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OxyContin Decision Involved FDA ‘Miscalculation,’ Woodcock Says

June 15, 2022, 6:31 PM

A top FDA official who oversaw the approval of Purdue Pharma‘s OxyContin said Wednesday that the agency failed to adequately predict the harms associated with the drug that has fallen into the center of the US opioid epidemic.

Janet Woodcock, now the Food and Drug Administration’s principal deputy commissioner, said in remarks at the Food and Drug Law Institute’s annual conference that there was a “miscalculation about projected harms” of the opioid painkiller, which the agency first approved in 1995 when Woodcock served as the director of the Center for Drug Evaluation and Research.

The comments mark one of the latest admissions from the FDA on missteps in its approval of OxyContin—one of lawmakers’ main sticking points against Woodcock’s nomination for the agency’s top job.

“The projection of the harms and the projection of the behaviors was way off,” said Woodcock, who served as the FDA’s acting commissioner for the first year of President Joe Biden‘s administration before Robert M. Califf’s confirmation.

Woodcock said there can sometimes be “uncertainty” in the FDA’s harm and risk analysis of new drugs, and that it can be “difficult to predict” the level to which improper prescribing and misuse can occur. The FDA’s second-in-command gave the conference address after receiving an award from the FDA Alumni Association.

FDA’s Opioid Legacy

Since the FDA’s OxyContin approval, the agency has taken action to try to limit misuse and educate on the dangers of improper prescribing as rates of opioid overdoses and deaths rise nationwide.

More than 932,000 people have died from a drug overdose in the US since 1999, according to data from the Centers for Disease Control and Prevention. The agency reported nearly 91,800 drug overdose deaths in the US in 2020, with the age-adjusted rate of overdose deaths increasing 31% from 2019.

Califf said in his December 2021 confirmation hearing that he would lead a “comprehensive review” of opioid regulations early in his tenure. He said at the time that his review would include assessing the agency’s labeling process and whether warnings accurately describe the safety risks.

“Approving OxyContin with no long-term studies and no assessment of the addictive capabilities is something that could have been done differently,” Califf said at the hearing.

Woodcock’s extensive experience at the FDA has led many within the agency and across the regulated industry to hold her in high regard. But addiction treatment groups and lawmakers from some of the states hit hardest by the opioid epidemic cited the agency’s approval of OxyContin and other highly addictive opioids in their opposition to having her nominated as the agency’s permanent head.

Sen. Joe Manchin (D-W.Va.) wrote a letter to Biden in June 2021 urging him against nominating Woodcock to serve as the commissioner beyond an acting role. He argued the “FDA has played a critical role in this overdose epidemic by overseeing continuous approvals of stronger and more addictive opioids since the initial approval of OxyContin in 1995—and Dr. Woodcock has been there for all of it.”

Manchin and Sen. Margaret Hassan (D-N.H.) also cited the opioid epidemic in their opposition to Califf’s confirmation, arguing that his extensive ties to the drug industry would limit his resolve to strengthen opioid safety rules. The Senate ultimately voted 50-46 to confirm Califf, a much smaller margin of victory than when he was first confirmed to lead the FDA in 2016.

Purdue Legal Battle

Purdue, which has faced thousands of lawsuits connected to the opioid epidemic, filed for bankruptcy in 2019, and members of the Sackler family involved with the company are seeking a settlement to resolve a series of civil claims by state and local governments.

A proposed $6 billion settlement between Purdue and several states would see money go to addiction-abatement efforts. The Sacklers would also agree to give up their equity in the company and eventually exit the opioid business in exchange for protection from future opioid lawsuits.

A bankruptcy judge approved the deal in 2021, but it was later overturned on appeal and is currently being reviewed by a panel of judges.

Connecticut Attorney General William Tong said June 7 that he would ask the state’s top prosecutor to consider criminal charges against Sackler family members. Purdue and its units have previously pleaded guilty twice to criminal charges—first over allegations that the company misled regulators, doctors, and patients in its marketing of OxyContin, and second to felony charges that it attempted to defraud the US and conspired to violate federal anti-kickback laws.

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editors responsible for this story: Alexis Kramer at akramer@bloomberglaw.com; Karl Hardy at khardy@bloomberglaw.com