HHS OIG to review FDA’s use of accelerated approval pathway

Regulatory NewsRegulatory News
| 04 August 2021 | By Michael Mezher 

In the wake of the US Food and Drug Administration’s (FDA) controversial decision to grant accelerated approval to Biogen’s Alzheimer’s drug Aduhelm (aducanumab), the US Department of Health and Human Services’ Office of Inspector General (OIG) announced it will conduct a review of the agency’s policies and procedures related to the pathway.
“The FDA's approval of Aduhelm raised concerns due to alleged scientific disputes within the FDA, the advisory committee's vote against approval, allegations of an inappropriately close relationship between the FDA and the industry, and the FDA's use of the accelerated approval pathway,” the OIG wrote in its announcement of the review on Wednesday. (RELATED: Adcomm gives big thumbs down to aducanumab, Regulatory Focus 6 November 2020; FDA approves aducanumab for use in Alzheimer’s disease, Regulatory Focus 7 June 2021)
The review, which HHS OIG says is expected sometime in FY2023, comes amid criticism of the agency over the decision, a separate investigation by the House Oversight and Reform Committee and Energy and Commerce Committee, and FDA’s own review of whether certain oncology indications with accelerated approval should remain on the market after confirmatory trials failed to verify their clinical benefit. (RELATED: Industry-wide accelerated approval review yields four withdrawals, Regulatory Focus 10 March 2021)
Notably, OIG says it will not “assess the scientific appropriateness” of FDA’s approval decisions but suggested the review may yield multiple reports.
The announcement of the review follows a request by FDA Acting Commissioner Janet Woodcock to Acting Inspector General Christi Grimm to conduct an independent review “of interactions between representatives of Biogen and the FDA during the process leading to the decision to approve the [biologics license application] BLA to determine whether any of those interactions were inconsistent with FDA policies and procedures.” (RELATED: Woodcock calls for investigation into Aduhelm approval, Regulatory Focus 9 July 2021; FDA defends Aduhelm's accelerated approval, while others call for reform, Regulatory Focus 14 July 2021)
At the time, Woodcock defended the integrity of staff and leadership at FDA’s Center for Drug Evaluation and Research but acknowledged that some contacts between Biogen and FDA staff “may have occurred outside of the formal correspondence process.”
The health news outlet STAT reported in late June that Biogen had used “an FDA back channel” to aid in securing accelerated approval of the drug. In addition to reporting that back-channel meetings had occurred, STAT also reported that internal meeting minutes dating to June 2019 contained discussion of an accelerated approval pathway for Aduhelm – an option not put before the Peripheral and Central Nervous System (PCNS) drugs advisory committee at the November 2020 meeting that reviewed Aduhelm.
However, the review announced by the HHS OIG will span beyond FDA’s actions related to Aduhelm. “We will review the FDA’s relevant policies and procedures, determine compliance with them, and make appropriate findings and recommendations based on a sample of drugs approved using the accelerated approval pathway, which will include Aduhelm,” OIG wrote.
“The FDA intends to fully cooperate with the HHS OIG review and welcomes the opportunity to provide clarity regarding the science-based application of the accelerated approval pathway,” Woodcock tweeted. “Should the HHS OIG identify any actionable items and provide the agency with recommendations, the FDA would review those expeditiously to determine the best course of action.”


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