- The Washington Times - Monday, May 7, 2012

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.

The plan, which involves people self-diagnosing their ailments with at most the help of a pharmacist, has pitted players across the health care industry against each other. While doctors complain it would cut them out of the loop and make patients pay out of pocket for more drugs, pharmacists say it would make drugs cheaper and more accessible.

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.

Monday was the last day for the public and such stakeholders as America’s Health Insurance Plans to comment.

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.

But analysts said that even if patients have to pay for more of their drugs initially, it’s likely that the drugs will become cheaper by removing the prescription requirement.

Nancy Chockley, president of the National Institute for Health Care Management, pointed to the allergy drug Claritin. After the FDA authorized it for over-the-counter distribution in 2002, some pharmacists dropped the price by as much as 76 percent.

And with studies indicating that one-fourth of prescriptions are never filled, convenience will be a major factor, Mrs. Chockley said.

“Obviously, it’s much easier for you to go to your drug store and pick up an item than it is to make an appointment, take a prescription, drop it off and get it filled,” she said. “It dramatically increases access and will up sales of these drugs. It’s like going from a boutique drug to mass distribution.”

She said safety is important but downplayed some of the concerns, saying that under preliminary guidance by the FDA, only drugs with a long, reliable track record would likely be eligible for the “safe use” category.

The issue highlights long-standing tensions between doctors and pharmacists, who often find themselves battling for the reins when it comes to patient health.

“I just think it depends on what the FDA’s reading of the tea leaves is,” said Deb Devereaux, vice president of pharmacy for Gorman Health Group. “Pharmacists don’t have any desire to go into a war with physicians or nurse practitioners per se. We’re not trying to diagnose patients.”

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