Obama Saddles Up For 2012 By Blocking FDA

Dec 7, 2011 by James

In an unprecedented move largely seen as political the Obama Administration’s top health official blocked the FDA from allowing the Plan B contraceptive to become available to teen girls without a prescription. The pill commonly known as the morning after pill is used up to three days after unprotected intercourse to prevent pregnancy. Currently girls under the age of 17 need a prescription for the pill and those over 17 can obtain it over the counter for $50 dollars. The long running debate over the pill is how far the federal government should go to restrict access to the pill.

With the super conservative Republican field of presidential candidates and the front runner being a devout Mormon approval would have meant that Obama would have caught extra flak for his “pro choice” stance. Constantly fearing a fight on anything other than his pet projects Obama decided to have his health chief overrule the FDA and continue to prevent young teens from acquiring the drug even though the FDA says it is safe and effective for them.

FDA Commissioner Margaret Hamburg was ready to approve a request by the drug’s manufacturer, Teva Pharmaceutical Industries Ltd., to remove the current requirement that girls under age 17 need a prescription for the drug. She said the agency found it to be “safe and effective in adolescent females,” and that younger women could properly use the drug without the intervention of a doctor.

Health and Human Services Secretary Kathleen Sebelius seemed to interject her personal feelings (or that of President Obama) into her decision by saying the data didn’t prove it was “appropriate” for young teens to take the pill without a prescription.

“It is commonly understood that there are significant behavioral and cognitive differences between older and adolescent girls and the youngest girls of reproductive age which I believe are relevant to making this determination,” Ms. Sebelius wrote.

Teva Pharmaceutical Industries Ltd. submitted two tests including one that was designed to simulate real world use of the product with 345 girls aged 11 to 17. Amy Niemann, a Teva vice president, said that 90% of the girls were able to use Plan B properly. The other test was to determine if the girls could understand the labeling. Full test results haven’t been made public but in conjunction with the FDA determination that it was safe and the 90% proper usage rate the decision to bar it from minors was purely political. It isn’t for the Health and Human Secretary to decide if it is morally right for girls to have access to the drug.

Ms. Hamburg said the FDA “reviewed the totality of the data and agreed…it should be approved for all females of childbearing potential.”

Plan B would have been made available on shelves if the decision were approved and 17 year olds would still be able to buy it. Women’s health groups have criticized the decision saying the Obama administration has let politics trump science and that there was no rationale for the move. The right leaning groups however praised the decision which I assume is the reaction Obama was after. Frankly I’m not sure what is worse. The idea of a one of the Republican candidates becoming president or the current president being allowed to continue to sell out in order to avoid political ire.