Is Vinay Prasad Undermining President Trump's Agenda?
Sensing the Civil War was nigh, President Lincoln famously said "A house divided cannot stand.” (He was actually quoting the Bible, but Lincoln popularized the phrase.)
It was true then and is now.
As we enter the second year of the Trump administration, the divided house at the Food and Drug Administration is struggling to stay up.
Perhaps it's time for some changes.
Driving the division at the FDA: Someone on the far-left who, it can be argued, can't be described as supportive of the president's agenda.
Concurrently, perceptible chaos is emergent.
The cause may be traced directly to Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER).
Thanks to the efforts of FDA gadfly Lizzy Law that he's a horrible micro-manager as well. She recently tweeted:
A tidbit in a recent STAT's DC Diagnosis newsletter: Vinay Prasad wants access to FDA employees' calendars, though his own is largely private. He has also instructed employees not to tell their supervisors when he reaches out to schedule meetings.
After being appointed last May as the CBER director, Prasad quickly alienated his team as the department became "rife with mistrust and paranoia" and staff were "terrified of pushing back on Prasad, lest they face retaliation."
Late last year, Dr. Richard Pazdur resigned from the FDA, after 30 years of service as one of the most respected leaders in cancer research. He was appointed to the Oncology Center of Excellence to stabilize the agency's Center for Drug Evaluation and Research (CDER), but resigned after just three weeks there.
Prasad's management style has reportedly been pointed to as the culprit for Pazdur's and others' leaving.
Faced with mounting resignations, Prasad reportedly tried to stem the bleeding by blocking transfers, effectively trapping unhappy employees.
Some CBER staff were so fed up they sought to transfer to CDER – yes, we know all these acronyms are difficult to keep track of – only to have Prasad intervene to prevent it, apparently aware that his division "can’t afford to lose many more employees."
Does Prasad belong in a Republican administration?
He's an outspoken pro-abortion rights advocate who describes himself as a Sanders/Warren progressive.
His appointment to CBER overseeing drug development affecting pregnant women and unborn children was seen as a "direct threat to the culture of life," given Prasad's philosophy that the act of abortion qualifies as "healthcare."
He has praised the permissive framework of Roe v. Wade, 410 U.S. 113 (1973), describing abortion access as an essential "right."
While Prasad has made himself an easy target, much of the blame for chaos at the FDA is directed at Marty Makary, its commissioner. In the months following his appointment, many veteran FDA leaders were forced out, leaving only a few long-time officials in place.
This gutting of experienced staff is not good.
The agency has suffered internal scandals, forced staff resignations, horrible morale, and record staff departures.
One imagines a lot of these problems could be fixed if Makary just fired Prasad.
Conservatives often like to rail against the federal government because of this level of dysfunction. But we do actually need the government to do its job.
As far as the FDA is concerned, it has the incredible mission of approving life-saving and life-improving new medicines, which is seemingly not happening in the current environment.
Biotech companies report new difficulties in scheduling meetings and adhering to approval timelines due to staff shortages.
This has already led to delays in drug development milestones, and some companies even whispering they need to offshore drug-development to other countries.
Shares of some biotech firms have declined sharply due to investor concerns over regulatory uncertainty .
Significant delays in the FDA's core functions, such as approving amendments to clinical trials and guiding companies through processes for drug approval, hinder the ability to develop drugs.
Recall, the clinical trial process is long, onerous, and difficult already let alone when there's chaos at the FDA purportedly reigns.
The gaps created by the mass exodus at the FDA staff could take years to rebuild.
Meanwhile, under Makary, the FDA has recently approved generic over-the-counter mifepristone.
Although the drug had been in limbo under the Biden administration, it was quickly approved under Makary’s leadership.
Makary has signaled that the safety review for mifepristone has been delayed until after the 2026 midterm elections so that elections don't fixate on abortion as an issue, but those of us who want to take this as a win still can.
The president has made huge (dare we say "yuge") promises in American medicine: faster approvals of new drugs, more cures, and lower prices for the end-user, all while maintaining America's biotech leadership for the future.
He can certainly deliver this, but not until he cleans the divided house of the FDA.
Jared Whitley is a longtime politico who has worked in the U.S. Senate, White House, and defense industry, and has an MBA from Hult Business School in Dubai. Read more Jared Whitley Insider articles. Click Here Now More Here.
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