the biotech sector, driven by favorable market conditions and evolving drug-pricing policies.
Overall, the national priority voucher program may enhance regulatory efficiency for innovative biotech drugs, potentially benefiting both manufacturers and patients alike.
