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 worse medical regulatory failure in U.S. history.”
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.
Purdue managed several significant victories. Despite safety studies demonstrating Oxy was safe for “short term” use, mostly severe end-of-life pain, the FDA approved Oxy for much broader treatment of chronic pain, everything from fibromyalgia to back pain. And while Purdue had not conducted any clinical trials to determine whether OxyContin was less likely to be addictive or abused than other opioid painkillers, the FDA allowed Purdue to claim on Oxy’s insert that its delayed absorption was “believed to reduce the abuse liability.” The drug’s label declared that addiction “is rare.” That freed Purdue’s marketing team to push their drug as much safer than any opioid competitor.
Woodcock was still chief of the FDA’s watchdog group in 2001 when advocates argued for changes to OxyContin label to address the rapidly increasing rates of addiction and overdose. The FDA and Woodcock rebuffed most of the proposed reforms and instead approved mostly inconsequential changes to Oxy’s label. Victim’s groups had asked the FDA to rescind its endorsement of dispensing Oxy for chronic pain. Instead, the revised label said OxyContin was “for the management of moderate to severe pain when a continuous, around the clock analgesic is needed for an extended period of time.”
Former FDA Commissioner David Kessler contends that the “label change was a blank check.” The broad language resulted in billions in additional sales for Purdue.
As evidence poured in that opioid prescribing had exploded and that overdoses followed, the FDA hurriedly convened an advisory panel of 10 experts the following year and tasked them with recommending whether the agency should forbid dispensing opioids for chronic pain. There was no notice from Woodcock or the agency that Purdue had paid five of those panelists as consultants or through its speakers program. Three others had done similar work for other opioid manufacturers. Not surprisingly, the panel recommended no change in the FDA’s permissive labeling.
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Woodcock and the FDA then took six more years before they removed from Oxy’s label the claim that the risk of addiction was rare. The missteps regarding opioids continued unabated. In 2010, with Woodcock still at the helm of CEDR, Purdue won approval for a “new and improved” tamper-resistant OxyContin, although the agency’s own field tests demonstrated the new formulation had “no effect” in reducing abuse potential.
The following year, the FDA approved Endo Pharmaceutical’s Opana ER, an extended released opioid painkiller the manufacturer also touted as “tamper-resistant.” When ultimately the FDA was forced to request Endo pull Opana from the market, Woodcock admitted, “We determined that the product had dangerous unintended consequences.”
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.”
Brown joined Sidney Wolfe, founder of Public Citizen’s Health Research Group, calling for Woodcock to resign for her failure to implement National Academy of Sciences recommendations to improve the FDA’s approval and regulation of opioids.
Sens. Margaret Hassan, D-N.H., and Edward Markey, D-Mass., wrote to the FDA in 2019 asking for a “fuller accounting of its past decision-making processes for the approval and labeling of opioid drugs.”
Woodcock wrote a defensive and lengthy response claiming that the agency had always followed the letter of the law, and that the “FDA is fully committed to looking closely at the opioid crisis, learning from what happened, and identifying missed opportunities.”
Manufacturers such as Purdue might have ignited the deadly opioid crisis. However, to the families of victims, the FDA was instrumental in allowing the epidemic to play out.
Many of them are enraged by Woodcock’s appointment as the interim FDA chief. They would be devastaed, however, if Woodcock were to be nominated as the permanent commissioner. The Biden administration should avoid rewarding any government official who contributed to the opioid crisis having become the most lethal prescription drug epidemic in American history.
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