FDA official resigns over emergency contraception decision
http://www.100md.com
《英国医生杂志》
The assistant commissioner for women's health at the US Food and Drug Administration, Susan Wood, has resigned after the agency's announcement on 26 August 2005 that it was to postpone a decision on over the counter emergency contraception for teenagers ( BMJ 2005;330: 1466-7, 25 Jun). This was despite the fact that it had promised US senators that it would decide by 1 September, and the drug had been approved by its own panels.
The FDA said that it could not see how emergency contraception could be made available over the counter to women of 17 or older while making it prescription only to younger women. It called for 60 days of public comment and said that it would decide some time later.
In a letter to colleagues, Dr Wood wrote, "I can no longer serve... when scientific and clinical evidence, fully evaluated and recommended for approval by professional staff here, has been overruled." Her decision made the front page of many US newspapers.
The New England Journal of Medicine released a commentary online on 2 September (doi:10.1056/NEJMp058222). "A Sad Day for Science at the FDA" is written by the journal's editor and two experts who had served on the FDA's committees that approved emergency contraception for over the counter use. It said, "This decision—or non-decision—deserves serious scrutiny, since it appears to reflect political meddling in the drug approval process."
The American College of Obstetricians and Gynecologists "reiterated its support for making emergency contraception available without a prescription for all women of reproductive age." It called the FDA's two year delay on approval "a shell game in which women are the losers."
The American Academy of Pediatrics—general physicians who care for children and teenagers—issued a 10 page statement that said, "The American Academy of Pediatrics, as well as other professional organizations, support over-the-counter availability of emergency contraception, tremendous potential to reduce unintended pregnancy rates." The academy joined more than 60 medical and citizens' organisations petitioning the FDA to approve over the counter emergency contraception.(Janice Hopkins Tanne)
The FDA said that it could not see how emergency contraception could be made available over the counter to women of 17 or older while making it prescription only to younger women. It called for 60 days of public comment and said that it would decide some time later.
In a letter to colleagues, Dr Wood wrote, "I can no longer serve... when scientific and clinical evidence, fully evaluated and recommended for approval by professional staff here, has been overruled." Her decision made the front page of many US newspapers.
The New England Journal of Medicine released a commentary online on 2 September (doi:10.1056/NEJMp058222). "A Sad Day for Science at the FDA" is written by the journal's editor and two experts who had served on the FDA's committees that approved emergency contraception for over the counter use. It said, "This decision—or non-decision—deserves serious scrutiny, since it appears to reflect political meddling in the drug approval process."
The American College of Obstetricians and Gynecologists "reiterated its support for making emergency contraception available without a prescription for all women of reproductive age." It called the FDA's two year delay on approval "a shell game in which women are the losers."
The American Academy of Pediatrics—general physicians who care for children and teenagers—issued a 10 page statement that said, "The American Academy of Pediatrics, as well as other professional organizations, support over-the-counter availability of emergency contraception, tremendous potential to reduce unintended pregnancy rates." The academy joined more than 60 medical and citizens' organisations petitioning the FDA to approve over the counter emergency contraception.(Janice Hopkins Tanne)