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FDA mulls widely used drugs being available sans prescriptions

- Associated Press - Wednesday, March 7, 2012

Some of the most widely used prescription drugs, including those to treat cholesterol and high blood pressure, could be freely available over the counter under a new proposal being weighed by government regulators.

Food and Drug Administration officials said Wednesday they are considering waiving prescription requirements for certain drugs used to treat ailments such as diabetes, asthma and migraine.

Driving the move is a wave of computer technology, including touch-screen kiosks found in pharmacies, designed to help patients self-diagnose common diseases.

FDA regulators told reporters that easing access to obtain certain medications could help address undertreated epidemics like diabetes, a leading cause of heart disease and stroke. Of the more than 25 million Americans with diabetes, an estimated 7 million are not diagnosed and therefore are not treated.

"These are discussions that need to start happening as we think about people's health needs and how to improve access," said FDA Commissioner Dr. Margaret Hamburg said.

The over-the-counter switch is one of several FDA proposals aimed at increasing access to established drugs or speeding up approval of experimental medications.

After years of high-profile drug safety cases in which the FDA restricted access to certain medications, the agency is increasingly highlighting its efforts help makers get new, innovative drugs on the market. Some Republican-backed proposals in Congress would even change FDA's mission statement, requiring the agency to encourage medical innovation and job creation.

"We're not talking about abandoning standards for safety and efficacy, we're talking about leveraging opportunities in science so we can do a more-effective job as regulators and also improve the drug development process," Dr. Hamburg said.

Over the years, the FDA has approved the switch of several high-profile prescription drugs to over-the-counter use. In 2003, the FDA cleared Prilosec, an over-the-counter version of the blockbuster AstraZeneca heartburn drug Nexium.

The FDA only approves such changes if studies show that patients can safely take the drug after reading the package labeling. Under the industry-backed proposal, drug-makers could use electronic questionnaires, diagnostic devices such as blood pressure monitors and other computer-assisted technology to guide patients.

In some cases, patients would still need to see a doctor to obtain an initial prescription before getting over-the-counter refills. In other cases, patients would need to speak with a pharmacist but not need a prescription.

The agency also predicts a number of benefits from decreasing doctor visits.

"Eliminating or reducing the number of routine visits could free up prescribers to spend time with more seriously ill patients, reduce the burdens on the already overburdened health care system and reduce health care costs," the agency states in recent federal notice about the proposal.

FDA officials stress that the idea is still in the early stages. A public meeting is scheduled for later this month to gather comments.

"We're not talking about very specific drugs right now, we're talking about the concept," said Dr. Janet Woodcock, director of FDA's drug center.

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