https://www.usatoday.com/story/opinion/2021/02/03/janet-woodcocks-failure-fda-opioid-epidemic-column/4352787001/
FDA's Janet Woodcock failed to stop the opioid epidemic
Drug manufacturers such as Purdue might have ignited the deadly opioid crisis. However, the FDA was instrumental in allowing the epidemic to play out.
When the Biden administration tapped Janet Woodcock as the acting commissioner of the Food and Drug Administration, it seemed a good pick. Woodcock had spent 23 years as chief of the Center for Drug Evaluation and Research, a unit the FDA describes as its “consumer watchdog" in America’s health care system. The CEDR is tasked with making certain that drugs are “safe and effective,” and “that the health benefits outweigh known risks.”
The administration made it clear that Woodcock’s interim role was an audition for the full-time position. “Six people familiar with the deliberations” told Politico that Woodcock is one of three on a shortlist, the others being ex-FDA Deputy Commissioner Joshua Sharfstein and current Deputy Commissioner Amy Abernethy.
Woodcock’s appointment, however, is a potential land mine for the new administration. The possibility she could be nominated as the permanent commissioner has sparked a firestorm among anti-opioid advocacy groups and victims of the opioid crisis. They charge that she was a central figure responsible for the FDA’s failure over a quarter-century to adequately control the opioid epidemic.
Dr. Andrew Kolodny, a senior scientist and medical director of Brandeis' Opioid Policy Research Collaborative, told me, “It’s no exaggeration to say that she presided over the worst medical regulatory failure in U.S. history.”
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Allowing opioid epidemic to happen
During five years of reporting into a history of the American pharmaceutical industry, I discovered there was plenty of blame to go around in the opioid epidemic.Those culpable were not just pharmaceutical companies that aggressively promoted their addictive products, but also overprescribing doctors, multibillion dollar drug distributors who hid the high volume of orders to so-called pill mills and even national pharmacy chains, where secret bonuses prompted druggists to direct patients to higher profit narcotic painkillers.
I also came across evidence that the FDA was partly responsible for the epidemic. Unlike the others who were motivated by greed, the fault of the FDA was that it repeatedly failed to fulfil its role as the nation’s guardian of public health. Instead, the opioid crisis is filled with instances of the FDA’s timid enforcement, too easy approval of narcotic painkillers and regulatory decisions friendly to drug manufacturers. Some of its worst lapses were with Purdue Pharma and its blockbuster narcotic painkiller, OxyContin.
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FDA's miserable failure
As the Opana debacle played out over several years, Woodcock oversaw the approval of a series of controversial opioid painkillers. An FDA advisory committee had voted 11-2 against approving Zohydro, a narcotic painkiller five to 10 times more powerful than Vicodin, Woodcock and the FDA instead pushed it through.
That prompted 29 state attorneys general and 40 medical and addiction experts to urge the FDA to reverse itself. Sen. Joe Manchin, D-Va., introduced a bill to compel the FDA to rescind its Zohydro approval.
Instead of backing down, Woodcock and her colleagues in the FDA leadership oversaw the agency’s approval in 2014 of Hysingla ER, a controversial successor to Opana. A year later, Woodcock and Sharon Hertz, the director of the FDA’s Division of Anesthesia, Analgesia, and Addiction, further broadened OxyContin’s indication to include children as young as 11.
A presidential Commission on Combating Drug Addiction and the Opioid Crisis concluded in 2017 that the FDA’s “inadequate oversight” had in part caused the nation’s opioid epidemic. This did not slow the FDA’s narcotic painkiller pipeline.
In 2018, it gave the controversial OK to Dsuvia, a sufentanil pill 10 times more powerful than fentanyl. This was despite the strong objection of Dr. Raeford Brown, an anesthesiologist who chaired the opioid advisory committee.
Brown later told the Guardian there was “a war” inside the FDA between those officials who had “failed to learn the lessons” about the deadly epidemic and those who had. In an unusually blunt assessment, Brown said the “FDA has learned nothing. … The lack of insight that continues to be exhibited by the agency is in many ways a willful blindness that borders on the criminal.”
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