This isn't exactly surprising, but it pissed me off nonetheless.
http://www.cnn.com/2004/HEALTH/05/06....ap/index.html
FDA rejects over-the-counter morning-after pill
Thursday, May 6, 2004 Posted: 9:55 PM EDT (0155 GMT)
WASHINGTON (AP) -- The government rejected over-the-counter sales of morning-after birth control Thursday, citing concern about young teenagers' use of the pills. But regulators left open the possibility they will reconsider.
Proponents immediately accused the Food and Drug Administration of bowing to conservative political pressure -- noting that the agency had overruled its own scientific advisers, who had overwhelmingly called easier access to emergency contraception a safe way to prevent thousands of abortions.
In a letter to Barr Laboratories late Thursday, the FDA said there wasn't evidence that teens younger than 16 could safely use the pills without a doctor's guidance.
Warned of FDA's teen concern in February, Barr had proposed allowing nonprescription sales for everyone 16 and older, but requiring a prescription for anyone younger.
Such a step, which presumably would require drugstores to check customers' ages, has never been tried. The FDA said the company didn't provide many details, making it impossible to decide if such a program would be legal and doable.
But Thursday, FDA officials left open the door for Barr to try again, telling the company what information they would need to reconsider: either data showing young teens could use the pills safely without a prescription, or details on how to make the mixed-marketing approach work.
"Wide availability of safe and effective contraceptives is important to public health," the FDA letter said. "We look forward to continuing to work with you if you decide to pursue either of these options."
Barr chief executive Bruce Downey said in an interview that the company would rapidly pursue one or both options -- even as it more actively advertises its prescription morning-after brand, called Plan B, so more women know that taking the pills within 72 hours of intercourse can greatly reduce their risk of pregnancy.
"It's a matter of weeks and months to deal with this objection," Downey said, saying that means FDA could reconsider the issue within a year. "Clearly ... the door's open, and we plan to go through it."
Contraceptive advocates decried the decision, saying easier access to emergency contraception could have cut in half the nation's 3 million unintended pregnancies each year -- by lifting barriers to women getting them in time after rape, contraceptive failure or just not using regular birth control.
"The decision blatantly disregards the overwhelming scientific evidence," said Kirsten Moore of the Reproductive Health Technologies Project. "The Bush administration has denied American women timely access to a safe, proven second chance to prevent pregnancy."
Bush's Democratic rival, Sen. John Kerry, criticized the decision through spokesman. "The White House is putting its own political interests ahead of sound medical policies that have broad support," said campaign spokesman Phil Singer.
The FDA's move will "have a negative impact on the public health," said Dr. Alastair Wood of Vanderbilt University, one of the FDA advisers who voted 23-4 in December to back the nonprescription switch.
Noting that emergency contraception is sold without a prescription in numerous other countries, he added: "It seems a tragedy to me that American women don't have the same access to effective drugs that English and Canadian women do."
Studies on college campuses show a decline in pregnancy and abortion with wider availability of the morning-after pill, and there's no reason to think young teens -- who are less likely to use regular contraception -- would be any different, said University of Wisconsin pediatrician Dr. Scott Spear, a Planned Parenthood spokesman.
But conservatives who had intensely lobbied FDA that nonprescription emergency contraception would encourage teen sex lauded the decision.
"The FDA is siding with our nation's teens and their health," said Rep. Dave Weldon, R-Fla, who is a doctor.
"The FDA is right to be cautious about having a potent drug that can harm women next to candy bars and toothpaste," added Wendy Wright of Concerned Women for America, an anti-abortion group.
Within the FDA, the decision was mixed. An internal agency memo, obtained by The Associated Press, suggests medical reviewers backed nonprescription sales but were overruled by senior officials.
"Some staff have expressed the concern that this decision is based on non-medical implications of teen sexual behavior, or judgments about the propriety of this activity," said the memo, written by FDA acting drug chief Dr. Steven Galson. "These issues are beyond the scope of our drug approval process, and I have not considered them in this decision."
Galson noted that some 11- to 14-year-olds are sexually active but that "despite the urgent need to prevent pregnancy in these young adolescents, the application contained no data in subjects under 14 years of age."
The morning-after pill is simply a higher dose of regular hormonal contraception. Taken within 72 hours of intercourse, the pills cut the chances of getting pregnant by up to 89 percent.
The sooner they're taken, the more effective they are. But it can be hard to find a doctor to write a prescription in time, especially on weekends and holidays.
If a woman already is pregnant, morning-after pills have no effect.
To improve access, California, Washington, Alaska, Hawaii and New Mexico already allow women to buy morning-after pills from certain pharmacists without a prescription. The FDA's decision does not affect those programs.
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Here's the worst part:
Quote:
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"The FDA is right to be cautious about having a potent drug that can harm women next to candy bars and toothpaste," added Wendy Wright of Concerned Women for America, an anti-abortion group.
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FUCK YOU, LADY. LIKE YOU ACTUALLY GIVE A SHIT ABOUT WOMEN'S HEALTH.
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