FDA Mulls Over-the-Counter Measures

The FDA is considering a major change that could bring down health care costs for some patients who take prescription drugs for chronic conditions.

The idea: make the drugs available over the counter, without prescription, reports CBS News Medical Correspondent Elizabeth Kaledin.

Over-the-counter drugs have long been a gold mine for treating minor, short-term ailments: headaches, stomach aches and colds. But this week the Food and Drug Administration opened public hearings on whether some prescription drugs should be switched to over the counter status to treat major chronic illnesses: high cholesterol, high blood pressure, arthritis and allergies. Even birth control pills are being considered.

"Safety has to be the number one priority here, because we really up the ante of risk when these products are out there on the market," says the FDA's Janet Woodcock.

Many in the pharmaceutical industry oppose changes in the FDA's system, saying it already protects consumers well. But the idea is to improve overall public health by making well tested drugs available to more people who either don't want to see a doctor or can't afford to.

For Steve Francesco, a drug industry consultant, it's an idea whose time has come. "There's a lot of drugs that could be made available to the American public," he says. "But it has to be done carefully and scientifically. If you can do it, you can alleviate a lot of suffering."

Makers of the popular cholesterol lowering drugs Mevacor and Pravachol have already applied for over the counter status. But Doctors are skeptical, and some fear an anarchy of self-medication.

"The worst case scenario would be that these drugs are released for widespread use and patients were harmed because of inappropriate or unmonitored use," says Dr. David Vorchheimer of the Mt. Sinai School of Medicine.

And for the elderly and poor, more over the counter availability could mean less insurance reimbursement. With so many interests at stake, the FDA has set the stage for a lengthy debate and faces a difficult balancing act in making any changes.