Michael Harrop
Well-known member
https://www.nytimes.com/2025/07/08/magazine/fda-collapse-rfk-kennedy.html
Includes some comments by the former FDA commissioner, Robert Califf. And ends with:
Includes some comments by the former FDA commissioner, Robert Califf. And ends with:
“History will see this as a huge mistake,” he mused. “The F.D.A. as we’ve known it is finished.”
We want protection from bad food and bad medicine and other unsafe products, but we also want to draw the line between safe and unsafe for ourselves and to redraw it whenever we see fit. The F.D.A. has always reflected this tension.
the agency itself is profoundly under-resourced.
The F.D.A. receives less money from Congress than any of its sibling institutions, including the Centers for Disease Control and Prevention and the National Institutes of Health. In fact, its federal budget is roughly the size of the budget of the local school district in Montgomery County, Md., where it is based. Its infrastructure is wildly inadequate: fax machines, clunky computer systems, warehouses full of paper records that should long since have been digitized. And its staff members are poorly paid and frequently outgunned by the companies they are charged with regulating.
One perfect example of this dynamic involved the food and beverage industry, which Kennedy was so fond of calling out
Like almost all its biggest challenges, the trouble boiled down to two things: The F.D.A. needed more money, and the F.D.A. needed more authority. Both were on Congress to provide, but lawmakers had a habit of heaping mandates on the agency without addressing either issue — and then heaping blame on regulators for every failure that resulted.
NYT's article title is blaming RFK for cuts he wasn't responsible for. As far as I know, it was DOGE and the Office of Management and Budget (OMB) that were responsible for the cuts.Jones’s team had just finished revamping the F.D.A.’s Human Foods Program, the largest reorganization in the agency’s long history. And the changes they had implemented, and the ones they were still working on, were all in line with Kennedy’s stated goals.
In Jones’s department, the people fired were the ones most needed for the things the health secretary had said he hoped to focus on.
‘What you see over time is that industry’s priorities become agency priorities.’
Something I've also complained about for many years.In “Doctored,” a book about the quest to cure Alzheimer’s, published this year, Charles Piller details how the agency failed to properly police clinical trials for safety or fraud.
A couple of weeks later, Kennedy made his first in-person visit to FDA headquarters. In a speech broadcast from a private room to a large hall where the agency’s staff had gathered, he doubled down on the sentiments expressed in his October post. The Deep State was real, he said. And the F.D.A. was a mere industry “sock puppet.”
At first blush, Kennedy’s remarks appeared to dovetail with the critiques leveled by experts like Ramachandran. So many of the F.D.A.’s missteps seemed — to both agency watchdogs and the MAHA faithful — to come down to the undue influence of industry over the institution.
But where Kennedy and his ilk saw conspiracy or corruption, Ramachandran and other watchdogs saw something far more complicated. For one thing, it was not just the agency that had been captured by industry. Congress, doctors, patient-advocacy groups and a regulation-wary public had all played a role in weakening the F.D.A.
For another, those who had served on both sides of the watchdog-regulator divide knew firsthand how mission-driven most of the agency’s rank and file were and how irrelevant political considerations were to their actual work.
Everyone, regardless of whom they represented (industry, patients, doctors, consumers), hated the F.D.A. And different organizations often had the exact opposite idea of what regulators were doing wrong and why. If one group said that the agency was too slow or that people were dying for want of cures while bureaucrats dotted I’s and crossed T’s, the next would accuse them of rushing products to market without sufficient regard for safety or effectiveness.
In June, Makary and his deputies began a six-city listening tour with drug-industry executives that was, despite all the talk of radical transparency, closed to the public. Later that month, Makary announced a voucher program that would shorten drug review times from 10 to 12 months to just one or two for companies whose products met certain criteria.
He also laid out a new list of agency priorities in The Journal of the American Medical Association that, for drugs, seemed to come down to two things: faster reviews and more approvals. “Their paper reads like it’s straight from pharma’s playbook,” Ramachandran told me. “They criticized expedited drug reviews for years, especially with respect to Covid vaccines, saying that it turned the F.D.A. into a rubber stamp. But now they want to do the exact same thing for as many other drugs as possible.”
- Format correct?
- Yes