The U.S. Food and Drug Administration (FDA) is deciding on a proposal to waive prescription requirements for commonly used drugs that treat conditions like diabetes, asthma, and migraines.
The FDA regulators told reporters that easing access to obtain certain medications could help address undertreated epidemics, namely diabetes. According to the American Diabetes Association, of the nearly 26 million Americans with diabetes, an estimated 7 million don't even realize it and thus have not gotten diagnosed or treated. Diabetes is a leading cause of heart disease and stroke.
“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. 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.
This shift from the earlier strict regulations on availability and innovation comes as drug companies and their congressional allies have pressured the agency to speed up approvals, complaining that U.S. requirements are more difficult than elsewhere in the world. “The world is changing and we have to change to with it,” Hamburg said. “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.”
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.
On cholesterol lowering statins, “We've had several applications already to switch statins to over the counter, and they have failed because consumers can't determine their lipid status,” Janet Woodcock, head of the FDA's drugs center, told Reuters.
The new industry-backed proposal is driven in part by a wave of computer technology, including touch-screen kiosks found in pharmacies, designed to help patients self-diagnose common diseases. Drugm akers 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 get medication.
Experts say the unwillingness of people to take certain medications as prescribed has undermined effective treatment of conditions including high blood pressure, raising the cost of healthcare in the United States. About one in three U.S. adults has high blood pressure, which contributes to heart disease and stroke. The condition cost the United States about $76 billion in 2010, according to the Centers for Disease Control and Prevention. The FDA said about a third of those with high blood pressure stop taking their medication.
The agency also says decreasing doctor visits could be beneficial. “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 and 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.
The FDA will discuss its proposal at the public meeting before developing further guidance. Drug makers would then have to apply for each drug to be in a new category.
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