HHS Overrules FDA on Plan B | The Scientist

After the department of Health and Human Services (HHS) overruled the Food and Drug Administration (FDA) on Wednesday regarding the approval of emergency contraceptive Plan B, many are wondering whether politics, not science, guided the decision. The department ruled to keep existing restrictions on Plan B, which currently cannot be sold without a prescription to those younger than 17, despite the FDA’s conclusion that the drug was safe and effective for fertile women of all ages and should be available over-the-counter.

As a rationale for keeping the restrictions in place, HHS head Kathleen Sebelius said that about 10 percent of women as young as 11 are physically capable of getting pregnant but may lack the cognitive and behavioral development to use Plan B properly.

But many question the scientific merits of the decision. FDA director Margaret Hamburg released a statement in response reiterating that the scientific evidence suggests Plan B is “is safe and effective and should be approved for nonprescription use for all females of child-bearing potential,” ScienceInsider reported. The FDA Office of Women’s Health head Susan Wood previously stated that much riskier drugs, such as acetaminophen (Tylenol), are routinely available over-the-counter. “One of the president’s first executive orders was that we will use science to guide decisions and not politics,” one White House official told The Washington Post.  “And I don’t understand how this can possibly square with science.”

The pill is no stranger to controversy. The FDA was accused during the Bush administration of bowing to conservative politics by resisting all over-the-counter use for the drug.

via the-scientist.com

Posted via email from Jack's posterous