The Secretary of Health and Human Services took an unusual step on Wednesday to overrule a decision by the Food and Drug Administration to allow Teva Pharmaceutical's (NYSE: TEVA) Plan B pill to be available over-the-counter regardless of the user's age.
According to the New York Times, the reversal appears to have spawned from the debate reverberating straight out of presidential politics, as Health and Human Services Secretary Kathleen Sebelius appears to have acted on an emotional issue touching on parental rights to provide birth control for teenage children.
The maker of the emergency contraceptive, Teva Pharmaceuticals (NASDAQ: TEVA) had applied in February to make the pill available to everyone without a prescription. The company had backed its case with numerous studies (both in-house and third party) that easy access of the drug would help young women. In the FDA decision rendered��and subsequently reversed---the agency's scientists had agreed that the pill was safe and effective in adolescent females, the target market for this application. Secretary Sebelius concluded that the data submitted by Teva ��[does] not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.�� This comes at a direct contradiction with FDA scientists.
Dr. Margaret A. Hamburg, the FDA commissioner, reviewed the studies in question. In written remarks obtained by NY Times, she notes that findings demonstrated that ��adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted disease.�� Further, she continues to say that the data supported findings that adolescent females could safely use the drug without the intervention of a healthcare provider.
The New York Times article discloses that Teva said it was disappointed at the reversal of the positive FDA decision that would have positively impacted the sales of its drug. As the company reviews the reg! ulatory arguments of the reversal, it is likely that Teva will respond to the decision, possibly with data from additional studies and evidence.
However, any reconsideration of this decision by regulators is unlikely to come before the upcoming presidential elections in November 2012. As such, government officials appear to do what they do best: kick the can down the road (or down to their impending successor).
In the mean time, Teva and other pharmaceutical companies are left to fight another day. TEVA closed yesterday at $39.99, down just 0.15 percent on the session. Its primary competitor on the space, Watson Pharmaceuticals Inc. (NYSE: WPI) closed at 61.98 per share, down two thirds of a percent.
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