FDA Weighs Over-the-counter Switch For Key Drugs


Salon Staff
March 8, 2012 4:36AM (UTC)

WASHINGTON (AP) — Some of the most widely used prescription drugs, including those to treat cholesterol and high blood pressure, could be 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 like 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.

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

Over the years, the FDA has approved the switch of several high-profile prescription drugs for 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, drugmakers could use electronic questionnaires, diagnostic devices like 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 would not need a prescription to receive medication.

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.

Drugmakers would have to request a switch for each drug individually, and the FDA would judge the safety of each proposal on a case-by-case basis.

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


Salon Staff

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