SIECUS Logo

Support SIECUS!

Make sexuality education available to all.

Stay informed!

Sign up for SIECUS newsletters, updates, action alerts, and more!

Quick Links

PrEP
May 2004 (To print, click the print icon on your browser
or choose print from the menu)


Politics or Science? FDA Denies Emergency Contraception Over-the-Counter Application

Disregarding the recommendation of two of its own advisory committees, the U.S. Food and Drug Administration (FDA) rejected Barr Laboratories' application to make Plan B emergency contraception available to consumers over-the-counter (OTC) without a prescription.

The FDA's rejection of Barr's application, after it received overwhelming support from both the health professionals and the FDA's advisory committees, was unprecedented. In December 2003, two FDA advisory committees recommended 23 to 4 that Plan B be made available OTC with no restrictions. A decision regarding the switch to OTC status from prescription-only had been expected by February 20. However, the FDA requested and received a 90-day extension to continue its review, and subsequently issued the "Not Approvable" letter in May. Despite the endorsement of the advisory committees, and over the additional recommendation of his own staff, acting director of the FDA's Center for Drug Evaluation and Research, Dr. Steven Galson, personally signed the "Not Approvable" letter rejecting the application.

"I can't ever remember the center director ever signing a nonapprovable letter," said Dr. Raymond Lipicky, who held a top agency position for 18 years.1

Dr. Galson himself admits that his involvement in the decision was atypical, saying, "I am not trying to convey this decision as being common or usual."

Throughout the FDA's review process, health advocates have expressed concern that politics were influencing the FDA's decision. "The FDA is supposed to make risk-benefit decisions about the public health, and it was absolutely clear that women would be best served by easier access to emergency contraception,"2 said Kirsten Moore, President of the Reproductive Health Technologies Project.

Rep. Louise Slaughter (D-NY), co-chair of the bipartisan Congressional Pro-Choice Caucus, has led a congressional effort to have the FDA decision revisited and has called for the resignations of FDA Acting Commissioner Lester Crawford and Dr. Galson. In a letter to President Bush, Rep. Slaughter wrote, "The integrity of the FDA drug approval system, and of public confidence in the safety and efficacy of the drugs FDA approves, depends on these decisions being free from political influence. American women - indeed, all Americans - trust the FDA to make the best decisions possible with respect to their health… Unfortunately, the FDA's decision on Plan B has shattered this trust, especially in the leadership at the FDA."3

In her letter, Rep. Slaughter also cited an editorial written by two members of the FDA advisory committees that considered the application. Published in the New England Journal of Medicine in April following the FDA's request for an extension, the editorial echoes concerns that the FDA's decision was being influenced by politics. "The recent decision by the Food and Drug Administration (FDA) to postpone a decision on the proposal to switch levonorgestrel emergency contraception (sold under the brand name Plan B) to over-the-counter status suggests that the FDA's decision-making process is being influenced by political considerations… A treatment for any other condition, from hangnail to headache to heart disease, with a similar record of safety and efficacy would be approved quickly."4

In the "Not Approvable" letter issued to Barr, the FDA cited a perceived lack of data regarding use of Plan B by young women under the age of 16 as its primary reason for rejecting the application. Opponents of making emergency contraception available without a prescription often express similar concerns, arguing that access to Plan B will encourage adolescent sexual promiscuity and sexual risk-taking, despite evidence that this has not been the case when emergency contraception is made easily available to young people.

"The worst-case scenario is that you've got a young couple and they would normally use a condom when they were having intercourse, but since they know they can run to the CVS to get Plan B, are they going to worry about that?" imagined Dr. Galson.5

Health advocates agree that data regarding use of Plan B by very young women is limited, but site different reasons. "Yes, the data on women 16 and under is limited, but that's because use is very limited," Kirsten Moore said.6

When the FDA advisory committees met in December they unanimously agreed that no data shows that non-prescription availability of Plan B leads to a substitution of emergency contraception for a regular contraceptive method. Further, they noted that increased access to emergency contraception is not associated with increased risk for STDs or pregnancy in young women.

"People are just hopping mad," said Michael Greene, a Harvard University OB/GYN who served on the FDA's Reproductive Health Drugs Advisory Committee, referring to his fellow committee members. "The decision is blatantly contrary to the science and the facts and so blatantly politicized."7

Given that emergency contraception can reduce the risk of pregnancy by up to 89 percent if taken within 72 hours of unprotected sexual intercourse, and is most effective within the first 24 hours, timely access to this back-up contraceptive option is imperative. Plan B is currently available from a pharmacist without a prescription in Alaska, California, Hawaii, New Mexico, and Washington State.

"Emergency contraception represents a major breakthrough in public health," said Tamara Kreinin, president and CEO of the Sexuality Information and Education Council of the United States (SIECUS). "Reclassifying EC to over-the-counter status would undoubtedly increase women's access to this important method of contraception and have a tremendous impact on improving the health of women. However, the Bush Administration has, once again, chosen to put its conservative ideology ahead of women's health."

The FDA did leave Barr Laboratories with two options for continuing to pursue over-the-counter-status for Plan B. One option is to provide additional data that young women under 16 can safely use Plan B without professional supervision. Or, the drug could be marketed as a prescription drug for women ages 16 and younger, but be available without a prescription for women over the age of 16. Such a dual marketing strategy would be unprecedented, however, and the onus would be on Barr to devise and implement the approach.

Despite the setback, Barr Laboratories remains committed to improving access to Plan B. "Clearly we're disappointed," said Bruce Downey, Barr CEO, "but the FDA has also provided us with pathways to a future approval, and we are committed to following the pathways until we get this product on the market over-the-counter."8

As co-sponsors of the Back Up Your Birth Control campaign, and supporters of increased access to emergency contraceptive options, including the approval of Plan B emergency contraception as an over the counter option, SIECUS will continue to provide timely updates on the FDA approval process.

Read the FDA's "Not Approvable" letter to Barr Laboratories.

Learn more about the Back Up Your Birth Control campaign.

References

  1. G. Harris, "Morning-After-Pill Ruling Defies Norm," The New York Times, May 8, 2004.
  2. M. Kaufman, "Plan B Won't Be Sold Over Counter," The Washington Post, May 7, 2004.
  3. "Slaughter Calls on President Bush to Fire Leadership at FDA for Controversial Emergency Contraception Decision," press release dated June 3, 2004. Accessed online.
  4. "Slaughter Calls on President Bush to Fire Leadership at FDA for Controversial Emergency Contraception Decision," press release dated June 3, 2004. Accessed online.
  5. G. Harris, "Morning-After-Pill Ruling Defies Norm," The New York Times, May 8, 2004.
  6. M. Kaufman, "Plan B Won't Be Sold Over Counter," The Washington Post, May 7, 2004.
  7. "FDA Official Rejected OTC Status for EC Plan B Against Advice of Own Staff, Says Decision Not Based on Politics," KaiserFamily Foundation. Available online.
  8. M. Kaufman, "Plan B Won't Be Sold Over Counter," The Washington Post, May 7, 2004.

National Coalition to Support Sexuality Education National Coalition to Support Sexuality Education