Department of Health and Human Services (HHS) Secretary Kathleen Sebelius shocked women’s health and reproductive rights advocates by overruling the decision of the Food and Drug Administration (FDA) to make the emergency contraception method known as Plan B One-Step available for purchase without a prescription or age restriction. Plan B One-Step, a single dose medication commonly referred to as the “morning-after pill,” has been proven safe and effective to reduce the chance of pregnancy if taken within 72 hours of unprotected sexual intercourse.

 

After years of drawn-out decision-making, Plan B One-Step was approved for sale without a prescription to women ages 17 and older in 2009. In February 2011, Plan B One-Step’s manufacturer, Teva Women’s Health Inc., submitted “a supplemental application seeking to remove the prescription-only status for females younger than age 17 and to make Plan B One-Step nonprescription for all females of child-bearing potential.”[1] FDA commissioner Margaret Hamburg, M.D., was prepared to announce that the agency had approved Teva’s supplemental application on December 7, 2011; however, Secretary Sebelius notified Dr. Hamburg that morning of her intention to take the unprecedented step of superseding the FDA’s purview and denying Teva’s application.

 

The FDA first approved a multidose version of Plan B for sale to consumers by prescription only in 1999. The drug contains a synthetic form of progesterone, the hormone commonly found in oral contraceptives, but in a higher dosage. Plan B’s manufacturer originally petitioned the FDA to make Plan B available for purchase over the counter in 2003; however, that application was denied despite the fact that “an FDA expert advisory panel voted 23 to 4 in favor of the switch” due to the agency’s concern that it had insufficient information about the drug’s effect on women ages 16 and under.[2]

 

Plan B’s manufacturer then petitioned the agency for permission to sell Plan B over the counter to women ages 17 and older at the behest of FDA officials. In response, then FDA commissioner Lester Crawford ruled in 2005 that the agency lacked the authority to approve the drug for over-the-counter use only for women ages 17 and older. That decision prompted the resignation of Susan F. Wood, the FDA’s assistant commissioner for women’s health, who was concerned that the “scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, [was] overruled.”[3] The FDA approved the sale of Plan B without a prescription to women ages 18 and over in 2006, but was compelled three years later by a federal judge to lower the age restriction to 17.[4] While evaluating Teva’s 2011 application to remove the age restrictions on Plan B One-Step, the FDA’s Center for Drug Evaluation and Research:

 

determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use . . . that the product would not protect them against sexually transmitted diseases . . . [and] that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.[5]

 

On the basis of those findings as well as other professional consultations, Commissioner Hamburg ascertained that “there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”[6]

 

“For years, experts have agreed there was no scientific or medical rationale for age restrictions on emergency contraception,” comments Monica Rodriguez, president and CEO of the Sexuality Information and Education Council of the United States. “For far too long, young people’s and women’s health has been at the whim of politically driven decision-makers and Secretary Sebelius’s decision is no exception. Keeping emergency contraception behind the pharmacy counter was and remains a politically motivated decision that only serves as a major barrier to accessing a time-sensitive product. The decision to block reclassification of emergency contraception to over-the-counter status for all women will undoubtedly continue to hinder women’s access to this effective method of contraception.”

 

Keeping Plan B One-Step behind the pharmacist’s counter restricts access for everyone, not just people under the age of 17. Women without access to a pharmacy that is open 24 hours a day, seven days a week, may face a delay in obtaining Plan B One-Step because the pharmacy is closed. In addition, a pharmacist may refuse to sell Plan B One-Step without a prescription to women of all ages who lack identification. Many women face obstacles in obtaining a prescription, including difficulty getting an appointment with a physician in a timely manner, the cost associated with an office visit, and lack of access to transportation. Finally, many states allow pharmacists to refuse to provide emergency contraception at all if they believe it is in conflict with their religious beliefs. 

 

Secretary Sebelius’s decision to overrule the FDA and retain the age restrictions on Plan B One-Step prompted swift backlash from policymakers and advocates. A group of 14 senators, led by Patty Murray (D-WA), sent a letter to Secretary Sebelius expressing their disappointment with her decision and asking that she explain the “specific rationale and the scientific data you relied on for the decision to overrule the FDA recommendation.”[7] In addition, advocates plan to reopen the litigation that led to the previous lowering of the Plan B One-Step age restrictions.

 

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