New FDA turmoil throws agency's reliability into question

Text messages from current FDA staffers shared confidentially with Axios show people disturbed by the turmoil and increasingly motivated to leave the agency — a threat heightened by how many experienced career officials have already left.

• "If they could get enough money elsewhere, if they could get remote jobs, if they could get as much vacation, they would just leave," a former FDA staffer told Axios, speaking of current staffers.
• "I don't know that I've talked to anyone who's happy there."

Driving the news: The agency's top drug regulator resigned over the weekend amid a lawsuit alleging he used his position to get revenge against a former business associate.

• The official, George Tidmarsh, denied the allegations and told The New York Times he believed he was being retaliated against for raising concerns with a new agency program to speed certain drug approvals.
• He told Endpoints News he'll fight his ouster.

Between the lines: "Good people leave and the other problem is, because of all of this perceived chaos, it becomes even harder for the FDA to recruit new employees," said Peter Pitts, a former associate FDA commissioner and president of the Center for Medicine in the Public Interest. "And it's never been easy."

• The upheaval came on the heels of explosive reporting about the agency's biologics and vaccines regulatory arm, with Stat writing that the division has become "rife with mistrust and paranoia" under the leadership of Vinay Prasad.
• Prasad made headlines earlier this year when he left the agency under criticism from right-wing activist Laura Loomer, only to return a couple of weeks later.

The big picture: The pharmaceutical and biotech industry depend on the agency being predictable and reliable to shepherd millions of dollars in investments.

• "When pharmaceutical companies on their own or smaller companies with their venture capital partners see that you can't predict what the FDA is going to do from day to day, they simply take their investment dollars and place them elsewhere," Pitts said.
• The latest turmoil comes on top of the agency facing thousands of layoffs earlier this year as part of the Trump administration's downsizing of the federal government.

Where it stands: Even before the latest drama, Raymond James analysts wrote in a note in mid-October that the FDA's 32 drug approvals so far this year are a "bit behind" the rate from 2023 and 2024.

• "Eventually the staffing shortfalls will lead to significant challenges for companies pursuing FDA approvals," the analysis stated. "FDA will likely face a choice of dramatically slowing the approval process, or decreasing thoroughness of reviews, which could endanger the public."
• A recent RBC Capital Markets analysis found that third-quarter FDA approval rates dropped while rejections and review delays rose.

The other side: "The FDA continues to carry out its mission to protect public health with the same rigor and independence the American people expect," said Health and Human Services spokesperson Emily Hilliard.

• "The agency's work to review and approve safe and effective medical products remains fully operational and guided by science, not politics."

The bottom line: There's already concern about what effect the Trump administration will have on the nation's standing as the world leader in biopharmaceutical innovation.

• Its hostility toward pharmaceutical companies, hollowing out of the federal workforce and cancellation of federal research dollars have all rung alarm bells throughout the research and development pipeline.
• How much companies and investors will tolerate an underperforming and dysfunctional FDA — and for how long — before looking to other markets remains a key question.