NOTE: The following is one of a series of case studies produced by the Union of Concerned Scientists' Scientific Integrity Program between 2004 and 2010 to document the abuses highlighted in our 2004 report, Scientific Integrity in Policy Making.
The Food and Drug Administration (FDA) repeatedly placed ideological and political considerations over scientific evidence in its handling of the emergency contraceptive drug Plan B’s switch from prescription to over-the-counter (OTC) access. In 2004, in opposition to the opinions of FDA scientific staff and scientific advisory committees, the FDA denied the drug manufacturer’s application to make Plan B available for OTC use (giving the drug non-prescription status) without age restrictions. The FDA also denied OTC use by women 16 years and older and then 17 years and older, eventually restricting OTC access to women 18 years and older.
Plan B is an emergency contraceptive containing levonorgestrel, a synthetic progestin.¹ When taken within 72 hours after unprotected intercourse or contraceptive failure, preferably as soon as possible, Plan B can safely and effectively prevent pregnancy.² Some conservatives and religious groups oppose the use of Plan B, believing that greater access to Plan B would result in increased promiscuity in young women.³
FDA denial of unrestricted OTC access to Plan B
The FDA approved Plan B for prescription-only use in 1999. In February 2001⁴ the FDA received a petition from over 70 medical and public health organizations⁵ asking FDA to approve unrestricted OTC access to Plan B.⁶ In April, 2003, Barr Pharmaceuticals, Plan B’s manufacturer, submitted an application requesting Plan B’s switch to unrestricted non-prescription access.⁷
In December 2003 at a joint meeting of two FDA scientific advisory committees, the committee members voted 23 to 4 to approve the Plan B OTC switch. The members also voted unanimously that Plan B was safe for non-prescription use.⁸
In May 2004, contrary to the advice of the scientific advisory committees, Dr. Steven Galson, the acting Director for the Center for Drug Evaluation and Research (CDER), the center within the FDA that reviews drug switches from prescription to OTC status,⁹ issued a letter denying Barr Pharmaceuticals’ OTC switch application.¹⁰ It was the only time in the span of ten years that an OTC switch was denied against the recommendation of the advisory council.¹¹
In the process of making a decision regarding Plan B, the White House and the FDA commissioner’s office wrongly pressured FDA staff into denying the OTC switch application, the FDA commissioner appointed scientific advisory committee members based on ideology and not scientific expertise, and the FDA did not base its decision on scientific evidence.
White House and FDA Commissioner interference
As evidenced by court testimonies, political interference in the decision not to approve Plan B for unrestricted OTC access reached the level of White House intervention.¹² Dr. Woodcock, then-FDA Acting Deputy Commissioner, and Galson informed Dr. Jenkins and Dr. Sandra Kweder, Deputy Director of the Office of New Drugs at the FDA, that Plan B was not going to be approved and that the decision was going to be made at a higher-than-normal level within the FDA.¹³
Woodcock told Kweder that former FDA Commissioner McClellan had made his decision with White House involvement and that "there were a lot of constituents who would be very unhappy with….an over-the-counter Plan B." Woodcock informed another FDA staff member that the OTC switch denial was the only way to "appease the [present] administration’s constituents."¹⁴ In a January 2004 letter to former President Bush, 49 conservative members of Congress urged the President to deny the application for OTC use, mainly because they were concerned about teenage use of the drug.¹⁵
Evidence also indicates that former Commissioner McClellan influenced both Woodcock’s and Galson’s opinions. Dr. Jenkins testified that "Dr. Galson…told me that he felt that he didn’t have a choice, and…that he wasn’t sure that he would be allowed to remain as Center Director if he didn’t agree with the [Not-Approvable] Action."¹⁶ Dr. Susan Wood, former Assistant Commissioner for Women’s Health and Director of the FDA Office of Women’s Health, confirmed Dr. Jenkins’ testimony with her own testimony regarding her experience with Galson.¹⁷
Political interference in selecting advisory committee members
The selection of members for one of the scientific advisory committees charged with making recommendations to the FDA regarding Plan B was tainted with political and ideological interference.¹⁸ Usually, FDA review offices sent possible committee member names to the Commissioner’s office for approval. In the case of Plan B, FDA staff testified in court that former FDA Commissioner McClellan’s office appointed individuals without the normally required expertise to the advisory committee. Many of the names the Commissioner suggested shared an ideological viewpoint and were active in the "Right to Life antiabortion world."¹⁹
Further, Dr. W. David Hager, an evangelical conservative who was asked to join the FDA advisory panel by the White House, was asked to provide a "minority opinion" on why Plan B should not be sold OTC that was sent to the FDA Commissioner’s office.²⁰ In a recorded sermon from 2005, Dr. Hager claimed that he "argued from a scientific perspective, and God took that information, and he used it through this minority report to influence the decision."²¹
Denial of unrestricted OTC access was not based on scientific evidence
The decision to deny an OTC switch for Plan B was not based on scientific rationale. Court testimony from FDA staff and a 2005 Government Accountability Office report indicate that the FDA made the decision regarding Plan B before FDA’s scientific reviews were even completed.²²
In his letter explaining the denial of OTC use, Galson cited lack of adequate data on women below 16 years of age and his concerns about extrapolating data on older women to younger adolescents.²³ However, in December 2003, the scientific advisory committee voted 27 to 1 that the data submitted by the manufacturer with the switch application could be generalized to the overall population of potential Plan B users.²⁴ Of the few committee members who even questioned the data, at least two were appointed directly by the FDA Commissioner.²⁵ The drug manufacturer had also submitted extensive supplemental data to demonstrate that young adolescents could safely use Plan B.26
In addition, FDA scientific review staff strongly believed that Plan B should have been approved for OTC use for women of all ages.27 One FDA review doctor stated that the drug manufacturer proved that all women across relevant age groups "can use the product appropriately."28 In direct response to Galson’s concerns about extrapolating data, Dr. John K. Jenkins, Director of the Office of New Drugs, pointed out that the FDA "has a long history of extrapolating findings from clinical trials in older patients to adolescents."29
Galson also stated that studies submitted with the Plan B application did not adequately address young adolescent behavioral changes such as increased sexual behavior or increases in unprotected intercourse.30 Former Commissioner McClellan was also concerned about the behavioral differences between younger adolescents and older women.31
Contradicting Galson and McClellan’s concerns, an actual use study of Plan B demonstrated that unprotected sex did not increase when women had access to Plan B. In addition, many doctors working at the FDA pointed to the lack of scientific evidence that OTC access for Plan B would increase sexual promiscuity in young adolescents.32 Dr. Curtis Rosebraugh, Deputy Director of the Division of OTC Drugs at the FDA, asserted that the data about Plan B "is quite compelling to dispel any potential concerns regarding adolescent use or changes in sexual behaviors" and that if the Plan B data was not sufficient, "it is unclear what would constitute enough data or even if that is an obtainable goal."33 In addition, the FDA had not considered behavioral implications when deciding OTC switches in the past.34
FDA’s denial of OTC access for women 16 years and 17 year and older
After the FDA’s denial of OTC access without age restriction, Barr Pharmaceuticals amended their application, asking the FDA to approve OTC status for women 16 years and older in July 2004. Though many FDA scientists disagreed with any age restriction, Dr. Galson was planning on approving OTC access to women 17 years and older because he was "comfortable with the science." 35 However, in early 2005 the new Acting Commissioner, Dr. Lester Crawford, removed Galson’s authority to make such a decision.36
After indefinite delays by the FDA, Dr. Susan Wood resigned in protest from her position as assistant commissioner for women’s health and director of the Office of Women’s Health at the FDA on August 31, 2005.37 Dr. Wood stated in her resignation letter that the FDA’s decision not to approve Plan B overturned "clear scientific and clinical evidence" and denied access "to a product clearly established as safe and effective for all women who need it."38
Following further delays, the FDA, now headed by Commissioner Andrew von Eschenbach, ultimately decided Plan B would be available without a prescription only to women 18 and older in August 2006, citing that it would be difficult to enforce a 17 and older age restriction.39
Recent Developments: FDA will allow Plan B access to women 17 and older
On March 23, 2009, U.S. District Judge Edward Korman ordered the FDA to make Plan B available to women 17 and older and to reconsider its decisions regarding OTC age restrictions.40 The FDA stated that it would approve OTC access to women 17 years and older after the Plan B manufacturer submits an application,41 but that it would only review its decisions about whether any age restriction is necessary if requested by the manufacturer.42
1. U.S. Food and Drug Administration (FDA). 2009. Plan B (0.75mg levonorgestrel) and Plan B One-Step (1.5 mg levonorgestrel) Tablets Information.
2. FDA 2009.
3. Stein, R. 2007. Plan B use surges, and so does controversy. Washington Post, July 13.
4. Tummino v. Torti, No.CV-05-366 (E.D.N.Y. Mar. 23, 2009) (Korman, J.).
5. Center for Reproductive Rights. 2009. Federal Court Rules FDA Must Reconsider Plan B Decision. March 23.
6. Tummino v. Torti 2009.
7. Tummino v. Torti 2009; Galson, S. 2004. Not-Approvable letter to Barr Research, Inc. May 6.
8. Tummino v. Torti 2009; U.S. Food and Drug Administration. 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.
9. Government Accountability Office (GAO). 2005. Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B was Unusual. November 14.
10. Galson 2004.
11. GAO 2005.
12. Tummino v. Torti 2009.
13. Tummino v. Torti 2009.
14. Tummino v. Torti 2009.
15. Kaufman, M. 2004. Staff scientists reject FDA’s Plan B reasoning. Washington Post, June 18.
16. Tummino v. Torti 2009.
17. Tummino v. Torti 2009.
18. Tummino v. Torti 2009.
19. Tummino v. Torti 2009.
20. Kaufman, M. 2005. Memo may have swayed Plan B ruling. Washington Post, May 12.
21. Kaufman 2005.
22. Tummino v. Torti 2009; GAO 2005.
23. Galson 2004.
24. Tummino v. Torti 2009.
25. Tummino v. Torti 2009.
26. Tummino v. Torti 2009.
27. Tummino v. Torti 2009.
28. Tummino v. Torti 2009.
29. GAO 2005; Tummino v. Torti 2009.
30. GAO 2005.
31. Tummino v. Torti 2009.
32. Tummino v. Torti 2009.
33. Tummino v. Torti 2009.
34. GAO 2005.
35. Tummino v. Torti 2009.
36. Tummino v. Torti 2009.
37. Wood, S.F. 2005. Women’s Health and the FDA. New England Journal of Medicine, October 20.
38. Tummino v. Torti 2009.
39. Tummino v. Torti 2009.
40. Tummino v. Torti 2009.
41. FDA 2009.
42. Stein, R. 2009. 17-year-olds to gain access to Plan B pill. Washington Post, April 23.