"Safe Use Drugs" -- the Saga Continues

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  • 05/08/2012

Per today’s Washington Times, “Health insurers gave a tentative thumbs-up Monday to the Food and Drug Administration’s proposal to make drugs treating chronic conditions available without a prescription by classifying them in an all-new category.”

Insurance companies cautiously support the idea but warned Monday in a letter to the FDA that a host of complications could arise.

Without the right safeguards in place, patients could obtain drugs they don’t need and it’s unclear who would be held liable if they do, said Robert Zirkelbach, spokesman for America’s Health Insurance Plans.

Insurance companies also would have to figure out whether and how they would cover drugs that fall into the new category.

“Expanding access is something that we support, but these other issues would have to be addressed for this to work if they decide to move forward with that,” Mr. Zirkelbach said in an interview.

If the FDA decides to move ahead with the plan, it would create a third category for classifying drugs.

Called “safe use” drugs, patients wouldn’t need a prescription but neither could they obtain them over the counter. Instead, people could only buy the drugs after diagnosing their ailments online or in the pharmacy.

Seeking a way to expand access to drugs for Americans who struggle with common conditions such as high cholesterol, migraines and diabetes, the FDA has raised the idea several times over the past decade and brought it up again in March, asking the public to weigh in.

It’s uncertain whether the agency will sign off on the new policy since the idea has faltered in the past under opposition by doctors and other medical providers. The American Medical Association has said it could open the door to drug misuse and expects that out-of-pocket costs will rise for patients.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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