AMA Backs OTC Sales of Morning After Pill, Opposes FDA Decision

National   |   Steven Ertelt   |   Jun 15, 2004   |   9:00AM   |   WASHINGTON, DC

AMA Backs OTC Sales of Morning After Pill, Opposes FDA Decision

by Steven Ertelt Editor
June 15, 2004

Chicago, IL ( — The American Medical Association announced today that it opposes an FDA decision prohibiting over-the-counter sales of the "morning after" pill. The drug is opposed by many in the pro-life community because it sometimes causes abortions and research on its effect on teens has been limited.

The AMA’s House of Delegates approved a resolution on Monday that said the Food and Drug Administration was wrong to have denied an application to sell the so-called morning after pill without a doctor’s visit.

The resolution passed without debate and had strong support during a committee meeting the day before.

Dr. Ronald Davis, who headed the AMA committee that first considered the resolution, told Reuters that an FDA advisory committee felt the drug was safe enough to be sold without a prescription, even though the FDA eventually rejected a request to do that.

Davis said doctors would wrote prescriptions for the drug ahead of time to make it more readily available.

But another doctors group says the FDA made the right decision because the drug shouldn’t be sold to teenagers.

If the drugs are sold without a doctor’s approval, "It is likely that many women, particularly young women, would suffer physical consequences," said Dr. Gene Rudd, associate executive director of the Christian Medical Association.

"These high doses of hormones have not been adequately tested for their effect on teenagers, yet teenagers are a prime market for the drugs," Rudd said.

Rudd believes that the over-the-counter sale of the morning after pill would expose teenagers to an unnecessary health risk. He adds that the drug could also serve to promote risky sexual behavior.

"While many physicians realize that the drug has the potential to terminate the life of a human embryo, many patients do not. Because such views are important to a sizable number of patients, they should be important to every health care provider and drug manufacturer," Rudd said.

After meeting earlier this month with Steven Galson, acting director of FDA’s Center for Drug Evaluation and Research, pro-abortion Rep. Jim Greenwood, a Pennsylvania Republican, says he is "very confident" that the FDA will reverse its decision later this year.

If so, Barr Laboratories, maker of the Plan B drug, will be able to sell the pills without a prescription.

On May 6, the FDA denied Barr’s request, in part because the pharmaceutical company failed to provide enough data about the impact of the drug on teens.

The agency said Barr’s main basis for approval was a study of 585 people who had used the drug. However, the FDA pointed out that only 29 of the subjects were 14-16 years old.

Meanwhile, Rep. Dave Weldon, a Florida Congressman who is a doctor by profession, wrote a letter on behalf of 49 members of Congress asking President Bush to direct the FDA to oppose the sale of the drugs without consultation with a physician.

"We are concerned that adolescent exposure to sexually transmitted infection will increase because of the availability of levonorgestrel over-the-counter," Weldon wrote. "This availability may ultimately result in significant increases in cancer, infertility, and HIV/AIDS."

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