Politics Vs. Science in the Plan B Decision Was Sebelius Politically or Scientifically Correct to Block Broader Plan B Availability?

December 7, 2011: A Date Which Will Live in Infamy for Women’s Health!

“If I close my eyes…I might think I was in the Bush era,” said Michelle Goldberg (@michelleinbklyn), Senior writer for Newsweek/The Daily Beast, and author of Kingdom Coming and The Means of Reproduction. Her remark — made via Twitter, of course — was in reference to “Obama’s terrible decision to override the FDA on Plan B.”

By now you’ve all probably heard the news as reported in the NY Times: “For the first time ever, the Health and Human Services secretary publicly overruled the Food and Drug Administration, refusing Wednesday to allow emergency contraceptives to be sold over the counter, including to young teenagers. The decision avoided what could have been a bruising political battle over parental control and contraception during a presidential election season.”

The action was taken by U.S. Department of Health and Human Services Secretary Kathleen Sebelius in a letter addressed to FDA Commissioner Margaret Hamburg, M.D. Find that letter plus statements by both Sebelius and Hamburg here, where you can also vote on who you think is right.

Sebelius blocked the FDA from allowing the contraceptive pill, called Plan B One-Step, to be made available without a prescription (over-the-counter) to women and girls 16 and younger who now need a prescription to get Plan B. “If taken soon after unprotected sex, the pill halves the chances of a pregnancy,” according to the NY Times (op cit).

Sebelius said in a statement to the FDA (find it here): “The science has confirmed the drug to be safe and effective with appropriate use. However, the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. I do not believe that Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use.”

Hamburg said in a response (find it here): “I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center 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.”

Who’s right? Hambug or Sebelius? Vote here.

Before you vote, however, you should read “Science, Politics, and Over-the-Counter Emergency Contraception” by Robert Steinbrook, MD. It was a viewpoint published in JAMA online (see here).

Steinbrook noted: “The comprehension study [submitted to FDA by Teva Women’s Health, Plan B supplier] included 335 participants who were recruited at malls and clinics, with 54 to 59 participants of each year of age, between the ages of 12 and 17.9 The study evaluated 6 key concepts related to understanding of a prototype label for Plan B One-Step, such as, that the drug was indicated for prevention of pregnancy after unprotected sex, should be taken as soon as possible after sex, does not prevent sexually transmitted diseases or HIV/AIDS, and should not be used in place of regular contraception. Each of the 6 concepts were understood by between 79% and 93% of those aged 12 through 14 years and between 86% and 98% of those aged 15 through 17 years, leading to the conclusion that teenagers could understand the label ‘well enough to enable safe and effective use without assistance from a clinician.'”

Sebelius focused on the fact that the study “did not contain data for all ages for which this product would be available for use.” According to Tina Raine-Bennett, MD, MPH, of the Women’s Health Research Institute at Kaiser Permanente Northern California, a principal investigator of the University of California-San Francisco study, “It is unreasonable and virtually impossible to study the use of emergency contraception in 11- and 12-year-olds, because only a small fraction of them will have had sex by that age.” Parts of this story was originally published in Pharma Marketing Blog on December 7, 2011.

Issue: Vol. 10, No. 19
Publication date: 21 December 2011

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