Plan B, One Step not taken: politics trumps science yet again by Ipas México

Contraception 85 (2012) 340 – 341

Commentary

Plan B, One Step not taken: politics trumps science yet again☆ Kelly Cleland a,⁎, Jeffrey F. Peipert b , Carolyn Westhoff c, d, e , Scott Spear f , James Trussell a, g a Office of Population Research, Princeton University, Princeton, NJ 08554, USA Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, MO 63110, USA c Department of Obstetrics and Gynecology, Columbia University, New York, NY 10032, USA d Department of Epidemiology, Columbia University, New York, NY 10032, USA e Department of Population and Family Health, Columbia University, New York, NY 10032, USA f Planned Parenthood of the Texas Capital Region and Planned Parenthood of Central Texas, Austin, TX 78794, USA g The Hull York Medical School, University of Hull, HU6 7RX Hull, United Kingdom b

Received 19 December 2011; accepted 20 December 2011

In a stunning move on December 7, Secretary of Health and Human Services Kathleen Sebelius overruled the Food and Drug Administration's judgment that the levonorgestrelcontaining emergency contraceptive pill (ECP) Plan B OneStep should be approved for full nonprescription status without an age restriction [1]. FDA Commissioner Margaret Hamburg announced on the same day that the Center for Drug Evaluation and Research (CDER) had closely reviewed the evidence that Plan B One-Step is safe and effective for women of all ages, including data demonstrating that younger adolescents are sufficiently able to understand how to use the product safely without consulting a health care provider [2]. However, in a maneuver unprecedented in the history of the FDA, Secretary Sebelius unilaterally superseded the authority of the Commissioner and ordered that the agency deny the application. Despite the fact that the panel of experts at CDER, which included obstetrician–gynecologists and pediatricians, determined that the data met the regulatory standard for a nonprescription drug, Secretary Sebelius based her rejection of the application on the rather vague argument that it is “common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age” [1]. Instead of being available on pharmacy shelves alongside condoms, nonprescription Plan ☆ This commentary reflects the views of and has been endorsed by the Society of Family Planning. ⁎ Corresponding author. Office of Population Research, Princeton University, Princeton, NJ 08544, USA. Tel.: +1 609 258 1395; fax: +1 609 258 1039. E-mail address: kcleland@Princeton.edu (K. Cleland).

B One-Step must still be obtained from a pharmacist and only by women or men aged 17 years and over. Secretary Sebelius's rejection of the application on unsubstantiated concerns about misuse among younger adolescents echoes the arguments of Bush appointee Dr. David Hager during the 2003 FDA hearing on the first application to move Plan B to nonprescription status, who said “I don't think that the actual use study gives us adequate information for that younger adolescent population” [3]. It must be noted, however, that medications with actual evidence of potential harm in the event of misuse (in contrast to Plan B One-Step, for which there is no evidence whatsoever), such as aspirin, acetaminophen and cough medicine containing dextromethorphan [4,5], are sold on the shelf without age restriction and have historically been approved for such sale without requirements for safety data for specific age groups. We contend that the double standard for EC is motivated entirely by political, not medical, considerations. President Obama denies involvement in the decision, but voiced his support “as the father of two daughters.” It is a profound disappointment that the Obama Administration has chosen to follow the lead of President Bush in allowing political considerations to take precedence over the scientific judgment of experts within the FDA. As in 2004, when the application of the Women's Capital Corporation for nonprescription status for Plan B was denied despite overwhelming support from the FDA advisory committee and the approval of the FDA reviewing divisions normally responsible for making decisions on an over-the-counter switch, once again political judgment is central in decision making about EC.

Commentary / Contraception 85 (2012) 340–341

What has been lost in this missed opportunity? The American Academy of Pediatrics, the Society for Adolescent Health and Medicine, and the American College of Obstetricians and Gynecologists all agree that Plan B OneStep is safe and effective for adolescents and should be available without restriction to women of all ages. But the focus on the youngest adolescents is a distraction and a convenient political excuse for inaction. Secretary Sebelius notes that about 10% of girls experience menarche by 11.1 years of age, but fails to note also that (based on reports from females b25 years old in the 2006–2010 National Surveys of Family Growth) only an estimated 0.6% of 11-year-olds have had sex (Finer L. Personal communication to J.T., December 12, 2011.). Keeping a prescription requirement for those aged 16 and younger certainly restricts access to ECPs: getting a prescription within 3 days of unprotected sex (the product is labeled for use only up to 72 h) poses a formidable challenge. The reality is that this decision has an impact on ALL women, not only those younger than 17. As long as there is an age restriction on nonprescription sale of ECPs, every woman who experiences the crisis of a contraceptive emergency either must herself or must have a friend or partner talk to a pharmacist to access ECPs. This required interaction with the pharmacist presents barriers on many levels: women may feel too judged and embarrassed to ask the pharmacist for the medication; pharmacists may arbitrarily refuse to dispense EC; many retail outlets are open longer than the pharmacies they contain; many pharmacies may not routinely stock EC; or men seeking ECPs to care for their partner may be refused, even with proper identification. If it is true that Sebelius' greatest concern was around very young teens using Plan B OneStep, instead of rejecting outright the FDA decision, the Secretary could have approved nonprescription sale for 15and 16-year-olds, based on the data from the actual-use and label-comprehension studies. However, even if she had done so, it is not clear that access would have greatly increased for this group; many 15- and 16-year-olds do not have a government-issued ID (required for proof of age), and therefore they would be turned away by the pharmacist. In his inaugural address in 2009, President Obama vowed to “restore science to its rightful place” [6]. In a speech on March 2009 before signing a presidential memorandum on scientific integrity, Obama stated that promoting science is about listening to what scientists tell us “even when it's inconvenient — especially when it's inconvenient. It is about ensuring that scientific data is never distorted or concealed to serve a political agenda —

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and that we make scientific decisions based on facts, not ideology” [7]. It appears that President Obama and Secretary Sebelius have pushed scientific integrity and concern for women's health aside in the name of electoral politics. We expected far more commitment to evidencebased decision making from this President, based on his promise to change the course of the previous administration. Moreover, Obama and Sebelius lacked the courage to admit that the decision was political by hiding behind a pseudo-scientific emphasis on 11-year-olds; realistically, how many 11- or even 12- to 14-year-olds can get to a pharmacy unsupervised and with US$50? This decision is a continuation of Bush-era policy making in the interest of reelection. The sponsor Teva and the FDA reviewing divisions were negotiating in good faith even on December 7 about the proposed marketing plans. Both were shocked that so much time and money had been spent (especially by Teva Pharmaceuticals for the additional label-comprehension and actual-use studies required, for the FDA submission fee and for creating a responsible direct-toconsumer marketing campaign) when a decision to overrule had already been made. The FDA decision was dead on arrival, a completely unexpected outcome that destroyed a belief in the FDA process by both parties involved. But it is American women who will continue to pay the biggest price. References [1] Sebelius K. A statement by U.S. Department of Health and Human Services Secretary Kathleen Sebelius. December 7 2011. Available at http://www.hhs.gov/news/press/2011pres/12/20111207a.html. [2] Hamburg M. Statement from FDA Commissioner Margaret Hamburg, M.D., on Plan B One-Step, December 7 2011. Available at http://www. fda.gov/NewsEvents/Newsroom/ucm282805.htm. [3] Transcript of the Non Prescription Drugs Advisory Committee in joint session with the Advisory Committee for Reproductive Health Drugs, December 16, 2003. Available at http://www.fda.gov/ohrms/dockets/ac/ 03/transcripts/4015T1.htm. [4] Brune K, Hinz B, Otterness I. Aspirin and acetaminophen: should they be available over the counter? Curr Rheumatol Rep 2009;11:36–40. [5] Carr BC. Efficacy, abuse, and toxicity of over-the-counter cough and cold medicines in the pediatric population. Curr Opin Pediatr 2006;18: 184–8. [6] Obama B. Inaugural address. Available at http://www.whitehouse.gov/ blog/inaugural-address/. [7] Obama B. Remarks of President Barack Obama — as prepared for delivery signing of Stem Cell Executive Order and Scientific Integrity Presidential Memorandum, March 9, 2007. Available at http://www. whitehouse.gov/the_press_office/Remarks-of-the-President-AsPrepared-for-Delivery-Signing-of-Stem-Cell-Executive-Order-andScientific-Integrity-Presidential-Memorandum.