Dec 12 (Reuters) - Leaders at the U.S. Food and Drug Administration have pressed internally for reviewers to speed up their evaluation of Eli Lilly's experimental weight‑loss pill, after the company pushed for a faster timeline, documents seen by Reuters show.
The FDA Commissioner's Office has said it wants to cut the time reviewers spend checking whether drug applications have enough material from 60 days to one week for Lilly's pill and other medicines under a new, speedy review pathway, according to the internal documents.
After internal pushback, the Commissioner's Office said it may cut those filing reviews to two or three weeks based on the application's complexity, though Reuters could not confirm whether any change was likely to be implemented and the situation has been fast moving.
If adopted, a new timeline could deliver Lilly a verdict on its pill by as early as March 28, ahead of the May 20 deadline reviewers had set, documents show. Novo Nordisk is expected to launch its weight-loss pill in December or January.
Novo and Lilly currently dominate the lucrative obesity treatment market that analysts estimate could be worth $150 billion annually by the early 2030s, with their highly effective drugs designed to mimic the appetite‑suppressing GLP‑1 hormone.
Lilly's pill helped patients lose 12.4% of their body weight in a late-stage study. In a separate trial, Novo's led to 16.6% weight loss.
Launched in June, the Commissioner's National Priority Voucher program aims to fast‑track FDA decisions for drugs with critical public health or national security impact. The agency has issued 15 vouchers so far, promising one- to two-month reviews versus the usual 10 to 12 months.
Unless it shortens the overall review clock, however, the commissioner's voucher program will give orforglipron the same six-month timeline as under its existing priority review process. FDA Commissioner Marty Makary has pledged to speed drugs and other products to market.
LILLY PRESSED FOR SPEEDY REVIEW
Lilly was granted a voucher for its obesity pill, orforglipron, in November as part of a deal with the Trump administration to lower the prices of its weight-loss medicines for government programs and cash-paying patients. Lilly CEO David Ricks said that day he expected a March decision.
Lilly has since pressed for a swift review, first requesting a 60-day period with a target approval date in January, documents show. While the Indianapolis-based drugmaker acknowledged FDA's independent decision-making authority, the company also highlighted its deal with the White House in communications with FDA staff, the documents show.
FDA reviewers set a 180-day period, however, with a target decision date of May 20. Lilly then argued for a March 30 verdict as it had a complete application ready, allowing technical and labeling reviews to run alongside the filing evaluation.
Lilly said the FDA never indicated a filing period to check for sufficient material was required under the new program. But the FDA reviewers maintained the longer, 180-day schedule, the documents show.
The FDA requires companies to submit chemistry, manufacturing data and draft labeling at least 60 days before a final application under the commissioner's voucher program, according to its website. By law, reviewers must assess any final drug submissions within 60 days, and the FDA has said its final review under the new voucher scheme takes about two months, leading to a total six-month timeline.
But on Monday, FDA Deputy Chief Medical Officer Mallika Mundkur told staff that the commissioner's office would like the filing evaluation time reduced from 60 days to one week, documents show.
It is unclear what prompted the commissioner's office to reduce the filing evaluation times, and whether Lilly's drug would be approved by March.
A Lilly spokesperson said its drug was chosen for the voucher because it was innovative, addressed an unmet public health need and aligned with its focus on increasing affordability. The spokesperson said they expect the FDA to conduct a fulsome review of the benefit and risk data on orforglipron and make a science-based decision.
Andrew Nixon, a spokesperson for the U.S. Department of Health and Human Services, said the voucher program seeks to address critical national health priorities without compromising safety.
"FDA's reviewers apply the same standards and processes to all applications, and efforts to improve efficiency through the CNPV program do not alter the agency's independence or its commitment to rigorous review," Nixon said.
COMMISSIONER NAMES COUNCIL FOR VOUCHER PROGRAM
Unlike other FDA approval pathways, which Congress designed with clear rules, the commissioner's voucher is untested with developing guardrails.
Other drugs selected for the program include a high-dose version of Novo Nordisk's Wegovy, Disc Medicine's porphyria drug bitopertin and Regeneron's DB-OTO for deafness. Some candidates were invited to participate, others applied.
Last week, Makary created an internal FDA review council to evaluate drugs under the program and make a recommendation to the principal deputy commissioner. Council members include personnel from Makary's office, along with FDA drugs division heads Tracy Beth Hoeg and Vinay Prasad. Makary chairs the group but does not vote, documents show.
One FDA source, who was not authorized to speak publicly, said the speedy review timelines and political approval process are alarming.
"Americans will be at risk with this approach," the source said. "The mandate for speed, instead of quality, creates a real possibility that a safety or efficacy issue will not get the meaningful attention it deserves, or that it will be missed entirely."
(Reporting by Patrick Wingrove in New York and Dan Levine in San Francisco; Editing by Michele Gershberg, Caroline Humer and Bill Berkrot)
Dec 12 (Reuters) - Leaders at the U.S. Food and Drug Administration have pressed internally for reviewers to speed up the...
