Susan F. Wooden, a girls’s well being knowledgeable who resigned in protest from the Meals and Drug Administration in 2005, accusing the company of knuckling below to politics by not approving over-the-counter gross sales of the morning-after capsule often known as Plan B, died on Jan. 17 at her residence in London. She was 66.
The trigger was glioblastoma multiforme, a mind most cancers, stated Richard Payne, her husband.
Dr. Wooden was assistant commissioner for girls’s well being on the F.D.A. through the presidency of George W. Bush when Plan B, a type of emergency contraception, turned 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 atypical contraception capsules, and company scientists thought of 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 conduct by youngsters, although no information supported that declare.
Dr. Wooden and others believed that having emergency contraception obtainable 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 anticipate to succeed in 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 not stay “when scientific and scientific proof, absolutely evaluated and beneficial for approval by the skilled employees right here, has been overruled.”
A report later that 12 months 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 evaluate of Plan B was full. Officers disputed the findings.
Dr. Wooden addressed the American Affiliation for the Development of Science in 2006, the place she acquired 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 youngsters of Dr. Jonathan Wooden, a surgeon, and Betty (Dorscheid) Wooden, who managed the house.
She graduated from the Episcopal College 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 acquired 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 increase analysis into breast most cancers, infertility and contraception.
In 1995 she turned 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 must be obtainable to youthful youngsters. The drug’s maker, Barr Laboratories, proposed limiting gross sales to folks 16 and up.
A senior F.D.A. official informed 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 stated. “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 can be laborious for pharmacies to handle. The problem, he stated, wanted extra research. Within the meantime, nonprescription use was not permitted for anybody.
Dr. Wooden stop the subsequent Tuesday. She anticipated her choice to go principally unnoticed. As an alternative, the information media immediately reported on it.
“I ended up spending the subsequent eight months actually simply touring and talking about this,” she stated. “It affected the notion of whether or not or not you can belief authorities on the time.”
In 2006, Dr. Wooden joined the Milken Institute College of Public Well being at George Washington College as a analysis professor. She turned a full professor in 2017 and served as director of 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.
Apart from her husband, she is survived by a daughter, Bettie Wooden Payne.
The contretemps over Plan B finally light, overshadowed by extra contentious episodes of abortion politics. Plan B lastly received over-the-counter approval in 2013, although some states permit pharmacists to refuse to dispense it.
In 2019, Dr. Wooden stated fears that easy accessibility to a morning-after capsule can be a “harmful, radical, loopy” factor proved to be overblown.”
“As soon as it’s over-the-counter, it’s no massive deal,” she stated. “And, positive sufficient, that’s what occurred: It’s no massive deal.”