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FDA to reconsider morning-after pill

November 16, 2005

The morning-after pill might be available over the counter after congressional investigators questioned the Food and Drug Administration's requirement to consider it a prescription.

The independent Government Accountability Office reviewed the FDA's first rejection, uncovering what they called "unusual" decision making.

Among findings in the audit released on Monday was evidence that the decision was made months before scientific reviews were completed, and there was unusual involvement from high-ranking agency officials.

"It is all about politics and ideology trumping science," said Sarah Scranton, executive director of the Planned Parenthood Affiliates of Michigan. "All of the scientific facts show that emergency contraception is very effective and safe."

The morning-after pill is a high dose of regular birth control that can lower the risk of pregnancy by up to 89 percent. The sooner it's taken, the more effective it is, but it can be difficult for women to get a prescription in time.

When the pill was first examined in 2003, the FDA's scientific advisers overwhelmingly backed making it over-the-counter for all ages, but FDA leaders rejected it the following May citing concern about young teens' use of the pills.

The maker reapplied, seeking to sell Plan B without a prescription to women 16 or older while younger teens would continue to need a doctor's note. In August, FDA's then-commissioner postponed that decision indefinitely.

There are no studies that show the long-term effects using Plan B has on a woman's body, said Paul Long, the vice president for public policy for the Michigan Catholic Conference. "The FDA has approved other pharmaceuticals that everyone believes to be safe, yet the end result is that people are dying and there are lawsuits against pharmaceutical companies."

Making a drug like the morning-after pill more accessible to women could lead to more casual sex or sex outside of marriage, which can be devastating, Long said.

"It's not about ideology, it is about due respect for women," he said.

Information stressing that it's only to be used as an emergency contraceptive would be crucial, but easier availability could be beneficial to many, said Dennis Martell, an Olin Health Center health educator and SN columnist.

"Some people don't have the option to go in and get an appointment to get a prescription," Martell said. "In those places, this may be the best and only option."

The Associated Press contributed to this report.

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