Woodcock Asks for OIG Review of Alzheimer’s Approval
FDA acting commissioner Janet Woodcock is distancing herself further from the controversial approval of Biogen’s Alzheimer’s therapy Aduhelm (aducanumab-avwa), asking the HHS inspector general to “conduct an independent review and assessment of interactions between representatives of Biogen and FDA during the process that led to the approval of Aduhelm.” When the therapy’s approval was announced last month, several agency releases justifying the approval were noticeably absent any mention of Woodcock’s position.
In a 7/9 letter posted on Twitter, Woodcock said: “We believe an independent assessment is the best manner in which to determine whether any interactions that occurred between the manufacturer and the agency’s review staff were inconsistent with FDA’s policies and procedures.”
The Biogen approval has been met with growing criticism. Earlier this week, FDA approved a narrower product label to limit its indication and usage to disease stages studied in the supporting clinical trials. When the drug was approved last month, critics immediately questioned why FDA approved a broad label for use by any patient with Alzheimer’s despite trial data not showing effectiveness in early- or late-stage patients (see earlier story).
Additionally, despite Woodcock’s name not being directly attached to Biogen’s approval, stakeholders and some on Capitol Hill have criticized Woodcock’s oversight. The controversial decision to provide accelerated approval illustrates the need to disrupt the status quo at FDA and nominate someone other than acting commissioner Janet Woodcock, Senator Joe Manchin (D-WV) said in a 6/17 letter to President Biden. Noting the scientific community’s uproar second-guessing the drug’s benefits and the resignations of three advisory committee experts (see story) in protest over the approval, Manchin said “(h)aving a permanent agency head in charge to answer patients and doctors questions on this approval, as well as assure the general public ofthe FDA’s commitment to public health, is imperative, and Dr. Woodcock is not the right person to lead the FDA. This approval underscores the fact that more of the same leadership at the agency is not the answer.”
And Public Citizen has called for Woodcock, CDER director Patrizia Cavazzoni, and CDER Office of Neuroscience director Billy Dunn to resign or be dismissed over what the advocacy group calls the “reckless approval of aducanumab for Alzheimer’s.” A Public Citizen statement late last month questioned new disclosures in a detailed exposé published by STAT about how Biogen used an FDA back channel to win approval for aducanumab. “The circumstances described in the STAT exposé, if confirmed, paint a damning picture of drug regulators who surrendered their independence and objectivity, essentially began working on behalf of Biogen, and fostered regulatory capture at the agency,” the advocacy group said.