In August 2005, the U.S. Food and Drug Administration announced it was delaying a ruling on whether Plan B, an emergency contraceptive pill, should be made available over the counter.
The decision may have passed all but unnoticed among the general public were it not for the actions of Susan Wood, then the assistant commissioner for women’s health at the FDA. Days after the decision was announced, Dr. Wood resigned her position -- and then went public with her reasons.
First in media interviews, and then in an eight-month, 41-city speaking tour, Dr. Wood decried what she saw as political interference in policy decisions that should be informed by science. The decision to make Plan B available over the counter was straightforward in terms of the scientific and medical issues, she argued, but the Bush administration was delaying its decision because of ideological reasons, to the detriment of women’s health.
“There was this real frustration among a wide variety of people that something was going desperately wrong with the functioning of government, specifically around the role of science in government, and that it was just being ignored for completely political reasons,” Dr. Wood said. “This was one of those case studies, a poster child of that activity.”
Through her advocacy, Dr. Wood helped crystallize people’s dismay at the lack of respect for science in policy decisions. Today, she is helping to promote science-based policy through her work at the George Washington University. As an associate professor of health policy and executive director of the Jacobs Institute of Women’s Health at the School of Public Health and Health Services, Dr. Wood is continuing her career-long dedication to women’s health issues while helping to train the next generation of health policy professionals.
“I think that teaching about the real world -- such as it is in Washington -- opens students’ eyes as to how to make change, as well as the challenges they will face outside the academic world,” Dr. Wood said.
When it came to working in health policy, Dr. Wood did not follow a traditional path.
Dr. Wood received a doctorate in biology in 1989 from Boston University. She completed a one-year neuroscience post-doctoral fellowship at the Johns Hopkins University School of Medicine and was deciding what to do next when she learned of the American Association for the Advancement of Science Congressional Science Fellowship. She thought the fellowship would be a great experience to learn how the federal government funds scientific research. Little did she know, it would be the start of a long-term career shaping public policy.
During the AAAS fellowship, she worked on Capitol Hill for the Congressional Caucus for Women’s Issues, for which she would later become the deputy director. She helped the caucus conduct research and spur greater public sector investment in women’s health, including getting more women in clinical trials and developing more contraception options.
“This whole issue of women’s health being much broader, being across the lifespan, really took off in this era of the ’90s,” said Dr. Wood.
She helped to pass legislation on National Institutes of Health-funded research on women’s health, strengthen Centers for Disease Control and Prevention screening programs for breast and cervical cancer and establish offices of women’s health across the U.S. Department of Health and Human Services.
“I learned health policy by doing,” she said.
In 1995, Congress abolished caucuses as staffed organizations so Dr. Wood went to work for the Office of Women’s Health at HHS as the director for policy and program development. And five years later, she landed a position as the assistant commissioner for women’s health and the director of the Office of Women’s Health at the FDA.
The Plan B Saga
The FDA initially approved Plan B in 1999, but only for women who obtained a prescription from a doctor. A few years later, the manufacturers of Plan B – an emergency contraceptive medicine that decreases the chance of pregnancy if taken within three days after unprotected sex – asked the FDA to make its product available over the counter. Advocates for the drug argued that the move would reduce barriers for women being able to obtain emergency contraception and help to reduce unintended pregnancy. Plan B, which contains the same hormone found in many types of oral contraceptives but at a higher dose, works by stopping the ovaries from releasing an egg.
“The actual review of Plan B to go over the counter was a fairly straightforward one. Plan B is just one more contraceptive option for women. It doesn’t change people’s behavior. It’s just something else on the shelf,” Dr. Wood said. “People were aware that there were some sensitivities around it, but in terms of the science or the medical issues, it was very clear cut, very straightforward. It should have been no problem, but it kept being delayed and delayed.”
Typically decisions around new drugs (or a change in status for existing drugs) are based off of the FDA’s Center for Drug Evaluation and Research, which reviews the evidence submitted by the drug manufacturer and determines if the drug is safe and effective for the intended audiences. But this wasn’t the case with Plan B, Dr. Wood said.
“The decision was not allowed to be made down at the reviewer level, which was where it would normally be made. It was pulled up and blocked at the highest levels of the agency repeatedly over time,” she said.
On Aug. 26, 2005, the FDA announced it was once again delaying a ruling regarding Plan B going over the counter by calling for a public rulemaking process.
“I knew exactly what was happening here – it was being thrown into this bureaucratic black hole from whence it would never come out again, or at least not for a very long time,” said Dr. Wood. “And there was absolutely no rationale for it whatsoever.”
Committed to being an advocate for scientific-based policymaking and advancing women’s health, Dr. Wood couldn’t stand by her employer’s decision. Within four days, Dr. Wood resigned from the FDA.
“I couldn’t retain my own self-respect or my reputation as a science-based person to defend this in public,” she said.
She sent an email to her FDA colleagues explaining her decision to resign because she believed the agency’s actions around Plan B were to the detriment of women’s health. Within a few hours, the news of her resignation spread widely.
For the next three days, she did nothing but media interviews, explaining the rationale for her decision. Next, she went to Capitol Hill. And then over the following eight months, she traveled to 41 cities to speak at universities, women’s groups and health organizations hoping to spread awareness and spark outrage about the fact the government was ignoring the science for political reasons.
“When I resigned, it sort of clarified that there was something fundamentally wrong there, because people don’t generally resign really good jobs and say why it is that they resigned,” Dr. Wood said. “We need to trust the FDA to make these decisions based on the data that come before them, not on somebody’s ideological concerns.”
A year later in August 2006, the FDA approved nonprescription sales of Plan B for women 18 and older, but teenage girls younger than 17 still had to obtain a prescription before accessing this emergency contraception. In 2009, a federal judge in New York ordered the FDA to make Plan B available to 17-year-olds within 30 days calling the decision by the Bush administration “arbitrary and capricious,” “lacking all credibility” and influenced by “political and ideological considerations.”
A New Start at GW
After concluding her nearly yearlong tour around the country, Dr. Wood accepted a research faculty position at GW’s School of Public Health and Health Services and began working on a project about the role of scientific knowledge in public policy. In 2009, she became the executive director of the Jacobs Institute of Women’s Health, an organization that seeks to improve health care for women through research, dialogue and information dissemination and publishes the peer reviewed bimonthly journal, “Women's Health Issues.”
Dr. Wood teaches Advanced Health Policy Analysis and Women’s Health, both graduate level courses in SPHHS.
“It's exciting to see students’ interests and passion for improving women's health and working with them to apply these passions to policy and research solutions,” she said.
When she’s not in the classroom, Dr. Wood is a frequently quoted expert on women’s health issues involving public policy.
Last December, she took dozens of press calls when HHS Secretary Kathleen Sebelius overruled FDA Commissioner Margaret Hamburg’s decision to make Plan B available to all females of reproductive age without a prescription. This was the first time in history HHS overruled an FDA decision, and reproductive health advocates argued the move conflicted with a presidential memorandum signed in March 2009, which called for scientific decisions across the federal government to be protected from political influence.
“Once again it’s overruling the best public health, the best medical health, the best clinical health and the best science,” said Dr. Wood. “It’s really unfortunate.”
Dr. Wood isn’t exactly sure why HHS blocked the FDA’s decision, but she speculates it had nothing to do with science and everything to do with politics.
“It could have been that they [the Obama administration] were worried about a backlash if they approved it, or that they would benefit somehow by not approving it. And I would argue that neither one of those is the case,” she said.
As the nation looks toward Election Day next week, Dr. Wood is anxious about the outcome at the polls and what it might mean for women’s health – especially their reproductive health.
Throughout the presidential election, women’s health has been a hot topic ranging from contraception to abortion to the Medicaid expansion and the preventative health measures included in the Affordable Care Act. On the campaign trail, Republican presidential nominee Mitt Romney said he would end funding to Planned Parenthood if elected.
“It would be great to not need to continue to focus on both scientific integrity and issues such as access to contraception, but unfortunately we still face these same challenges,” Dr. Wood said.
She hopes her students will stay committed to science-driven public policy when they leave GW. Her experience with Plan B showed her that people in communities across the country wanted a government – and specifically an FDA – they could trust to make non-partisan and scientifically sound decisions when it came to their health.
“At the time of my resignation, the driving force was to maintain my own sense of scientific integrity,” Dr. Wood said. “And I’ve stayed committed to that integrity throughout my career.”