FDA Delays Reviews for Eli Lilly, Sanofi, and Others in New Priority Voucher Program Due to Safety and Efficacy Concerns

The U.S. FDA delayed reviews of drugs from Eli Lilly (orforglipron weight-loss pill, now due April 10, 2026), Sanofi (Tzield for type 1 diabetes, delayed over a month due to a treatment-related death, seizures, and blood clotting), Disc Medicine (bitopertin for rare blood disorder, delayed two weeks over efficacy data and abuse risks), and Boehringer Ingelheim (zongertinib for lung cancer, now mid-February).134

The Commissioner’s National Priority Voucher Program, launched in June 2025 under the Trump administration, aims for 1-2 month reviews for drugs meeting public health, national security, U.S. manufacturing, or low-price criteria, shortening standard 10-12 month timelines.13

Delays stem from FDA scientists flagging safety and efficacy concerns; experts view them as reassuring signs of rigorous review process.12

Sanofi’s Tzield delay was from an original November 21, 2025 target; companies have up to two years to submit after receiving vouchers.1

At least seven drugs are in the program, with only one generic antibiotic approved so far; shares of affected companies slipped on the news.24

Sources:

1. https://whbl.com/2026/01/15/exclusive-us-fda-delays-two-drug-reviews-in-new-voucher-program-after-safety-efficacy-concerns/

2. https://ground.news/article/us-fda-delays-two-drug-reviews-in-new-voucher-program-after-safety-efficacy-concerns_a89500

3. https://www.biospace.com/fda/fda-delays-decision-for-lillys-obesity-pill-orforglipron-other-priority-voucher-awardees-report

4. https://stocktwits.com/news-articles/markets/equity/disc-medicine-sanofi-eli-lilly-shares-slip-on-reports-of-fda-increasing-review-time-for-drugs/cmU1rSfR4JO