FDA mulls widely used drugs being available sans prescriptions

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 peoples 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 FDAs mission statement, requiring the agency to encourage medical innovation and job creation.

Were not talking about abandoning standards for safety and efficacy, were 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.

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FDA mulls widely used drugs being available sans prescriptions