Issue: Politicization of Science 

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Over the past few years, there have been several instances in which the integrity of research has been threatened by actions taken by the federal government based on political and ideological considerations rather than on sound science. Three prominent examples are the Food and Drug Administration’s (FDA) August 2005 delay on the decision to allow the Plan B emergency contraceptive to be sold over the counter; the attempt to nominate Dr. David Hager to chair the Food and Drug Administration (FDA) Reproductive Health Drugs Advisory committee in fall 2002 and congressional efforts to restrict funding forgrants at the National Institutes of Health (NIH) in July 2003.

Plan B OTC delay

On August 26, 2005, then-FDA commissioner Lester Crawford, Ph.D., announced that the agency would not immediately make a final decision on allowing the Plan B emergency contraceptive to be sold over the counter, citing concerns about how the drug could be available without prescription to women over 17 while remaining prescription only for younger women. This delay occurred in spite of a 23 to 4 vote of the FDA Reproductive Health Drugs Advisory committee in favor of granting over-the-counter status to this drug. Instead, Dr. Crawford said that FDA would open up a 60-day comment period on the drug’s OTC approval. Previously, HHS Secretary Michael Leavitt had promised that action would be taken on Plan B by September 1 in exchange for the removal of a hold placed by Senators Patty Murray (D-WA) and Hillary Rodham Clinton (D-NY) on Crawford’s nomination to head the FDA. Dr. Crawford has since resigned as head of the agency.

Following the announcement of the Plan B delay, Susan Wood, Ph.D., resigned on August 31 as FDA Office of Women’s Health (OWH) director to protest the agency’s lack of action. In her resignation letter, Dr. Wood wrote, “The recent decision announced by the Commissioner about emergency contraception, which continues to limit women's access to a product that would reduce unintended pregnancies and reduce abortions is contrary to my core commitment to improving and advancing women's health. I have spent the last 15 years working to ensure that science informs good health policy decisions. I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled.”

Nomination of Dr. Hager to chair FDA Reproductive Health Drugs Advisory Committee

The potential appointment of Dr. David Hager in fall of 2002 to chair FDA’s Reproductive Health Drugs Advisory committee drew a barrage of protests from women’s health groups, including the Society for Women’s Health Research. These groups were concerned about his strong ideological views and negative activism, such as his reported reluctance to prescribe contraceptives to unmarried women and his emphasis on prayer for the relief of premenstrual syndrome and other afflictions. SWHR was troubled by the possibility of Dr. Hager’s appointment to a position in which he would be able to have a significant impact on decisions affecting the health of American women. In the wake of considerable controversy and an effort led by SWHR and other organizations, HHS announced that Dr. Hager would sit on the committee, but would not serve as its chair.

After being re-appointed to the committee, in May 2005 it was reported that Dr. Hager had written a memo advising the FDA against approval of the Plan B emergency contraceptive for over-the-counter sale, despite the Reproductive Health Drugs Advisory committee’s 23 to 4 vote in favor of granting over-the-counter status to this drug. Senators Hillary Rodham Clinton (D-NY) and Patty Murray (D-WA) subsequently wrote to HHS Secretary Michael Leavitt urging him to investigate Dr. Hager’s actions and whether he allowed his personal beliefs rather than scientific evidence to influence the FDA’s Plan B decision.

Congressional Efforts to Target NIH Grants

In July 2003 , Representatives Patrick Toomey (R-PA) and Chris Chocola (R-IN) introduced an amendment to the House Labor/HHS appropriations bill to restrict federal funding to the National Institutes of Health (NIH) for five grants dealing with sexual health research. However, a number of bipartisan members of Congress opposed the amendment on the grounds that NIH should be free to decide which grant proposals it will fund through its peer-review process based on scientific merit, without interference from the federal government. The amendment was narrowly defeated in the House by a vote of 212-210. Similar legislation sponsored by Representative Randy Neugebauer (R-TX) passed the House in 2004, but was not ultimately included in the final Labor/HHS appropriations bill. In 2005, another amendment to eliminate funding for specific NIH grants was attached to the House Labor/HHS appropriations bill and approved during the House floor vote, though no action has yet been taken by the Senate.

The Society for Women’s Health Research believes that these threeexamples illustrate clearly the dangers of the federal government interjecting political or ideological views into scientific affairs and women’s health issues. The trend toward politicization of science is harmful to researchers, who may fear to undertake important but potentially controversial research if they think such efforts will result in unwanted attention or interference from the federal government. Further, the general public will suffer if research is stymied due to ideological concerns or politics, and it is likely that women will be harmed if advisory committee appointments in the area of women’s health are made based on ideology rather than science.

Read SWHR's action alert on Scientific Integrity
Read SWHR’s action alert on politicization of science.
Read SWHR's statement on FDA's Plan B Decision.
Read SWHR's action alert on the re-appointment of Dr. David Hager.