US official nixes pills to young teens
Source: Agencies |
December 9, 2011, Friday
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THE United States health secretary overruled government scientists and refused to bring the controversial morning-after pill from behind the pharmacy counter and onto drugstore shelves.
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 shock 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, the FDA has been overruled and not allowed to do its job."
The White House had no comment on Sebelius's decision.
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 aged 11 to 16.
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."
The move is the latest salvo in a decade-long battle over the pill, which critics say could lead to promiscuity and sexual abuse.
Advocates for such emergency pills say they help reduce unwanted pregnancies or abortions.
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 shock 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, the FDA has been overruled and not allowed to do its job."
The White House had no comment on Sebelius's decision.
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 aged 11 to 16.
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."
The move is the latest salvo in a decade-long battle over the pill, which critics say could lead to promiscuity and sexual abuse.
Advocates for such emergency pills say they help reduce unwanted pregnancies or abortions.
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