Congressional Probe Confirms Inappropriate FDA-Biogen Collaboration

A scathing report issued by the U.S. House of Representatives’ Committees on Oversight and Reform and on Energy and Commerce on Dec. 29, 2022, affirmed allegations raised by Public Citizen’s Health Research Group two years earlier about the inappropriately close collaboration between drugmaker Biogen and the Food and Drug Administration (FDA) during the analysis of data from the key clinical trials of the Alzheimer’s disease drug aducanumab (ADUHELM).[1]

In one of the worst decisions in its history, the FDA in June 2021 approved aducanumab for the treatment of Alzheimer’s disease.[2] The FDA took this action despite the nearly unanimous conclusion of an advisory committee convened by the agency in November 2020 that there was inadequate evidence that the drug is effective for slowing cognitive decline in patients with Alzheimer’s disease.[3]

In December 2020 and June 2021, Public Citizen urged the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) to investigate the unprecedented and inappropriately close collaboration between Biogen and the FDA.[4],[5] This close collaboration before and after the submission of the company’s marketing application for aducanumab dangerously compromised the integrity of the FDA’s review and decision-making for the drug. An OIG investigation into this matter was finally initiated in August 2021 and is ongoing.[6]

Separately, the House Committees on Oversight and Reform and on Energy and Commerce in June 2021 launched a joint investigation into the FDA’s review and approval of aducanumab.[7] According to their December 2022 report, the committees found that the FDA’s approval process for aducanumab was “rife with irregularities.”[8]

The House committees’ review of more than 500,000 FDA and Biogen documents disturbingly revealed that agency staff and the drugmaker engaged in at least 115 meetings, calls and substantive email exchanges — including at least 40 FDA-Biogen “working group” meetings — over a one-year period starting in July 2019.[9] The FDA’s own internal review characterized the extent of collaboration between the FDA and Biogen as “atypical” and “exceed[ing] the norms in some respects.”[10]

The House committees also found that the FDA and Biogen inappropriately collaborated in the preparation of a joint briefing document for the November 2020 FDA advisory committee meeting.[11] For example, the FDA provided direct guidance to Biogen on drafting the company’s own sections of the briefing document.

Predictably, the FDA’s own internal review concluded that the agency’s interactions with Biogen prior to the company’s submission of the marketing application for aducanumab were “appropriate,”[12] which highlights the fact that the agency is incapable of objectively investigating its own misconduct. Public trust in the FDA can only be restored by firing the senior FDA officials who have fostered a culture that encouraged the inappropriately close collaboration between the agency and Biogen and undermined the integrity of the agency’s drug review process.
 

References

[1] Johnson M. House investigation faults FDA, Biogen for Alzheimer’s drug approval. The Washington Post. December 29, 2022. https://www.washingtonpost.com/science/2022/12/29/alzheimers-fda-biogen-aduhelm/. Accessed January 9, 2023.

[2] Food and Drug Administration. FDA’s Decision to Approve New Treatment for Alzheimer’s Disease. June 7, 2021. https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease. Accessed January 6, 2023.

[3] Food and Drug Administration. Final summary minutes of the Peripheral and Central Nervous System Drugs Advisory Committee meeting. November 6, 2020. https://www.fda.gov/media/145690/download. Accessed January 6, 2023.

[4] Public Citizen. Letter to the Department of Health and Human Services’ Office of Inspector General requesting an investigation of the Food and Drug Administration’s inappropriate close collaboration with Biogen before and after the submission of the biologics license application for aducanumab for treatment of Alzheimer’s disease. December 9, 2021. https://www.citizen.org/wp-content/uploads/2560.pdf. Accessed January 6, 2023.

[5] Public Citizen. Letter to the Department of Health and Human Services’ Office of Inspector General reiterating request for an investigation of the Food and Drug Administration’s inappropriate close collaboration with Biogen before and after the submission of the biologics license application for aducanumab for treatment of Alzheimer’s disease. https://www.citizen.org/wp-content/uploads/2592.pdf. Accessed January 6, 2023.

[6] U.S. Department of Health and Human Services. Office of Inspector General. Review of the FDA's accelerated approval pathway. https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000608.asp. Accessed January 6, 2023.

[7] Higgins-Dunn N. Congressional Democrats launch probe into Biogen's Aduhelm FDA approval, citing 'serious concerns.' FiercePharma. June 25, 2021. https://www.fiercepharma.com/pharma/we-have-serious-concerns-congressional-democrats-launch-probe-into-approval-pricing-for. Accessed January 6, 2023.

[8] U.S. House of Representatives. Committee on Oversight and Reform and Committee on Energy and Commerce. The High Price of Aduhelm’s Approval: An Investigation into FDA’s Atypical Review Process and Biogen’s Aggressive Launch Plans. December 2022. https://democrats-energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/Final%20Aduhelm%20Report_12.29.22.pdf. Accessed January 10, 2023.

[9] Ibid.

[10] Ibid.

[11] Ibid.

[12] Ibid.