Susan F. Wooden, a girls’s well being skilled who resigned in protest from the Meals and Drug Administration in 2005, accusing the company of knuckling underneath to politics by not approving over-the-counter gross sales of the morning-after capsule often called Plan B, died on Jan. 17 at her house in London. She was 66.
The trigger was the mind most cancers glioblastoma multiforme, mentioned Richard Payne, her husband.
Dr. Wooden was assistant commissioner for ladies’s well being on the F.D.A. in the course of the presidency of George W. Bush when Plan B, a type of emergency contraception, grew to become a flashpoint within the abortion wars.
An F.D.A. advisory panel voted 28-0 in 2003 that the capsule was secure for nonprescription use. However senior company officers disregarded precedent and refused to approve over-the-counter gross sales.
Plan B incorporates excessive ranges of progestin, a hormone present in bizarre contraception drugs, and company scientists thought-about it to be a contraceptive. However abortion opponents argued that its use was tantamount to ending pregnancies. They additional warned that prepared entry would result in promiscuous habits by youngsters, although no information supported that declare.
Dr. Wooden and others believed that having emergency contraception out there with out a prescription would imply fewer undesirable pregnancies and fewer abortions.
In August 2005, the F.D.A. commissioner, Lester M. Crawford, introduced that the company couldn’t attain a choice on whether or not to authorize over-the-counter use of Plan B and didn’t count on to achieve one quickly.
Dr. Wooden blamed politics for the company’s foot-dragging and resigned from a job she had held for 5 years. In an e-mail to the employees, she wrote that she may now not stay “when scientific and scientific proof, absolutely evaluated and really useful for approval by the skilled employees right here, has been overruled.”
A report later that yr by the Authorities Accountability Workplace, the nonpartisan investigative arm of Congress, discovered that high company officers had rejected over-the-counter gross sales even earlier than the scientific assessment of Plan B was full. Officers disputed the findings.
Dr. Wooden addressed the American Affiliation for the Development of Science in 2006 and obtained a standing ovation. She criticized the F.D.A. for ignoring science as a result of “social conservatives have excessive undue affect.”
Susan Franklin Wooden was born on Nov. 5, 1958, in Jacksonville, Fla., one in every of 4 kids of Dr. Jonathan Wooden, a surgeon, and Betty (Dorscheid) Wooden.
She graduated from the Episcopal Faculty of Jacksonville in 1976 and Southwestern at Memphis (now Rhodes School) in 1980. After incomes a Ph.D. in biology from Boston College in 1989, she shifted her focus to well being coverage.
In 1990, she obtained a fellowship as a science adviser to the Congressional Caucus for Ladies’s Points, a bipartisan group. Over 5 years on Capitol Hill, she helped push laws to extend the illustration of ladies in scientific trials and to broaden analysis into breast most cancers, infertility and contraception.
In 1995 she grew to become coverage director within the Workplace on Ladies’s Well being, a part of the Division of Well being and Human Companies. She joined the F.D.A. in 2000 to guide the ladies’s well being division.
Objections to approving Plan B for over-the-counter gross sales zeroed in on whether or not it needs to be out there to youthful youngsters. The producer, Barr Laboratories, proposed limiting gross sales to folks 16 and up.
A senior F.D.A. official instructed Dr. Wooden that the drug was on monitor to win nonprescription approval for these 17 and older, Dr. Wooden recalled in an oral historical past that she recorded for the company in 2019.
“I heard that with my very own little ears,” she mentioned. “And everybody was ready for the choice to return out, silently.”
“However,” she added, “the choice by no means got here out.”
On a Friday afternoon, Dr. Crawford introduced that an age restriction for over-the-counter gross sales could be exhausting for pharmacies to handle. The difficulty, he mentioned, wanted extra research. Within the meantime, nonprescription use was not accepted for anybody.
Dr. Wooden stop the subsequent Tuesday. She anticipated her choice to go principally unnoticed. As a substitute, the information media immediately reported on it.
“I ended up spending the subsequent eight months actually simply touring and talking about this,” she mentioned. “It affected the notion of whether or not or not you could possibly belief authorities on the time.”
In 2006, Dr. Wooden joined the Milken Institute Faculty of Public Well being at George Washington College as a analysis professor. She grew to become a full professor in 2017 and directed the Jacobs Institute of Ladies’s Well being there. She and her husband moved to the Isle of Mull in Scotland in 2017, with a second residence in London; she continued to show remotely till she retired in 2022.
Moreover her husband, she is survived by a daughter, Bettie Wooden Payne.
The contretemps over Plan B pale, overshadowed by extra contentious episodes of abortion politics. Plan B lastly gained over-the-counter approval in 2013, although some states enable pharmacists to refuse to dispense it.
In 2019, Dr. Wooden mentioned fears that easy accessibility to a morning-after capsule could be a “harmful, radical, loopy” factor proved to be overblown.
“As soon as it’s over-the-counter, it’s no massive deal,” she mentioned. “And, positive sufficient, that’s what occurred. It’s no massive deal.”