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# Woodcock ‘Unfit’ to be CDER Director: Public Citizen
- URL: https://www.fdaweb.com/woodcock-unfit-to-be-cder-director-public-citizen/
- Published: 2016-10-03T12:00:00.000Z
- Updated: 2026-09-14T21:36:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136973

CDER director **Janet Woodcock** is “unfit to serve as CDER director,” Public Citizen Health Research Group director **Michael Carome** says in a *Huffington Post* blog [posting](http://www.huffingtonpost.com/michael-carome-md/outrage-of-the-month-fda%5Fb%5F12314644.html??ref=fdaweb.com). Her decision last month to approve Sarepta’s Duchenne muscular dystrophy drug eteplirsen while overruling several agency experts, “represents a dangerous, unparalled capitulation to pressure from politicians and patients and a stunning disregard of the scientific evidence,” Carome writes. “Her action eviscerates the FDA’s long-standing (but, under Woodcock, already declining) approval standards for new drugs, threatens public health....”

Carome’s post noted concerns from CDER Office of Drug Evaluation 1 director **Ellis Unger** about Woodcock’s involvement in the submission and his appeal to have her decision examined by FDA commissioner **Robert Califf** ([see story](https://www.fdaweb.com/woodcock-wanted-drug-approved-before-review-completed-fda-records/)). Unger [characterized](http://www.citizen.org/documents/UngerAppealMemoEteplirsen.pdf?ref=fdaweb.com) Woodcock’s involvement in the review of eteplirsen as “unprecedented,” including her extensive involvement in the planning of, and her participation in, a 4/25 advisory committee meeting. Unger also raised concerns about Woodcock’s issuance of her decision memo before he had finished his own decision memo on behalf of the team of FDA scientists who had conducted the review of the drug.