Despite the Food and Drug Agency’s recommendation to allow Plan B, a form of emergency contraception that would prevent pregnancy if used within 72 hours of having unprotected sex, to be sold over the counter to women and girls of all ages, the Obama Administration overruled the agency, refusing to allow it to be obtained by girls under the age of 17 without a prescription.
Now, Senate Democrats are asking Secretary of Health and Human Services Kathleen Sebelius to explain her reasons for overruling the agency and its multiple scientific findings on the drug.
In a letter addressed to the Secretary, and signed by fourteen Democratic senators, including Minnesota Senator Al Franken, the group questions whether it was science or simply politics that made the final decision for the administration.
“We are writing to express our disappointment with your December 7, 2011 decision to block the Food and Drug Administration’s (FDA) recommendation to make Plan B One-Step available over-the-counter. We feel strongly that FDA regulations should be based on science. We write to you today to ask that you provide us with the rationale for this decision.
As numerous medical societies and patient advocates have argued, improved access to birth control, including emergency contraception, has been proven to reduce unintended pregnancies. Nearly half of all pregnancies that occur in the United States each year are unintended. Keeping Plan B behind the counter makes it harder for all women to obtain a safe and effective product they may need to prevent an unintended pregnancy.
We ask that you share with us your specific rationale and the scientific data you relied on for the decision to overrule the FDA recommendation. On behalf of the millions of women we represent, we want to be assured that this and future decisions affecting women’s health will be based on medical and scientific evidence.”
Sebelius has now said that the company can reapply to have the age limit removed once they come back with more testing proving that the contraception will cause no harm to girls between the ages of 11 and 17. “There are always opportunities for the company to come back with additional data. Subsequent discussions can take place.”
However, the drug company has already done testing to the satisfaction of the FDA, according to
Commissioner Margaret Hamburg, M.D. “The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step. Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.”
The fourteen senators who petitioned Sebelius are Franken, Sens. Patty Murray (Wash.), Kirsten Gillibrand (N.Y.), Barbara Boxer (Calif.), Richard Blumenthal (Conn.), Daniel Akaka (Hawaii), Carl Levin (Mich.), John Kerry (Mass.), Tom Harkin (Iowa), Al Franken (Minn.), Frank Lautenberg (N.J.), Ron Wyden (Ore.), Maria Cantwell (Wash.), Jeff Merkley (Ore.). and Sen. Bernie Sanders (I-Vt.).
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