In its decision not to approve the emergency contraceptive drug Plan B for over-the-counter use, the FDA cited scientifically dubious concerns about the drug’s effect on adolescent girls—a position backed by some social conservatives who argue that easier access to emergency contraception would encourage promiscuity in young women.

An official at the Food and Drug Administration (FDA) overruled the advice of the agency's staff and two independent scientific advisory panels when he decided to deny women over-the-counter access to the emergency contraceptive levonorgestrel (sold under the brand name "Plan B"). Numerous FDA officials and medical advisers to FDA involved in and familiar with the approval process call the move an almost unprecedented repudiation of government scientific expertise. By law, the FDA is required to approve drugs that are found to be safe and effective.

Scientists: sign this statement to voice your concern about the Bush administration's misuse of science.

In the case, Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, acknowledged to reporters that he overturned the recommendations of his own staff and two FDA advisory panels in declaring the drug "not approvable" for nonprescription status.¹ A joint meeting of two independent FDA scientific advisory committees voted 23 to 4 in December 2003 to recommend the emergency contraceptive as an over-the-counter drug. The panel also voted unanimously that the drug could be safely sold over the counter.²

Plan B consists of two high-dose contraceptive pills that either interfere with ovulation or fertilization, or prevent implantation of a fertilized egg. Emergency contraception can be taken up to 72 hours after unprotected sexual intercourse to prevent pregnancy, but is more effective the sooner it is taken. Manufactured by New York-based Barr Pharmaceuticals, Inc., Plan B was approved as a prescription drug in 1999; another emergency contraceptive, Preven, was approved in 1998. Since then, millions of women in the United States have used such drugs to prevent pregnancy. Public health officials and researchers around the world widely agree that Plan B is a safe and effective means to prevent an unplanned pregnancy and to reduce the frequency of abortions. The drug is available without a prescription in 33 countries around the world. Its switch to nonprescription status in the United States was also endorsed by some 70 scientific organizations, including the American Medical Association, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics.³

In the "not approvable" letter to Barr Pharmaceuticals, Galson notes that only 29 of the 585 women in the data submitted by the company about Plan B were 14 to 16 years of age and none was under 14 years of age. While Galson does not cite any particular safety concern for this age group, he writes "we have concluded that you have not provided adequate data to support a conclusion that Plan B can be used safely by young adolescent women for emergency contraception without the professional supervision of a practitioner licensed by law to administer the drug."⁴

James Trussell, director of the Office of Population Research at Princeton University and a member of one of the FDA advisory committees that recommended the drug's approval for over-the-counter sale, says that after hearing many hours of testimony and reviewing thousands of pages of medical literature, "[O]ur committee had absolutely no concern about the use of this drug by young girls." Advisory committee member Dr. Julie Johnson, a professor of pharmacy in Gainesville, Florida, touted Plan B to be the safest product the committee had reviewed in several years.⁵

Advisory committee members also underscored the importance of making recommendations based on a risk-benefit analysis, particularly with regard to young people. Pediatrician Dr. Leslie Clapp from Buffalo, New York, spoke about her own clinical practice and acknowledged that, while abstinence is the best option for teens, "[I]f you are a sexually active teen…or eleven year old, it's certainly a bad situation…I think their families and they would have far preferred this option than pregnancy, and it would have been safer."⁶ Dr. Abby Berenson, a gynecologist from Galveston, Texas, who treats adolescents, echoed the sentiment, adding that "Barriers to use," such as a prescription requirement for Plan B, "will ultimately…result in unintended pregnancies,"⁷ which pose disproportionate health risks to adolescent women, including premature labor, anemia, and high blood pressure.⁸

Medical professionals, including several other prominent members of the advisory committees, take issue with Galson's claim of lack of data on young women. The American Academy of Pediatrics and the Society of Adolescent Medicine noted in a May 27, 2004, statement that approximately one-fifth of the participants in the Barr trials were between the ages of 14 and 16, which represents ages below or consistent with the average age of first intercourse.⁹ In a recent editorial letter to The New England Journal of Medicine, three physicians noted that the advisory panels considered data that showed adolescents understood 60 percent to 97 percent of the key communication objectives of the Plan B label without help from a health care professional. These results are comparable to those for the group as a whole and well within the standards for the approval of other over-the-counter drugs.¹⁰ As Dr. Trussell puts it, "The objection the FDA is offering in denying the switch to a nonprescription status is nothing more than a made-up reason intended to sound plausible. From a scientific standpoint, it is complete and utter nonsense."¹¹

Dr. Trussell says that he has no doubt that politics trumped science in the FDA’s bureaucratic process in this case.¹² In an internal FDA memo obtained by the Associated Press, Galson apparently tried to quell similar questions from his own staff about the role political considerations may have played in the decision, noting that "Some staff have expressed the concern that this decision is based on non-medical implications of teen sexual behavior, or judgments about the propriety of this activity."¹³ Galson responded by claiming that politics did not influence his decision. In a press conference following his decision, Galson denied meeting personally with White House officials in the decision-making process and claimed to have "no knowledge" that any meetings between FDA and White House officials on the Plan B decision took place.¹⁴

Nonetheless, Dr. Galson broke with agency protocol by overruling FDA staff scientists who had concluded that this drug met FDA criteria for nonprescription status and overwhelmingly recommended the switch. In overruling his staff and the advisory committee, Galson offered no substantial new evidence, and took the unusual step of writing the official response to the drug company himself.¹⁵

FDA insiders also note that after the hearings on the matter late last year, conservative groups had mounted a political campaign to try to block the drug's approval. Conservative lawmakers began efforts to undermine the application in December 2003 when members of the House of Representatives sent a letter to the FDA Commissioner decrying purported risks of nonprescription Plan B to teens. The advisory committees addressed these claims and implicitly rejected them in their evaluation of the drug's risk-benefit profile. After the overwhelmingly positive recommendation by the advisory committees, 49 members of Congress wrote to President Bush urging White House involvement, a move intended to supersede the FDA's authority on this matter.¹⁶ Shortly thereafter, on February 13, FDA officials notified Barr Pharmaceuticals that the agency would extend by 90 days its deadline for considering the switch to over-the-counter status.¹⁷

At this point in the process, three prominent doctors, including Alastair Wood, a professor of medicine and pharmacology at Vanderbilt University who also serves as an FDA advisory panel member, published an article in The New England Journal of Medicine, stating that, "FDA's decision-making process is being influenced by political considerations." As the authors noted, such political considerations have normally been kept out of the decision-making process at the FDA. Prior to this case, they write, approval has always been "based on scientific evidence from well-designed clinical trials with adequate power to establish efficacy and rule out toxicity at some reasonable level of confidence," adding that the agency has an obligation under U.S. law "to approve drugs for sale once their efficacy and safety have been demonstrated." In this case, they write, "there is no medical dispute" on these issues.¹⁸

Echoing these findings, Dr. Paul Blumenthal, a respected obstetrician-gynecologist at The Johns Hopkins Hospital in Baltimore, says Plan B meets all the scientific criteria for an over-the-counter drug: it is not toxic, there is no potential for addiction or abuse, and there is no need for medical screening. Commenting on Galson's "not approvable" decision, Blumenthal says, "What the FDA has just done is deny access to an important pregnancy preventive agent to millions of women." As he puts it: "This is nothing but politics trumping science."¹⁹

Former FDA officials told The New York Times that they could not remember a single instance when someone in Dr. Galson's position had overruled both an advisory committee and staff recommendations. Dr. Robert R. Fenichel, who left the agency in 2000 after 12 years, for instance, called the action "simply unheard of."²⁰

As FDA advisory panel member Trussell charges, "Unfortunately, for the first time in history, the FDA is not acting as an independent agency but rather as a tool of the White House." Trussell adds, it is "a very sad day when politicians start making medical decisions."²¹

In an attempt to address the FDA's purported medical concerns about young adolescents, the drug manufacturer Barr Pharmaceuticals resubmitted its application to the FDA, proposing that the pills be available to girls 16 and younger only with a doctor’s prescription. The FDA, however, failed to act on the resubmission, prompting concern from scientists that the approval process was again subject to abuse.

In April 2005, Senator Hillary Clinton (D-NY) announced that she would work with Senator Patty Murray (D-WA) to hold up the nomination of Lester M. Crawford to lead the Food and Drug Administration (FDA) until the agency released a decision on over-the-counter approval of the drug. 

Senators Clinton and Murray made the announcement after a meeting with Crawford that was prompted by the FDA’s long failure to act on emergency contraception drugs. Both senators indicated that a major reason for their hold on Crawford’s nomination is the fact that politics trumped science on the issue.

"I'm prepared to hold [the nomination] for as long as it takes to get a decision made," Senator Clinton said, as reported in the New York Times. She added, "From everything we're able to determine, the agency has substituted politics and ideology for science and facts." Read the entire article.

Note:This page is an excerpt from the February 2004 UCS report Scientific Integrity in Policymaking and subsequent updates.

1. Galson, S. 2004. Comments presented at a U.S. Food and Drug Administration (FDA) press conference. May 7.
2. FDA. 2003. “Transcript of the December 16, 2003 meeting of the FDA Nonprescription Drugs Advisory Committee in Joint Session with the Advisory Committee for Reproductive Health Drugs.” December 16. Available online at http://www.fda.gov/ohrms/dockets/ac/03/transcripts/4015T1.DOC.
3. Barr Pharmaceuticals, Inc. 2004. “Barr Receives Not Approvable Letter for Over-the-Counter Emergency Contraceptive.” Press release. May 6. Available online at http://www.barrlabs.com/pages/nprpr.html.
4. Galson, S., acting director of the FDA Center for Drug Evaluation. 2004. Letter to Barr Pharmaceuticals, Inc. NDA 21-045/S-011. May 6. Available online at http://www.fda.gov/cder/drug/infopage/planB/planB_NALetter.pdf.
5. FDA. 2003. “Transcript of the December 16, 2003 meeting of the FDA Nonprescription Drugs Advisory Committee in Joint Session with the Advisory Committee for Reproductive Health Drugs.” December 16. Available online at http://www.fda.gov/ohrms/dockets/ac/03/transcripts/4015T1.DOC.
6. Ibid.
7. Ibid.
8. March of Dimes. 2002. “Facts You Should Know About Teenage Pregnancy.” March. Available online at www.marchofdimes.com/professionals/681_1159.asp.
9. American Academy of Pediatrics. 2004. “Plan B Should Be Over-the-Counter for Adolescents.” Press release. May 27. Available at http://www.aap.org/advocacy/washing/Plan_B.htm.
10. Drazen, J.M. et al. 2004. “The FDA, Politics, and Plan B,” The New England Journal of Medicine 350(23):2413-2414. Correspondence. June 3. Excerpt available online at http://content.nejm.org/cgi/content/short/350/23/2413.
11. Interview with James Trussell, May 2004, for UCS Scientific Integrity report.
12. Ibid.
13. As quoted in Neergaard, L. 2004. “FDA rejects OTC morning-after pill sales,” Associated Press. May 6.
14. Galson, S. 2004. Comments presented at a U.S. Food and Drug Administration (FDA) press conference. May 7.
15. See Kaufman, M. 2004. “FDA rejects over-the-counter ‘Plan B’,” The Washington Post. May 7.
16. See Kaufman, M. “Debate Intensifies Over ‘Morning After’ Pill,” The Washington Post. February 13.
17. See Barr Laboratories, Inc. 2004. “Barr Says FDA Extends Plan B Emergency Contraceptive PDUFA Date.” Press release. February 13. Available online at http://www.barrlabs.com/pages/nprpr.html.
18. Drazen, J.M. et al. 2004. “The FDA, Politics, and Plan B,” New England Journal of Medicine 350(15):1561-1562. Editorial. April 8. Excerpt available online at http://content.nejm.org/cgi/content/short/350/15/1561.
19. As quoted in Graham, J. 2004. “’Morning after’ pill restricted by FDA,” Chicago Tribune. May 7.
20. See Harris, G. “Morning-after-pill ruling defies norm,” The New York Times. May 8.
21. Interview with James Trussell, May 2004, for UCS Scientific Integrity report. See also Kemper, V. 2004. “FDA: Doctor must still OK ‘morning-after’ pill,” Los Angeles Times. May 7.