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# Public Citizen Blasts Potential Drug Approval Change
- URL: https://www.fdaweb.com/public-citizen-blasts-potential-drug-approval-change/
- Published: 2024-11-07T12:00:00.000Z
- Updated: 2026-09-14T14:46:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158139

Public Citizen says a potential legislative initiative expected to be advanced in 2025 would be dangerous in exempting rare disease drugs from the requirement to be subject to randomized trials. In a [statement](https://www.citizen.org/news/dangerous-proposal-would-exempt-rare-disease-drugs-from-fda-randomized-trial-requirement/?ref=fdaweb.com), Public Citizen says the proposal is being developed by retired FDA CDER director, acting commissioner, and principal deputy commissioner **Janet Woodcock**, who is collaborating with the Haystack Project, which Public Citizen describes as a “rare disease non-profit organization that partners with Big Pharma.”

According to Public Citizen Health Research Group director **Robert Steinbrook**, the proposal would allow drugs indicated to treat rare diseases to be approved based on substantial evidence of effectiveness rather than clinical trials.

“The proposal threatens to undermine the drug review and approval process and, by extension, could endanger patients,” he said. “Although FDA has erred on specific decisions, such as the recent approval of new drugs for Alzheimer’s disease, the agency already has ample authorities and flexibilities to consider drugs, including those for rare diseases, within its existing regulatory structure. The focus of researchers and industry should be on developing better drugs for rare diseases, not changing or weakening FDA’s approval standards.”