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Janet Woodcock

Acting FDA Commissioner

Janet Woodcock is a career civil servant of the Food and Drug Administration (FDA) who has served in various leadership roles at the FDA under both Democratic and Republican administrations since 1986. Woodcock has served as Acting FDA Commissioner since January 2021 and is also reportedly under consideration to fill the FDA Commissioner role permanently. In 2003, Woodcock expressed harmful and false claims about access to Plan B during the review process of making Plan B more readily available. In recent years, Woodcock expressed support for evidence-based decisions regarding the approval of Plan B as an over-the-counter product and the approval of a protocol to expand the use of medication abortion. In recent months, Woodcock received criticism for her lack of oversight of the opioid crisis while serving as chief of the FDA’s Drug Division. In April 2021, under Woodcock’s direction, the FDA lifted Trump administration bans on dispensing abortion pills via telehealth during the COVID-19 pandemic. Equity Forward has labeled Woodcock as green with caution due to previous harmful claims she made around reproductive health care access but acknowledges Woodcock has since made progress.

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Woodcock Was Reported As Acting Commissioner For The Food And Drug Administration On January 14, 2021

Bloomberg News First Reported Woodcock As The Acting FDA Commissioner On January 14, 2021. “Woodcock is expected to serve as acting head of the drug regulator after Biden’s inauguration next week…” [Bloomberg News, 1/14/21] 

Center Watch Reported Woodcock Will Serve As The Acting FDA Commissioner Beginning On January 20, 2021. “FDA veteran Janet Woodcock has reportedly been short-listed by the incoming Biden administration to serve as the agency’s next commissioner and will also likely serve as acting chief until the position is filled. Woodcock is expected to assume the role of acting FDA commissioner on Jan. 20 after President-elect Biden is inaugurated and current chief Stephen Hahn steps down from the agency.” [Center Watch, 1/18/21] 

Bloomberg News Also Reported Woodcock Is A Top Candidate For The More Permanent Role Of FDA Commissioner. “Janet Woodcock, a 30-year veteran of the Food and Drug Administration, is being considered by President-elect Joe Biden to serve as commissioner of the agency, according to people familiar with the selection process…while being vetted by the Biden team for the permanent job along with former FDA principal deputy commissioner Joshua Sharfstein, according to the people.” [Bloomberg News, 1/14/21] 

Bloomberg News Stated The Timing Of Woodcock’s Roles Remains Unclear. “If Biden were to choose Woodcock, it’s unclear whether she would remain acting commissioner during the confirmation process. There have been past instances where an acting head stayed in the post while lawmakers weighed their nomination.” [Bloomberg News, 1/14/21] 

Previous Employment Of Note

Woodcock Expressed A Commitment To Using Evidence-Based Science

Woodcock Contributed To An Op-Ed With Other FDA Executives Assuring Their Commitment To Using Evidence-Based Science Amid Political Turmoil. “We are the senior career civil servants who direct the work of the various centers at the FDA. Together we are responsible for over 17,000 employees, and among us we have over 100 years of experience at FDA. We care deeply about our agency, its mission and its people…We absolutely understand that the FDA, like other federal executive agencies, operates in a political environment…we and our career staff do the best by public health when we are the decision-makers, arriving at those decisions based on our unbiased evaluation of the scientific evidence…” [USA Today, 9/10/20] 

Woodcock Is Viewed As A Dependable Career Scientist. “Not only was [Stephen] Hahn’s time as [FDA] commissioner defined by the pandemic, it was also defined by constant public struggles with the demands of the Trump White House to approve untested treatment options, particularly as the 2020 election neared. In August, Hahn was forced to walk back efficacy statements made about convalescent plasma for COVID-19 during a White House briefing…as a career regulator, Woodcock will be seen as a steady hand for the agency until the Biden administration can name a new commissioner.” [BioSpace, 1/14/21] 

Woodcock Was Involved In Controversy Surrounding The FDA’s Initial Review Of Changing Plan B To Over-The-Counter Status In 2003

Woodcock Was Involved In Controversy Over Her Role In Reviewing The Application To Make Plan B Available Over The Counter In 2003. “In April 2003, Women's Capital applied to make Plan B available over the counter. Barr [Laboratories] bought the rights to the drug and continued to pursue the application. An advisory committee voted 23 to 4 in December 2003 to recommend approving the switch. Within days of the committee's vote, however, Dr. Janet Woodcock, the F.D.A.'s acting deputy commissioner of operations, and Dr. Steven Galson, acting director of its drug center, told four top staff members that the application would be rejected, even though the agency's scientific review of the application had yet to be completed, the staff members told Congressional investigators. That review was completed in April. Drs. Woodcock and Galson denied to investigators that they had made such statements.” [The New York Times, 11/15/05] 

Despite An FDA Advisory Committee’s Vote To Make Plan B Available Over The Counter In 2003, The FDA Ultimately Denied The Application In 2004. “…In 2003, the product's manufacturer applied for OTC status. Two FDA expert advisory panels, convened together in December of that year, voted overwhelmingly in favor of the switch. The 28-member joint body unanimously deemed the drug safe for OTC sales. Nonetheless, the FDA failed to approve the application in May 2004, citing concerns that OTC availability of Plan B might increase sexual activity, and therefore the risk of sexually transmitted infections, among young teens.” [The Guttmacher Institute, 11/1/05]

 

Then-FDA Deputy Commissioner Woodcock Expressed Inaccurate, Harmful Claims During The Review Process Of The Application For Plan B’s Over-The-Counter Status 

Woodcock Made The False, Fearmongering Claim That Making Plan B More Readily Accessible Could Lead To “Extreme Promiscuous Behaviors” Among Teens, Including “Sex-Based Cults.” “Meanwhile a government report later found that Dr. Janet Woodcock, deputy commissioner for operations at the F.D.A., had also expressed a fear that making the drug available over the counter could lead to ‘extreme promiscuous behaviors such as the medication taking on an 'urban legend' status that would lead adolescents to form sex-based cults centered around the use of Plan B.’” [The New York Times, 5/7/06]

 

In Recent Years, Woodcock Supported Evidence-Based Decisions During The FDA’s Approval Processes Of Over-The-Counter Sales Of Plan B In 2013 And Medication Abortion Protocols In 2016

Woodcock Was At The Helm Of FDA Leadership During The Over-The-Counter Approval Of Plan B In 2013. “The Food and Drug Administration Thursday evening approved over-the-counter sale, with no age restrictions, of Plan B One-Step. That's the morning-after pill whose status has been the subject of a dozen years of political wrangling and legal dispute. The action came after a court order issued in April by a federal district court judge in New York. The Obama administration originally appealed the ruling, but when it became clear that it would lose, agreed to make the product available as ordered. ‘Over-the-counter access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,’ said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a statement.” [NPR, 6/21/13] 

Planned Parenthood Action Fund Commended The FDA For Updated, Evidence-Based Protocols For Medication Abortion While Woodcock Served Among FDA Leadership. “Yesterday, the U.S. Federal Drug Administration (FDA) approved new protocols for medication abortion that are rooted in science — not politics — and that encourage all 50 states to provide it through an evidence-based standard. Although this label change does nothing to get intrusive laws out of women’s exam rooms, it does represent a significant step forward for reproductive health...Simply put, the ‘new’ protocol aims to improve the use of medication abortion. The FDA’s announcement is a significant step forward for science and women’s health — it means that health care providers can provide medication abortion according to the highest standard of care established after more than 15 years of research and experience.” [Planned Parenthood Action Fund, 3/31/16] 

Woodcock Received Criticism For The Mishandling Of The Opioid Crisis While Serving As Chief Of The FDA’s Drug Division

Woodcock Has Drawn Criticism Over The Lack Of Oversight From The FDA’s Drug Division, Which She Led Amid The Opioid Crisis. “Dr. Woodcock’s decades of service at the F.D.A. have made her more of a target for critics, and she has drawn particular fire over her agency roles during the opioid crisis… But the loudest objections to Dr. Woodcock focus on the F.D.A.’s role in the opioid epidemic during her two stints as chief of its drug division, from 1994 to 2004 and then again from 2007 until she moved to Operation Warp Speed last May. (Between those two postings, she held other roles at the agency.) 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… 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.’” [The New York Times, 3/9/21] 

Under Woodcock’s Direction, The FDA Followed Evidence-Based Science And Removed Trump-Era Restrictions On Dispensing Abortion Pills During The COVID-19 Pandemic

With Woodcock Serving As The Acting FDA Commissioner In April 2021, The FDA Lifted Bans On Dispensing Abortion Pills During The COVID-19 Pandemic. “The Biden administration is lifting restrictions on dispensing abortion pills by mail during the Covid-19 pandemic, reversing a Trump administration policy that the Supreme Court backed in January. Acting FDA Commissioner Janet Woodcock informed the American College of Obstetricians and Gynecologists in a letter Monday that her agency concluded that allowing patients to receive the pills via telemedicine and through the mail will not increase risks and will keep people safe from contracting the virus.” [Politico, 4/12/21]

In A Letter To The American College Of Obstetricians And Gynecologists And The Society For Maternal-Fetal Medicine, Woodcock Said The FDA’s Updated Decision Followed Evidence-Based Science.  

[ACOG Action Twitter, 4/12/21] 

 

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