> ## 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.

# Woodcock Rejects Public Citizen ‘Firewall’ Proposal
- URL: https://www.fdaweb.com/woodcock-rejects-public-citizen-firewall-proposal/
- Published: 2021-02-17T12:00:00.000Z
- Updated: 2026-09-14T16:47:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148683

FDA acting commissioner **Janet Woodcock** says a Public Citizen proposal to create a “firewall” between agency staff involved in any pre-submission interactions with drug sponsors and FDA staff involved in post-submission NDA or BLA review and decision-making “would cause significant repercussions for public health.” She commented in a 2/11 [letter](http://freepdfhosting.com/5e45ef33f2.pdf?ref=fdaweb.com) to Public Citizen in response to the advocacy group’s concerns about FDA’s review of a Biogen BLA for aducanumab, intended to treat Alzheimer’s disease.

Public Citizen has [asked](https://www.fdaweb.com/investigate-fda-role-with-biogen-on-alzheimers-drug-public-citizen/) the HHS inspector general to “investigate the unprecedented and inappropriate close collaboration between FDA and Biogen regarding the company’s application for approval of the Alzheimer’s drug aducanumab.” In its letter to HHS, Public Citizen says that after two identical Phase 3 trials of the drug were stopped at the halfway point because a preliminary analysis found that they were unlikely to show the drug benefited Alzheimer’s patients, FDA and Biogen worked collaboratively to salvage the drug.

“They jointly relied on dubious analyses that over-emphasized the results of one Phase 3 trial suggesting the drug may work at a high dose, but disregarded data from the other Phase 3 trial showing no benefit of the drug at any dose,” Public Citizen said. “FDA and Biogen coauthored an unprecedented joint briefing document … that was heavily biased in favor of the drug.”

An FDA advisory committee [voted](https://www.fdaweb.com/panel-thumbs-down-on-biogen-alzheimers-drug/) 8-1 on 11/9/20 that the Biogen study did not provide strong evidence of the drug’s effectiveness. Earlier this year, FDA extended by three months to 6/7 the user fee action date on the BLA. The agency [said](https://www.fdaweb.com/biogen-alzheimers-bla-review-extended/) the extension was triggered by a Biogen-submitted information request response that included FDA-requested analyses and clinical data.

In her response to Public Citizen, Woodcock said FDA took the group’s charges seriously and will continue to consider the issues, as well as fully cooperating if the inspector general decides to investigate.

On the notion of a firewall, she said that Public Citizen was overlooking the fact that FDA interactions with sponsors are critically important to drug development. “Drug development is a highly complex process and FDA’s interactions with sponsors are essential to set clear goals and expectations,” she wrote. “In an increasingly scientifically complex landscape, the absence of these interactions would dramatically delay the availability of effective drugs for patients who need them.”

Woodcock also said a firewall is not necessary to ensure the integrity of agency decision-making. She said the agency has a long history of conducting its scientific and regulatory processes, including reviews of investigational new drug applications and NDAs/BLAs, with integrity, focusing on public health considerations and ensuring independence and scientific excellence as cornerstones of its work.