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US FDA mulls "OTC-plus" drug switches

World News | March 12, 2012


Lynne Taylor

US FDA mulls "OTC-plus" drug switches

The US Food and Drug Administration (FDA) is considering a range of measures to improve access to medicines, including making more drugs used for common, under-treated conditions - such as diabetes, asthma, migraine and high cholesterol - available over-the-counter (OTC).

Under the proposals, pharmacists would be able to supply patients with "OTC-plus" products switched from prescription-only status following a discussion, or in some cases they could fill repeat prescriptions without the need to involve the prescriber after ascertaining that the patient was taking the treatment correctly. Other examples of OTC-plus drugs could include antihypertensives for people whose blood pressure is not acutely high, according to the proposals, which seek to make use of recent developments in computer technology, such as touch-screen self-diagnosis kiosks in pharmacies, to make treatments more easily available for common conditions which are frequently under-treated.

For example, while diabetes is a leading cause of heart disease and stroke, the American Diabetes Association estimates that 7 million out of the 25 million Americans with the condition have not been diagnosed and are not therefore receiving treatment.

Eliminating or reducing the number of routine visits to clinicians in this way “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," adds the agency proposal, which is supported by the industry and also envisages the use by drugmakers of a range of digital tools to help patients take their products correctly.

Applications to switch, and the FDA's decisions, would be on a product-by-product basis.

Commenting on the proposal, FDA Commissioner Margaret Hamburg said that the world is changing and the FDA has to change with it. 

"These are discussions that need to start happening as we think about people's health needs and how to improve access," she added, and emphasised: "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." 

The FDA currently approves switches from prescription-only to OTC status only if the manufacturer can present studies to show that, after reading the patient information, consumers are able to take the product correctly and safely. But this is by no means guaranteed; the Wall Street Journal notes the example of Merck & Co's Mevacor (lovastatin), for which the FDA has repeatedly turned down switch applications because of concerns over whether consumers would be able to accurately evaluate their need for statin therapy.

Speaking to Reuters, Janet Woodcock, director of the FDA Center for Drug Evaluation and Research (CDER), said: "we've had several applications to switch statins to over-the-counter, and they have failed because consumers can't determine their lipid status."

Nevertheless, the OTC-plus initiative could provide a strong incentive for drugmakers to conduct the studies necessary for a switch for blockbuster prescription drugs which are now going off-patent.

Dr Woodcock emphasised that the agency is not  "talking about very specific drugs right now, we're talking about the concept," and added that that she did not expect that the number of products which would switch to OTC-plus status under the proposal to be "vast."

The agency is now seeking feedback from various stakeholders and plans to hold a public meeting on the proposal later this month.


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