Teva Pharmaceuticals, the manufacturer of the emergency contraceptive Plan B One-Step, has filed an application to the U.S. Food and Drug Administration (FDA) to allow over-the-counter availability of the emergency contraceptive Plan B without an age restriction.[1] Currently, the minimum age at which an individual can purchase Plan B over the counter is 17; those under the age of 17 must obtain Plan B via a prescription from a doctor.[2] Approval of the application by the FDA would remove this barrier to immediate access to emergency contraceptive care, helping to ensure that those under the age of 17 also have timely access to this contraceptive method.

 

Plan B is a high dose of regular birth control pills that can be a safe and effective method of preventing unintended pregnancies if taken up to 72 hours after unprotected intercourse. In August 2006, the FDA approved Plan B as an over-the-counter contraceptive for women 18 and older. Under the FDA guidelines, the age restriction is monitored closely by pharmacists, as Plan B is stored behind pharmacy counters and identification is required to verify each consumer’s age.[3]

 

The FDA has cited a perceived lack of data regarding use of Plan B by young women under the age of 16 as its primary reason for age restrictions on OTC distribution. 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.[4]

 

Teva Pharmaceuticals’ application closely follows the Center for Reproductive Rights’ (CRR) recent decision to take the FDA to court for limiting OTC access to Plan B. CRR filed a motion for contempt of court on November 16, 2010, citing a March 2009 ruling by the U.S. District Court for the Eastern District of New York. In this ruling, Judge Edward Korman found that the FDA’s decision to exclude women under 17 from over-the-counter access to Plan B was based on politics and not on science, and directed the agency to extend over-the-counter access to 17 year-olds.[5]

 

Teva’s filing of the application to remove the age restriction on over-the-counter sale and distribution of Plan B One-Step is only the latest chapter in a more than ten-year history of the struggle between emergency contraception and the FDA. Advocates for sexual and reproductive freedom have long criticized the FDA for using its position to make political statements regarding the sexual activity of women, young or old, who wish to engage in sexual activity free from a heightened risk of unintended pregnancy. In one instance of this, Dr. W. David Hager, an obstetrician and former member of the FDA’s Advisory Committee for Reproductive Health Drugs, explained his vote against FDA approval of Plan B’s over-the-counter status with the following comments: “What we heard today was frequently about individuals who did not want to take responsibility for their actions and wanted a medication to relieve those consequences.”[6]

 

Experts agree there is no scientific or medical rationale for age restrictions on emergency contraception. Even the FDA’s own advisory committees voted unanimously that there was substantial evidence that Plan B would be safe for use as an over-the-counter drug and voted 23–4 to change the status of Plan B to nonprescription with no restrictions in December 2003. The FDA finally announced in August 2006 its approval of over-the-counter access to Plan B emergency contraception for women 18 years and older, and Judge Korman’s 2009 ruling lowered that age to 17.

 

According to CRR, “No drug besides Plan B is subject to a two-tiered prescription/over-the-counter structure based on age. And no other over-the-counter [contraceptive] requires production of identification for purchase. The testimony of FDA employees and officials makes clear that the FDA’s decisions were made on the basis of politics, rather than on considerations of the drug’s safety and efficacy.”[7] The 2010 CCR motion was in response to a year and a half of inaction on the part of the FDA after Judge Korman’s ruling.

 

Emergency contraceptives can act as a safe and highly effective method of pregnancy prevention if taken within the first few days of contraceptive failure or unprotected sexual intercourse; however, the effectiveness decreases as the amount of time after contraceptive failure or unprotected sex increases. 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; therefore, timely access to the back-up contraceptive option is imperative. The requirement of a prescription for women under the age of 17— and the extra time it takes to obtain a prescription relative to purchasing the emergency contraceptive over the counter at a pharmacy—can place these individuals at a higher vulnerability to unwanted pregnancy.

 

The FDA has set the time period for its review of Teva’s application at ten months, citing a need to examine the new data Teva has provided, at the FDA’s request, on teen usage of Plan B One-Step.[8] This request came in spite of the repeated insistence of FDA reviewers during the original review process that “there was no medical or scientific need for new data on younger teens” for Plan B to go over-the-counter.[9]

 

Nancy Northrup, president of CRR, agrees, saying, “There’s enough scientific evidence before the agency to decide whether to make Plan B available over-the-counter, and there has been for ten years.”[10] The FDA’s sudden “need” for more data in order to consider the removal of the arbitrary age restriction therefore appears to be nothing more than another politically motivated obstacle. It could also have dangerous implications, as highlighted by Susan Wood, an associate professor at the School of Public Health and Health Services at George Washington University and board member of the Reproductive Health Technologies Project: “I hope this process does not set a precedent at the FDA for new data as a condition of approval for [over-the-counter] access by teens under 17.”[11]

 

“If the FDA wants to live up to its reputation as an organization founded in science and clinical data rather than one rooted in biased ideology, it will approve Teva Pharmaceuticals’ application to sell Plan B One-Step over the counter without age restrictions,” comments Jen Heitel Yakush, director of public policy for the Sexuality Information and Education Council of the U.S. (SIECUS). “Having Plan B be available over the counter for women of all ages makes good public health sense. The FDA has too long delayed unrestricted access to emergency contraception and should follow the recommendations of its own scientists and lift the unjustified age-restriction immediately.”

 

 

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