Biden urged not to give top FDA job to official over her role in opioid crisis

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Groups fighting the US opioid epidemic have called on Joe Biden to appoint a new head of the Food and Drug Administration after describing the acting commissioner as unfit for the post because of her part in the mass prescribing of painkillers that have caused hundreds of thousands of deaths.

In a letter to the administration, 28 groups accused Dr Janet Woodcock of presiding over “one of the worst regulatory agency failures in US history” as head of the FDA department responsible for approving new prescription opioids, the Center for Drug Evaluation and Research (CDER).

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Woodcock was named acting FDA commissioner by the new administration on the day Biden took office. The letter urged the president not to nominate her to permanently head the agency.

“In its opioid decision-making, Dr Woodcock, and the division she supervised, consistently put the interests of opioid manufacturers ahead of public health, often overruling its own scientific advisors and ignoring the pleas of public health groups, state Attorneys General, and outraged victims of the opioid crisis,” the letter said.

The Guardian has contacted the FDA for comment.

The signatories of the letter include the medical group Physicians for Responsible Opioid Prescribing, the consumer advocacy organisation Public Citizen, and campaign groups representing families harmed by opioids such as Fed Up!.

The letter accused Woodcock of “dereliction of duty” for allowing opioid manufacturers to spend years disseminating false claims that narcotic painkillers were less addictive and more effective than they really were, contributing to the rise of mass opioid prescribing and spread of an epidemic that has claimed more than 500,000 lives.

“Recent reports that the pharmaceutical industry enthusiastically supports Dr Woodcock’s candidacy for FDA Commissioner do not surprise us,” the letter said.
“We strongly urge that her position as Acting Commissioner be a very short transition prior to President Joe Biden nominating a Commissioner who has a track record focused on public health.”

Two US senators who have previously criticised the FDA’s handling of opioids, Ed Markey and Maggie Hassan, backed the call for a different person to head the agency.

“The FDA’s decision-making processes for the approval and labelling of opioid drugs going back decades remain of serious concern, and it’s important that the next FDA Commissioner is someone who has demonstrated that they have learned from the FDA’s past mistakes – not someone who has been involved in repeating them,” they said in a joint statement.

It is not clear whether Biden intends to nominate Woodcock to head the FDA permanently.

The criticism comes at a sensitive time for the FDA after its credibility was shaken by political interference by Donald Trump over coronavirus. But the agency was already facing accusations that it was less interested in regulating opioid manufacturers than protecting their financial interests.

The FDA helped unleash the epidemic two decades ago when it approved the sale of a high-strength narcotic pill, OxyContin, as safer and more effective than other painkillers based on the false claims of the manufacturer, Purdue Pharma. Since then the agency has approved other opioids for wide prescribing even as the evidence mounted that the drugs were addictive, open to abuse and often not effective for long-term use.

The FDA was also embarrassed by revelations that officials responsible for opioid approvals were taking part in “pay to play” schemes where manufacturers paid tens of thousands of dollars to attend meetings to draw up the criteria for approving prescription narcotics.

In 2017, President Trump’s opioid commission identified the failure of the FDA and other federal institutions to properly regulate opioids as an important factor in the rise of the epidemic.

The letter noted that Woodcock was instrumental in the approval of a powerful opioid, Zohydro, even though the FDA’s own scientific advisory committee voted 11-2 to keep the drug off the market because it was unsafe. The FDA leadership has the authority to override the decisions of its advisory committees.

Dr Raeford Brown, a former chair of the FDA’s opioid advisory committee, described Woodcock as a very able administrator who played an important role in maintaining continuity at the agency when commissioners changed with each new administration. But he said the part she played in unleashing prescription opioids into America without sufficient controls or oversight made her “unfit” to head the FDA.

“The way the whole issue of opioids played out, and the development of policy in CDER, was clearly a cause of the opioid crisis because there was a wilful blindness.

“They didn’t want to see that the things they were doing were causing the problem. She was in charge of that. She more than anybody should be held accountable. I’m shocked she hasn’t been held accountable,” said Brown.

“She chose to support the pharmaceutical industry and neglect the public health issues.”