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Drug Development Is Slowing Down After Cuts at the FDA
Agency is missing deadlines and not responding to biotech companies, forcing some to push back clinical trials
By
Jared S. Hopkins
April 17, 2025 5:30 am ET


Biotech companies developing drugs for hard-to-treat diseases and other ailments are being forced to push back clinical trials and drug testing in the wake of mass layoffs at the Food and Drug Administration.

Significant delays in the FDA’s core functions—such as approving amendments to clinical trials and guiding companies through processes for drug approval—are hindering the ability to develop drugs, say industry officials. Those setbacks are contributing to drugs taking longer to get through clinical trials and ultimately reach patients—and straining dollars for testing new possible treatments, say people familiar with the matter.

California-based Daré Bioscience hoped to move forward with a late-stage study this year of a treatment for sexual-arousal disorder in women. But the biotech hit a wall getting the final nod from the FDA on how to measure the study’s goals, and now the company is delaying the start of the study indefinitely, said Chief Executive Sabrina Martucci Johnson.

Twice in the span of two months, the FDA pushed back the date when it would provide guidance for how to measure the study’s goals. Daré Bioscience followed up in March and heard back in April, but the feedback was brief and will require more discussion with the agency before it can move forward with the trial, Martucci Johnson said. In the past, the company has received information about clinical trials and their goals within the planned time frames, she said.

The company is now going to sell the treatment as a compounded drug later this year. It still plans to conduct the trial eventually.

“I know it is a hard time and the system’s under strain, I get it, but we also can’t accept inertia,” Martucci Johnson said. “And if we have another path to make the product available, I think we have to do the right thing.”

The setbacks are the latest ripple effect of Health and Human Services Secretary Robert F. Kennedy Jr.’s aim to reshape the Department of Health and Human Services. About 3,500 workers were cut at the FDA, including Chief Medical Officer Dr. Hilary Marston and Dr. Peter Stein, who oversaw new drug approvals. Top vaccine official Dr. Peter Marks, who oversaw vaccines and biologics, was also cut.

“FDA is actively working to ensure continuity of operations during the reorganization period and remains committed to ensuring critical programs and testing continue,” said an agency spokeswoman.

Both large and small drugmakers rely heavily on the FDA before and after drugs hit the market, from ensuring safe laboratory and animal testing leading up to approval, to monitoring safety once drugs hit pharmacy shelves. Drug development is risky, with most drugs failing in testing, making regulators crucial parties, say regulatory experts and industry officials.

But the biotech industry is particularly vulnerable to agency slowdowns. The sector has been a bleak and challenging market for several years. Companies have filed for bankruptcy, shelved drug programs and companies that went public in recent years have been unable to raise capital. Regulatory hurdles can hurt drugmakers’ pocketbooks even more because the testing and approval process can cost hundreds of millions of dollars.

Large companies generate billions in annual sales from approved drugs, while smaller biotechs might develop as little as one drug. Their success and investors’ support hinges on regulatory milestones, making every interaction with the FDA key.

At one biotech preparing to test an experimental cancer antibody, the company’s request to have study subjects provide a second biopsy was denied by the FDA, according to a person familiar with the matter.

The company has conducted trials for other drugs in which subjects get two biopsies, and European regulators approved it for this trial. A second biopsy in the U.S. trial would have allowed the company to measure how tumors change over time and regulators increasingly allow them in trials, the person said.

In denying the company, the FDA first cited agency guidance that was drafted but not yet adopted, which said the biopsy could only be a secondary goal of the trial, the person said. When the company responded by agreeing to make it a secondary goal, the FDA then said no because there wouldn’t be a benefit to the patient, the person said.

The denials, the agency’s reasoning and the speed at which the subsequent denial was issued—a few hours—makes the company suspect a less-experienced staffer was overseeing the process, the person said. The company could have appealed but that would have meant delaying its early-stage study, the person said.

It is rare for the FDA to stray from deadlines, not respond to companies in timely manners or give feedback that leaves companies confused—measures that were set up years ago to address bottlenecks at the time, said Marc Scheineson, a former FDA associate commissioner.

Some programs were set up with fees from the industry to ensure timely decisions, and agency performance is typically taken seriously, and reported to Congress with reports posted online, he said.

“When you cut the administrative staff and you still have these product deadlines, you’re creating an unwinnable situation,” he said. The worst thing for companies isn’t 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,” Scheineson said.

For another biotech testing a treatment for a life-threatening genetic respiratory disease, the FDA never responded to its query. In March, the company asked to amend a trial set for later this year by allowing study participants to take steroids to help with possible side effects, according to a person familiar with the matter. The FDA still hasn’t responded to the request, which would normally get resolved within a few days, the person said.

The company is now looking to shift its focus on making changes to its sites in Europe, the person said. The company still plans to start the U.S. trial but might delay the program depending on when the FDA clears the amendment, the person added.

Many in the industry have taken notice of the latest setbacks. Dozens of executives, patient advocates and investors last week sent a letter to Sen. Bill Cassidy (R., La.) asking him to “identify where FDA’s capabilities have been impacted in order to quickly preserve and restore its core functions.” Cassidy chairs the Health, Education, Labor and Pensions Committee, which approved the nomination of new FDA Commissioner Marty Makary. The letter was sent by No Patient Left Behind, an advocacy group founded by Peter Kolchinsky of RA Capital, a health investor.

John Maraganore, a former chief executive of Alnylam Pharmaceuticals, who advises companies as a venture capitalist, said the cuts to the FDA and latest regulatory hurdles will require Makary to rebuild the agency with talented people.

“It is a rebooting of the FDA in a significant way and the hope is he can find the right talent, but it isn’t easy,” he said.


Link: WSJ