In January, a group of nonprofit advocacy groups wrote to Mr. Becerra, the health secretary nominee, and Norris Cochran, the acting health secretary, saying that Dr. Woodcock’s 25-year tenure as F.D.A.’s drug division chief should disqualify her from consideration for commissioner.
“Much of the responsibility for the opioid crisis clearly rests with industry,” the group wrote. “But the fact that opioid manufacturers for decades disseminated false claims about the risks and benefits of opioids points to a dereliction of duty” by Dr. Woodcock’s division.
The letter cited a 2017 presidential commission report on the opioid crisis, which found that it was caused in part by “inadequate oversight by the F.D.A.”
Dr. Woodcock’s role in the approval of new opioid products has also drawn strong opposition from some members of Congress, including Democratic Senators Maggie Hassan of New Hampshire and Edward J. Markey of Massachusetts. Senator Joe Manchin of West Virginia, has also been very critical of the F.D.A.’s handling of opioids under Dr. Woodcock.
“Multiple past F.D.A. commissioners have acknowledged that the F.D.A. made mistakes regarding the opioid crisis, yet the agency still has not fully reckoned with its past missteps,” Senator Hassan said in an email. “The F.D.A.’s decision-making processes for the approval and labeling of opioid drugs going back decades remain of serious concern, and it’s important that the next F.D.A. commissioner is someone who has demonstrated that they have learned from the F.D.A.’s past mistakes — not someone who has been involved in repeating them.”
The nonprofit advocacy groups’ letter prompted a defense of Dr. Woodcock orchestrated in large part by Ellen Sigal, co-founder of Friends of Cancer Research. Ms. Sigal is also chairwoman of the Reagan-Udall Foundation for the F.D.A., an influential organization created by Congress to help advance the agency’s mission and to speed development of new medical treatments.
Friends of Cancer Research receives much of its funding from drug companies. The 2019 top donor list for Friends of Cancer Research includes Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly Co., Genentech, Gilead, Merck, Pfizer and PhRMA, the pharmaceutical industry trade group. The Reagan-Udall Foundation receives funding directly from the F.D.A., but also lists drug industry donors, among them: Biogen, Johnson & Johnson, Teva and the Biotechnology Innovation Organization, known as BIO, which gave Dr. Woodcock an award in 2019 in conjunction with the Science History Institute.