Janet Woodcock, acting head of the Food and Drug Administration, has endured mounting criticism for her role as overseer in the agency’s decision to approve a controversial Alzheimer’s treatment despite dubious scientific backing, with some consumer advocates saying she should be skipped for the permanent post.
“I think it certainly endangers her potential nomination … and now, we think she should be removed from her acting position because of the decision to approve [the Alzheimer’s treatment] aducanumab,” said Michael Carome, director of health research at the liberal watchdog group Public Citizen.
Woodcock looks to be the favorite to head up the FDA given her decades of experience as a government health official, though President Joe Biden has not yet nominated an expert to take the job permanently. Her reputation among some patient advocates has suffered since the agency went against the counsel of its panel of neuroscientists and approved a monthly IV treatment for patients with mild Alzheimer’s symptoms that have not proven to be highly effective at slowing cognitive decline.
“It’s really eviscerated the agency’s science standards for approving research and flies in the face of science-based decision-making, and it has really weakened the FDA’s standing,” Carome said.
Some members of Congress have also expressed misgivings about Woodcock’s potential promotion to lead the agency. West Virginia Democrat Joe Manchin, for instance, pressured Biden to consider another candidate last month, arguing that Woodcock oversaw the approval of highly addictive opioids starting with OxyContin in 1995 and did nothing to keep the drugs from entering the market. Manchin said that the FDA has played a “critical role” in fueling the opioid epidemic and that “Dr. Woodcock has been there for all of it.”
Public Citizen has mounted pressure on Woodcock since she took the FDA post in January to disclose the nature of her ties to the pharmaceutical industry, which the group argued has given opioid manufacturers and other drugmakers a leg up in the process to obtain regulatory approval for products. Those close ties were a means for the biotech company Biogen, the maker of aducanumab, to carve out a path to approval with help from an agency insider — Billy Dunn, head of the office of neuroscience at the FDA — according to Public Citizen.
Woodcock defended the agency’s decision to approve the treatment in early June, even as patient advocacy groups such as the Alzheimer’s Association decried the company’s sky-high list price for the monthly injections totaling at least $56,000 for a year’s supply. In addition, out-of-pocket costs for Alzheimer’s patients undergoing imaging and other ancillary services could reach $11,500, according to a report from the Kaiser Family Foundation.
“The accelerated approval was based on very solid grounds … I do believe that will play out over time, as people see that was a very appropriate use of that authority and the right thing to do for patients,” Woodcock said on July 14. “Was the process done exactly the best that it could be? Possibly not.”
As calls mounted for an independent investigation into the under-the-table meeting between FDA officials and Biogen representatives, first reported in the medical news source Stat, Woodcock acquiesced and requested the Office of Inspector General for the Department of Health and Human Services to get involved. The inspector general has not confirmed yet that it will take up her request, but OIG spokeswoman Tesia Williams told the Washington Examiner, “We received the letter and are reviewing it for appropriate action. We do not have any further comments at this time.”
