After mass layoffs, the FDA has started missing certain deadlines, pushing one biopharma to delay a phase 3 trial and consider other paths to market, The Wall Street Journal reports.
Women’s health company Daré Bioscience planned on launching a late-stage study this year for an investigational cream designed to treat a sexual arousal disorder in women. But, after experiencing delays at the FDA, the company is postponing the trial and instead looking to bring a compounded version of the drug to market this year, CEO Sabrina Johnson told the WSJ and confirmed with Fierce Biotech.
“Women shouldn’t have to wait for solutions—we will continue to innovate and expand treatment options that improve outcomes for those who need it most,” Johnson said in an April 17 post on LinkedIn.
At the end of last year, the California-based company said it had aligned with the FDA on key study design features and endpoints to test Daré’s investigational topical cream formulation of sildenafil (sold as a pill for men under brand names Viagra and Revatio). At the time, the biopharma said it planned on submitting the protocol and statistical analysis plan to the agency in the first quarter of 2025, with a trial launch slated for the middle of this year.
The first quarter has now passed, and Daré says it is still waiting on a piece of information from the FDA related to the analysis plan.
In the last two months, the agency pushed the date it would provide guidance back twice, the Daré CEO told the WSJ. The feedback the biopharma has received from the agency was “brief” and required further discussion, Johnson said.
Historically, the company had received information about trials within the set time frames, according to the CEO.
The trial launch hanging in limbo delays a second confirmatory late-stage study required to support a new drug application. So, for the time being, Daré is turning its focus to selling the cream as a compounded drug under the FDA’s section 503B rule later this year.
“FDA is actively working to ensure continuity of operations during the reorganization period and remains committed to ensuring critical programs and testing continue,” an agency spokesperson told Fierce Biotech.
Previously, the agency rarely missed deadlines or failed to communicate in a timely manner, Marc Scheineson, a former FDA associate commissioner and healthcare attorney at Alston & Bird, told the WSJ.
“When you cut the administrative staff and you still have these product deadlines, you’re creating an unwinnable situation,” Scheineson told the WSJ. The worst thing for companies is not getting guidance when needed and following all the steps for approval, only to “prepare a $100 million application and get denied because of something that could’ve been communicated or resolved before the trial was under way,” he said.
At the end of March, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced 10,000 layoffs across the federal health agency, including 3,500 full-time FDA employees and 1,200 National Institute of Health workers. The cuts are on top of 10,000 early retirements or “fork in the road” exits.
A few days later, RFK Jr. walked back 20% of the newly implemented cuts, saying 2,000 of the layoffs were done in error.
Key leadership departures—like former FDA Chief Medical Officer Hilary Marston, M.D., and the agency’s former Center for Biologics Evaluation and Research director Peter Marks, M.D., Ph.D., among many others—have compounded the mass layoffs.
While the HHS said the FDA workforce reduction wouldn’t impact drug, medical device or food reviewers, some say it already has.
Earlier this month, hundreds of biotech stakeholders penned a letter expressing concerns over the FDA’s capacity after the layoffs with examples from companies that have already been impacted by the changes at the agency.
The letter, addressed to Senate Health, Education, Labor and Pensions (HELP) Committee Chair Bill Cassidy, M.D., R-Louisiana, is supported by industry heavyweights such as Alnylam’s founding CEO John Maraganore, Ph.D., and Nkarta Therapeutics’ CEO Paul Hastings. The document was sent by No Patient Left Behind, a nonprofit founded by RA Capital’s Peter Kolchinsky, Ph.D., with signatures from other major investors like Sofinnova Investments and The Column Group.
In one case, an FDA dispute resolution process with a Massachusetts biotech was canceled, with an agency counterpart saying there likely wouldn’t be any senior staffers available to review the case.
Another biotech recently received conflicting feedback from a review team, a situation in which a senior official should have determined the agency’s position, according to the letter.
“Critical gaps in leadership and management at the review division level have typically been filled by senior FDA leadership,” the authors write. “But with these individuals now gone, companies fear we are entering a period of years to build back up an experienced workforce.”
The letter also details a biotech receiving submission feedback conducted by a seemingly inexperienced reviewer, including suggestions that don’t align with medical practice or standard approaches to trials.
These scenarios prompted the biotech stakeholders to urge the Senate HELP committee to restore FDA staffing levels in an effort to maintain established regulatory timelines and consistency.
“Specifically, we worry that the institutional knowledge that makes the FDA the world’s leading regulatory body will be irretrievably lost due to the agency’s recent reduction in force and wave of retirements,” the leaders wrote. “The agency’s ability to function is compounded by a hiring freeze. As a result, American patients, American industry and American biomedical leadership will bear the consequences.”
The letter coincides with commentary from Janet Woodcock, M.D., former acting FDA commissioner, who warned that the changes are “a slow-moving catastrophe.”
“You’re not going to see everything come to a stop in the actual review of documents and development programs,” Woodcock said April 7 at the Biopharma Congress event. “But the whole apparatus to get a drug on the market, a lot of that is missing, and you're going to see mistakes.”
In the letter to the Senate, the biotech stakeholders also emphasized the particular importance of a well-staffed FDA for small biotechs. Such companies are tight on resources and depend on investor funding to meet agency requirements, the authors explained. Ambiguity about the FDA's capabilities could trigger downstream uncertainty from investors, the biopharma leaders wrote.
The writers urge the administration to be cautious when attempting to centralize functions and “over-systematize a regulatory process that has to be flexible in the face of new scientific discoveries.”
“Drug development is complex. It's time-consuming; it's resource intensive,” Bicara CEO Claire Mazumdar, Ph.D., told Fierce Biotech last week. Mazumdar also signed the biotech letter to the Senate.
“We as an industry need to work together with the administration, with the regulatory agencies, to really change the landscape for oncology and beyond,” she concluded.