From 60 days to 1 week! Senior officials at the U.S. FDA are pressuring internally to expedite the approval of Eli Lilly's oral weight loss drug

Intense discussions are taking place within the U.S. Food and Drug Administration (FDA) regarding the approval timeline for Eli Lilly's latest oral weight loss drug.

On the 12th, multiple internal documents seen by Reuters indicate that FDA executives are pressuring review personnel to significantly shorten the drug application review period from the current 60 days to just one week, in order to expedite the market decision for Eli Lilly's product.

Orforglipron has shown an average weight loss of 12.4% in clinical trials and is expected to become another heavyweight product in the obesity treatment field. If the FDA adopts a faster review pace, Eli Lilly could receive approval results as early as March 28, 2026, nearly two months earlier than the originally scheduled date of May 20.

Meanwhile, competitor Novo Nordisk also plans to launch its oral version of the weight loss drug in December or January next year, as the two giants compete for a global obesity drug market valued at up to $150 billion.

New Review Target Shortened to One Week

The FDA launched the "National Key Priority Voucher" (CNPV) program in June this year, aimed at accelerating the approval of products with significant public health importance. Eli Lilly was approved to participate in the program in November as part of a drug pricing agreement reached with the Trump administration. However, Eli Lilly has since been pushing the FDA for further acceleration, even proposing to compress the overall review period to less than 60 days and requesting a decision by January next year.

However, the review team insists on the current six-month review cycle, believing that the accelerated process must still comply with regulatory requirements, including complete material submission and at least two months for the final review phase. Some reviewers have expressed concerns about the pressure from executives, arguing that rushing the approval could impact safety assessments. An FDA insider bluntly stated that a process so focused on "speed first" could overlook risks, threatening public health.

Despite the controversy, the FDA director's office has again requested to reduce the initial material review period from 60 days to one week; amid internal opposition, the latest proposal may change to 2 to 3 weeks, but whether it will be implemented remains uncertain.

Eli Lilly stated that Orforglipron was selected for the accelerated program due to its innovation and unmet public health needs, and the company looks forward to a "comprehensive and scientific" evaluation by the FDA. The U.S. Department of Health and Human Services responded that accelerated reviews will not affect review standards, with safety remaining the top priority.

As obesity drugs become a highly focused area for Wall Street and regulators, the balance between "efficiency and safety" within the FDA is being redefined, and the competition between Eli Lilly and Novo Nordisk will also drive the industry towards higher regulatory sensitivity