In what sexual and reproductive health and rights advocates consider to be a major victory for women's health, the U.S. Federal Food and Drug Administration (FDA) announced on August 25, 2006 its approval of over-the-counter (OTC) access to Plan B emergency contraception for women 18 years and older. Unfortunately, young women 17 years and younger will continue to need a prescription from their doctor. The scientific community does not consider the age restriction to be medically justified.
Plan B, a brand of emergency contraceptive pills currently available only by prescription, is a high dose of regular birth control pills that if taken within 72 hours of unprotected sex can lower the risk of pregnancy by up to 89 percent. Barr Laboratories' application to make Plan B available without a prescription has been pending before the FDA for more than three years. In 2001, the FDA's own expert staff and advisory panels overwhelmingly voted to make Plan B available OTC. OTC status is also favored by the American Medical Association (AMA), the American Academy of Pediatrics (AAP), the American College of Obstetricians and Gynecologists (ACOG), and more than 70 other medical and public health organizations.
On July 31, 2006, the Food and Drug Administration (FDA) announced that it would soon make emergency contraception available without a prescription to women over the age of 18. One week later, the federal agency held a meeting with the drug's manufacturer to discuss the manufacturer's application. The FDA stunned Barr Laboratories , the maker of Plan B, and advocates for over-the-counter access to emergency contraception with the announcement that it would reevaluate the long-delayed decision—with some caveats. The FDA said it would now only consider non-prescription sales of the pill called Plan B for women 18 years old and older, and demanded details on how Barr would ensure that pharmacies enforced that age restriction.
The approval came after the agency, in May 2004, issued a “not approvable” letter in response to an application submitted by Plan B's original manufacturer, Women's Capital, for nonprescription sales of Plan B (Barr purchased Women's Capital during consideration of the application). In the “not approvable” letter, the FDA cited inadequate data on Plan B's use among girls younger than age 16, and Barr subsequently submitted a revised application to make the drug available without a prescription only to girls and women ages 16 and older. In a July 31 st letter to Barr, acting FDA Commissioner Andrew von Eschenbach wrote that 18 is the “appropriate age” to allow women to buy Plan B without a prescription and asked Barr to raise the age restriction in its application from 16 to 18. Barr resubmitted its application with the higher age restriction the following week.
FDA Center for Drug Evaluation and Research Director Steven Galson said the agency decided on 18 for the age restriction because there are “all kind[s] of age restrictions that click in at that age”—including sales of tobacco and nicotine replacement treatments. However, the American College of Obstetricians and Gynecologists said in a statement that “there is no scientific or medical reason to impose an age restriction and to withhold EC from this population” and that “minors will continue to potentially face difficulty in obtaining Plan B and that the “FDA has missed an unparalleled opportunity to prevent teenage pregnancies.”1
Many viewed the most likely explanation for the unexpected approval to be one of political maneuvering as the Senate was scheduled to vote on the nomination of the FDA's acting commissioner, Dr. Andrew C. von Eschenbach the day after the July 31 st announcement that approval was near. Senators Hillary Rodham Clinton (D-NY) and Patty Murray (D-WA) had placed a hold on von Eschenbach's nomination, saying that they would only allow a vote to go forward if a decision—yes or no—was issued on the Plan B application. Under Senate rules, any senator may place a ‘‘hold' on a floor vote to approve a nominee.
Senators Clinton and Murray had placed a similar hold on von Eschenbach's predecessor, former commissioner Lester Crawford. Crawford received the Senate's nod in the summer of 2005 only after assuring Senators Clinton and Murray that a final decision on Plan B would be made by September 1, 2005. Going against his own word, Crawford announced on August 26, 2005 that the decision would be further delayed. He explained that although OTC sales to women 17 and older would be safe, younger teens would still need a prescription due to concerns of their capacity to utilize the drug properly.2
Prior to the FDA's announcement of approval, Senator Murray said, “Fool me once. We are not going to go there again. We will hold this nomination until we have a decision on Plan B.” While calling the timing of the announcement “highly suspect behavior,”3 Senators Clinton and Murray said of the approval, “this long overdue decision is a victory for women's health and for the American people who have been waiting for years for the FDA to act. While we urge the FDA to revisit placing age restrictions on the sale of Plan B, it is real progress that millions of American women will now have increased access to emergency contraception. It is also an important step in restoring the American people's faith in the FDA by demonstrating that the agency will return to its mission of putting science ahead of ideology.” They added, “as promised, we will lift our hold on the nomination of Acting FDA Administrator von Eschenbach and hope that he will provide the strong scientific leadership the FDA needs and deserves.”4
Many sexual and reproductive health and rights groups expressed bittersweet sentiments about the announcement that over-the-counter sales of EC was finally approved. Several organizations hailed the approval for women 18 years and older as a significant victory for women's health while expressing disappointment and concern that the age restriction will leave young women, those under the age of 18 years old, without access to the emergency contraceptive option.
“While SIECUS applauds the FDA's decision, we remain disappointed that over-the-counter access to Plan B was not approved for women of all ages. As the scientific evidence has shown, this arbitrary age restriction is medically unjustified,” said Joseph DiNorcia, President and CEO of SIECUS. “The FDA missed a real opportunity to help reduce the high rate of teen pregnancy that continues to persist in the U.S. SIECUS urges the FDA to look at the evidence and move quickly to lift this age restriction,” DiNorcia continued.
Reproductive Health Technologies Project, a leader in the fight for over-the-counter access to emergency contraception, agreed, stating that, “while this is a triumph for most women, young women 17 years and under are left behind. Restricting OTC access will come at a real cost to these women who will have to jump through hoops for this treatment, thereby delaying access and making it less effective. Studies show that increased access to emergency contraception does not cause teen promiscuity or other health risk behaviors. With the almost 300,000 pregnancies occurring each year in this country among women under 18, OTC access to Plan B for teens is a common sense next-step in a larger strategy to reduce unintended teen pregnancy.”5
On the other hand, anti-choice groups are urging President Bush to withdraw his nominee to head the Food and Drug Administration, angry that the agency allowed nonprescription sales of Plan B. Now that Senators Clinton and Murray have lifted their hold on his confirmation, Von Eschenbach's confirmation next month is expected to be approved by the full Senate. “If the president pushes for this nominee, he is only going to undercut the support his own party needs in the elections,” said Paul Chaim Schenck, director of the National Pro-Life Action Center.6
Tony Perkins, director of the Family Research Council followed suit, saying that, “Family Research Council and other strong supporters of President Bush's policies on health and life issues have opposed OTC status for Plan B. Apparently, this has fallen on deaf ears. The White House is allowing Senators Hillary Clinton (D-NY) and Patty Murray (D-WA) to determine medical and social policy in America.” The Family Research Council (FRC) announced in a release that it is “pursuing legal and legislative options against the FDA for its deliberate disregard for women's health and the law.”7
Advocates for full over-the-counter access are also pursuing legal options. The Center for Reproductive Rights has said that it will continue its lawsuit against the FDA over its rejection of Barr's first application for nonprescription Plan B sales.8 In a recent deposition in the case, John Jenkins, director of the FDA's Office of New Drugs, said that Galson told him “that he felt he didn't have a choice” but to reject Barr's original application. Jenkins added that Galson “characterized that in a sense that he wasn't sure that he would be allowed to remain as center director if he didn't agree with the action.”9 Lead attorney for the Center for Reproductive Rights, Simon Heller, said that the Center will seek to have the age restriction for nonprescription Plan B sales overturned through the lawsuit.10
- American College of Obstetricians and Gynecologists, “ Statement of The American College of Obstetricians and Gynecologists On the FDA's Approval of OTC Status for Plan B®,” Press Release published 24 August 2006, accessed 25 August 2006, <http://www.acog.org/from_home/publications/press_releases/nr08-24-06.cfm>.
- For more information, see previous policy update “ Politics of Emergency Contraception Continue.”
- “Morning-after pill entangles Bush's FDA nominee,” Associated Press , 1 August 2006.
- “Senators Clinton and Murray Applaud FDA Decision on Plan B,” Press Release published on 24 August 2006, accessed 25 August 2006, <http://clinton.senate.gov/news/statements/details.cfm?id=262021&&>.
- Reproductive Health Technologies Project, “ RHTP Celebrates Victory in Plan B ® OTC Approval ,” Press Release published 24 August 2006, accessed 25 August 2006, <http://rhtp.org/documents/RHTPPressReleasePlanBAPPROVAL.pdf>.
- Andrew Bridges, “Anti-abortion groups call on Bush to withdraw nominee to lead FDA,” Associated Press, 17 August 2006.
- Nathan Burchfiel, “ Family Group Plans Legal Challenge To ‘Plan B' Decision,” CNSNews.com, 24 August 2006, Accessed 25 August 2006, <http://www.cnsnews.com/news/viewstory.asp?Page=/Culture/archive/200608/CUL20060824b.html>.
- For more information, see previous policy update “ Former FDA Commissioner Testifies .”
- Gardiner Harris, “ F.D.A. Approves Broader Access to Next-Day Pill,” New York Times, 25 August 2006, accessed 25 August 2006, <http://www.nytimes.com/2006/08/25/health/25fda.html>.
- Judith Graham , “Plan B cap lifted,” Chicago Tribune , 25 August 2006, accessed 25 August 2006, <http://www.chicagotribune.com/features/health/chi-