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# 4 Major Issues ‘Plaguing’ FDA: Newsweek
- URL: https://www.fdaweb.com/4-major-issues-plaguing-fda-newsweek/
- Published: 2026-03-11T12:00:00.000Z
- Updated: 2026-09-14T13:35:18.000Z
- Author: David McFarland
- Tags: FDA Policy/General, Drugs, #legacy-id-D5160804

*Newsweek* says FDA “has faced an unusual convergence of political, scientific, legal and operational pressure in recent months, as it balances public health demands with intensifying scrutiny from the White House, Congress, industry and patient advocates.” The magazine details four major issues that it says have plagued the agency in the past year:

- **Using leucovorin to treat autism** – FDA commissioner **Marty Makary** said at a 9/2025 White House event that leucovorin (folic acid) could have a potential benefit to treat “hundreds of thousands of kids” with autism. Health experts and autism advocates raised concerns about his statements, saying the process departed from the agency’s typical approach and that evidence of effectiveness remains limited. On 3/10, FDA approved leucovorin not for an autism indication, but to treat cerebral folate deficiency, a rare genetic disorder. Senior agency officials told the news media that after reviewing the strongest evidence, research only supported the drug’s use by patients with the rare mutation that affects folate levels in the brain.
- **Leadership upheaval and workforce pressures** – The magazine reviews the resignation of former CBER director **Peter Marks**, saying he was given a choice of resigning or being fired by HHS secretary **Robert F. Kennedy Jr**. In a letter to acting commissioner **Sara Brenner**, Marks said, “It has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies.” *Newsweek* reports that Marks’ resignation alarmed lawmakers and industry leaders who were concerned about a broader overload of vaccine policy without Marks being in charge. The article also references the agency restructuring that reduced FDA staff by 3,500 positions, with experts warning that the move would clearly affect the agency’s ability to review and approve products.
- **The commissioner’s national priority voucher program** – The article says that health policy experts and FDA veterans have warned that aggressively shortening review times risks undermining the scientific rigor that underpins drug safety decisions.
- **Drug shortages and rejections** – *Newsweek* cites a *ProPublica* report that found that FDA allowed certain drugs from factories under import bans to continue to enter the U.S. due to concerns about medication shortages. Another issue it cites is that rare disease patients and advocates have been calling for more treatments to be made available, while FDA has been rejecting treatments for these conditions. Rather, it says, the agency has been advising manufacturers to launch expensive and time-consuming studies into the treatments, delaying approval by years, for drugs aimed at patients with life-threatening conditions that often have no approved cure. “This has prompted notable backlash,” the article says, “as Sen. **Ron Johnson** (R-WI) has said he will be launching an investigation into FDA because of the treatment denials.”

“Together,” the article concludes, “the disputes have placed FDA in an unusually fraught position, forced to defend its scientific standards even as it faces mounting political pressure to move faster, approve more treatments, and align more closely with White House priorities. How the agency navigates these demands may shape public trust in federal health regulation long after the current controversies subside.”

An HHS spokesman told *Newsweek*, “FDA continues to apply the same high standard to all drugs and therapies, requiring clear evidence of clinical benefit for the American public. No FDA in history has produced as much positive regulatory change in such a short span as commissioner Makary’s FDA. The American people voted for an FDA that works for them, not the industry, and the agency is delivering by refusing to rubber-stamp approvals.”