Health and Human Services Secretary Kathleen Sebelius on Wednesday used her power to trump the Food and Drug Administration's plan to do away with the age limit on who can buy Teva Pharmaceutical Industries Ltd' s Plan B One-Step pill without a prescription.
The pill, which has to be taken within 72 hours of unprotected sexual intercourse, has been available without a prescription to women over 17, but they have to still ask a pharmacist for help and show identification for an age check.
Girls under 17 need a prescription to buy the drug.
Sebelius's move drew shocks and puzzlement from women's health advocates who say it goes against President Barack Obama's pledge to reassert the power of science in his administration's decisions.
An FDA spokeswoman said no health secretary has ever overruled the agency. The FDA itself has drawn fire in the past for being slow to expand access to the morning-after pill.
FDA approval would have likely put the morning-after contraceptive on drugstore shelves next to condoms and other family-planning products -- a politically sensitive issue leading up to the 2012 elections.
"The whole thing is extraordinary and does not make any sense," said Susan Wood, former head of the FDA's Office of Women's Health who resigned in protest over the agency's handling of the drug in 2005.
"I had come to believe that the FDA would be allowed to make decisions based on science and the public's health. Sadly, once again, FDA has been overruled and not allowed to do its job."
The White House had no immediate comment on Sebelius's decision. It was unclear how electoral politics might have figured in the move.
"The Secretary made this decision," an administration official said when asked whether it was made by Sebelius alone.
When asked whether she consulted in advance with President Barack Obama or with the White House, the official would only add: "Agencies routinely consult/inform the White House about a wide range of issues and decisions."
Teva had asked the FDA to lift the age limit to allow all women capable of getting pregnant quick access to the drug. The company had given the FDA new data from a study of actual use of the contraceptive in girls ages 11 to 16.
Teva has maintained that wider access was not intended to sell Plan B to teenage girls, but to allow the company's target audience of women aged 18 to 49 to be able to buy the pill without an uncomfortable ID check, and at any time.
FDA experts' review supported approval of Teva's request and Commissioner Margaret Hamburg planned to do just that, but Sebelius's disagreement led her to leave access to Plan B One-Step limited.
Sebelius said Teva did not present enough evidence to show that younger girls would properly understand and use the pill, meant to prevent unintended pregnancies, without talking to a doctor first.
"After careful consideration of the FDA Summary Review, I have concluded that the data, submitted by Teva, do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age," she said in a statement."
It remains unclear what specific data she believes is lacking.
Sebelius highlighted that while on average girls reach reproductive age by 12.4 years, some are capable of bearing children at 11.1 years.
Teva expressed its disappointment at the last-minute HHS action despite FDA's positive recommendation. Spokeswoman Denise Bradley said Teva has not yet received FDA's rejection letter. The company's shares closed down 0.2 percent on the Nasdaq.
LONG-TIME BATTLE
The move is the latest salvo in a decade-long battle over the pill, which critics say could lead to promiscuity, sexual abuse and fewer important doctor visits if readily available for purchase.
Advocates for such emergency pills say they help reduce unwanted pregnancies or abortions and that quick, easy access for women of all ages is critical for the medicines to work.
Medical and women's groups since 2001 have sought wider access for the drug, which Teva acquired in 2008, and have in the past sued the FDA over Plan B . Many now say they plan to boost their efforts to hold Sebelius and Obama accountable.
Their efforts had previously stalled under President George W. Bush, unleashing a wave of lawsuits and congressional protests that the FDA was letting politics trump science.
In 2006, the FDA allowed limited "behind the counter" sales for women 18 and older that required identification checks. In 2009, the agency lowered the limit to age 17 while continuing to require prescriptions for younger girls.
Plan B, approved for sale in 1999, contains a higher dose of the hormone progestin that has been widely used in regular birth control pills for decades. It was sold in a two-pill version until 2009.
FDA experts, including gynecologists and pediatricians "reviewed the totality of the data (on Plan B) and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential," Hamburg said in a statement.
(Editing by Robert MacMillan, Bernard Orr)
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