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Good Question: How Does A Pill Get To Be Sold Over-The-Counter?

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MINNEAPOLIS (WCCO) – Oral contraceptives are some of the most commonly taken prescription drugs in America — at least 10 million American women take them.

But still, half of the country’s pregnancies are unplanned.

Some doctors wonder if seeing a doctor is the problem, and the American College of Obstetricians and Gynecologists is now suggesting that birth control pills be available over the counter, without a prescription.

But what does it take for a drug to go from prescription to over-the-counter?

“It has to be safe enough over a wide range, and it has to work,” said Don Uden, Pharm.D., a professor at University of Minnesota’s College of Pharmacy. Uden served on the FDA advisory committee that looks at whether prescription drugs should go over-the-counter from 2000-2004.

“We approved Prilosec, the purple pill, and Xantac,” Uden said.

The first step is for a birth control manufacturer to ask to go over-the-counter. There’s an application process, requiring evidence of the drug’s safety record.

“The new birth control pills are much safer; I don’t think that’s going to be the issue,” said Uden, noting that regulators may look at the potential side effects of birth control pills in relation to the side effects associated with unwanted pregnancy.

Birth control pills can cause blood clots or potentially deadly thromboembolisms, but other over-the-counter pills also can have damaging side effects.

The FDA committee won’t approve drugs that could be abused. They run studies of a drug’s label – to see if people understand the instructions.

The final question is whether consumers can self-diagnose their concern, which is not really an issue with birth control medication.

Uden said the trend in pharmaceuticals is definitely toward more over-the-counter drugs, giving more control to consumers.

“I think it’s good,” Uden said. “If they can self-diagnose themselves, they can immediately have access to the product.”

There is a question of cost, however. The new health care bill makes insurance companies pay for the total cost of prescription birth control; but insurance doesn’t cover over-the-counter drugs, and wouldn’t cover an over-the-counter birth control pill.

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