a federal judge and the fda disagree on this
By Jessica Dye and Toni Clarke
NEW YORK (Reuters) - A federal judge criticized the Food and Drug Administration over its refusal to make emergency contraceptionavailable to girls of all ages without a prescription, saying theagency's move to restrict distribution to consumers aged 15 and olderwas not realistic.
District Judge Edward Kormanon April 5 ordered the FDA to lift age restrictions on alllevonorgestrel-based emergency contraception - also known as the"morning-after" pill or "Plan B" - to prevent unwanted pregnancies.
At a hearing in Brooklyn, New York, on Tuesday, he said he wouldrule by the end of the week on the FDA's request to stay the order,which is slated to take effect May 10. The FDA has appealed the rulingto the 2nd U.S. Circuit Court of Appeals in Manhattan.
"I do think there is a principle that is a dangerous one of a court ordering the FDA to approve a drug," FDA Commissioner Margaret Hamburg told the Reuters Health Summit in New Yorkon Monday ahead of the hearing. "You have to step back and look at thisnot just in terms of Plan B but in terms of the precedent."
Late last month, the FDA saidit would allow girls as young as 15 years old to buy Plan B One-Stepcontraception, made by a unit of Teva Pharmaceutical Industries Ltd,without a prescription. Cashiers will still have to verify thecustomer's age before selling it. The agency said the move was based ondata provided by Teva that showed girls of that age could safely usethe drug without the intervention of a healthcare provider.
Korman called the decision "a lot of nonsense," saying that 15- and16-year-olds may not have photo identification needed to buy the drug.
The judge noted that the FDA's restrictions still apply to otherforms of emergency contraception, including a two-pill version of PlanB and its generic equivalents. These are only available to women 17 andolder with identification.
Korman also questioned the timing of the decision, made one daybefore the FDA filed its notice of appeal of the April order.
"I'm convinced the only reason you decided it when it was decidedwas to sugarcoat this appeal," Korman told a lawyer for the FDA, FarzinFranklin Amanat.
A lawyer for the plaintiffs, Janet Crepps of the Center forReproductive Rights, countered that the different access rules for PlanB One-Step and other forms of emergency contraception had created a"convoluted" system for girls and women seeking the drug in its brandname and generic forms.
"That's what happens when you let politicians instead of scientists make these decisions," Korman replied.
Emergency contraceptives generally sell for $10 to $80. Althoughthey can work as long as 120 hours after unprotected sex, they are mosteffective in the first 24 hours.
Asked about the ongoing court case, Teva Chief Executive JeremyLevin said the company provides medicines where they are needed.
"I'm not interested in getting into politics," he told the ReutersHealth Summit. "The bottom line is that we believe we are providing animportant medicine."
(Reporting by Toni Clarke in New York; Editing by Michele Gershberg and Prudence Crowther)
http://news.yahoo.com/judge-criticizes-fda-move-plan-b-agency-warns-112700529.html
By Jessica Dye and Toni Clarke
NEW YORK (Reuters) - A federal judge criticized the Food and Drug Administration over its refusal to make emergency contraceptionavailable to girls of all ages without a prescription, saying theagency's move to restrict distribution to consumers aged 15 and olderwas not realistic.
District Judge Edward Kormanon April 5 ordered the FDA to lift age restrictions on alllevonorgestrel-based emergency contraception - also known as the"morning-after" pill or "Plan B" - to prevent unwanted pregnancies.
At a hearing in Brooklyn, New York, on Tuesday, he said he wouldrule by the end of the week on the FDA's request to stay the order,which is slated to take effect May 10. The FDA has appealed the rulingto the 2nd U.S. Circuit Court of Appeals in Manhattan.
"I do think there is a principle that is a dangerous one of a court ordering the FDA to approve a drug," FDA Commissioner Margaret Hamburg told the Reuters Health Summit in New Yorkon Monday ahead of the hearing. "You have to step back and look at thisnot just in terms of Plan B but in terms of the precedent."
Late last month, the FDA saidit would allow girls as young as 15 years old to buy Plan B One-Stepcontraception, made by a unit of Teva Pharmaceutical Industries Ltd,without a prescription. Cashiers will still have to verify thecustomer's age before selling it. The agency said the move was based ondata provided by Teva that showed girls of that age could safely usethe drug without the intervention of a healthcare provider.
Korman called the decision "a lot of nonsense," saying that 15- and16-year-olds may not have photo identification needed to buy the drug.
The judge noted that the FDA's restrictions still apply to otherforms of emergency contraception, including a two-pill version of PlanB and its generic equivalents. These are only available to women 17 andolder with identification.
Korman also questioned the timing of the decision, made one daybefore the FDA filed its notice of appeal of the April order.
"I'm convinced the only reason you decided it when it was decidedwas to sugarcoat this appeal," Korman told a lawyer for the FDA, FarzinFranklin Amanat.
A lawyer for the plaintiffs, Janet Crepps of the Center forReproductive Rights, countered that the different access rules for PlanB One-Step and other forms of emergency contraception had created a"convoluted" system for girls and women seeking the drug in its brandname and generic forms.
"That's what happens when you let politicians instead of scientists make these decisions," Korman replied.
Emergency contraceptives generally sell for $10 to $80. Althoughthey can work as long as 120 hours after unprotected sex, they are mosteffective in the first 24 hours.
Asked about the ongoing court case, Teva Chief Executive JeremyLevin said the company provides medicines where they are needed.
"I'm not interested in getting into politics," he told the ReutersHealth Summit. "The bottom line is that we believe we are providing animportant medicine."
(Reporting by Toni Clarke in New York; Editing by Michele Gershberg and Prudence Crowther)
http://news.yahoo.com/judge-criticizes-fda-move-plan-b-agency-warns-112700529.html