HHS chief smacks down FDA's Plan B decision

Look for more hot debate about HHS Secretary Kathleen Sebelius' decision to trump the FDA on expanding access to the Plan B contraceptive. People are talking not only because it's about birth control, but also because this is the first time an HHS chief has publicly contravened an FDA commissioner's decision.

And boy, was it public. Sebelius and FDA chief Margaret Hamburg issued what The New York Times called "extraordinary dueling press statements" about the birth-control product. At issue is whether Teva Pharmaceutical Industries' ($TEVA) product should be taken out from behind the pharmacists' counter, making it available outside pharmacy hours--and without a prescription for girls younger than 17 for the first time.

Hamburg said study data and expert opinion showed young women would benefit from easy access to Plan B, and FDA scientists concluded that it would be safe and effective for adolescent females to use. Sebelius said Teva hadn't studied girls as young as 11 even though 10% of them have reached sexual maturity. Furthermore, there are "significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age."

Pundits of all stripes dispatched their own opinions. Maybe the Obama administration is trying to placate Catholic bishops and other religious groups who didn't like the mandate for insurance coverage on contraceptives, an American Enterprise Institute scholar told the NYT. Politics trumped science, said Kirsten Moore of the Reproductive Health Technologies Project. No, said the Family Research Council: Sebelius was right, because over-the-counter access to Plan B could interfere with doctors' attempts to protect young women from sexual exploitation and abuse.

Nancy Northup of the Center for Reproductive Rights told Bloomberg the Obama administration had now joined its predecessor in "playing politics with women's health." Even some who approved of Sebelius' decision accused Democrats of putting politics first. "It's a presidential election year," Rep. Michael Burgess told the news service.

So, what's next? Some ex-FDA officials told Bloomberg that Hamburg may now feel hamstrung, especially if the White House itself stepped into the Plan B decision. "What crosses the line is if the White House intervenes," ex-Commissioner David Kessler said. Susan Wood, who left the FDA in a dispute over emergency contraception, called on President Obama to order Sebelius to let the FDA do its job. But former Deputy Commissioner Scott Gottlieb said he'd be surprised if Hamburg stepped down, because Sebelius was "within the boundaries of her authority" to overrule her.

- get the FDA statement
- compare the HHS release
- check out Teva's response
- see the NYT story
- get more from Bloomberg
- check out The Wall Street Journal piece

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