> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Tumult Keeps Makary Under Microscope: NYT Article
- URL: https://www.fdaweb.com/fda-tumult-keeps-makary-under-microscope-nyt-article/
- Published: 2025-12-19T12:00:00.000Z
- Updated: 2026-09-14T15:29:43.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5160418

Turmoil at FDA has increasingly placed commissioner Marty Makary under the microscope after senior staff departures, internal disputes and controversial policy decisions ripple through the agency, raising concerns among public health experts and the biotech industry. The *New York Times* [reports](https://www.nytimes.com/2025/12/19/health/fda-marty-makary-kennedy.html?ref=fdaweb.com) that the leadership strain spilled into the White House earlier this month after the resignation of CDER director **George Tidmarsh**, following allegations that he had misused his authority to retaliate against a former business associate ([see story](https://www.fdaweb.com/top-drug-chief-resigns-amid-misconduct-probe-lawsuit/)). HHS secretary **Robert F. Kennedy Jr.** and senior aides, including deputy secretary **Jim O’Neill**, raised concerns about FDA’s management in meetings with top aides to President Trump, according to people familiar with the discussions.

Those meetings were widely seen as targeting Makary, but the White House ultimately rebuffed the effort, signaling continued support for Makary and producing what officials described as a fragile truce, according to the *Times*. A White House spokesman said the administration has “complete confidence” in Makary and the leadership of FDA and HHS.

The episode has underscored broader instability at the FDA, which has lost roughly 4,000 employees — about 20% of its workforce — this year through layoffs, buyouts and resignations. Internal documents reviewed by the *Times* show staffing levels in the drug division have fallen back to where they were nearly a decade ago, eroding inspection capacity and scientific review at an agency that regulates products accounting for about one-fifth of U.S. consumer spending.

Biotechnology companies and investors have increasingly pressed FDA and the White House over a series of drug rejections and reversals, particularly for treatments targeting rare diseases. Several of those decisions were driven by the agency’s chief scientific and medical officer **Vinay Prasad** overruling staff recommendations, fueling claims of politicization, according to the *Times*.

Leadership turnover has also compounded the unease. Tidmarsh’s resignation was followed by the short-lived appointment of longtime oncology chief **Rick Pazdur** to oversee the broader unit. Pazdur retired less than three weeks later, citing management tensions, prompting warnings from industry leaders that the agency was nearing a “tipping point.”

Makary moved quickly to name a successor, but critics say the repeated shakeups, combined with workforce losses and policy whiplash, have weakened confidence in the agency’s ability to carry out its core mission, the *Times* reports.

Former FDA commissioner **Robert Califf** said the recent turmoil reflects a deeper shift away from the agency’s tradition of insulating scientific decisions from politics. “One of the concerns overall is that more and more decision-making is in the hands of people influenced by politics,” Califf said.