FDA Considering New Over-The-Counter Drugs

The Food and Drug Administration (FDA) is considering making common drugs to treat diseases like diabetes and high cholesterol available to patients over the counter.

The agency is seeking public comment until Friday on a way to make these medications more readily available.

The goal is to make the drugs more available for those patients who have the diseases and do not take medicine.

According to the Centers for Disease Control and Prevention (CDC), high blood pressure cost the U.S. about $76 billion in 2010.

About one in three U.S. adults have high blood pressure, helping to contribute to heart disease and stroke, as well as raising the cost of healthcare in the U.S.

Experts say the unwillingness of people to take certain medications as prescribed is raising the cost of healthcare in the U.S. because those diseases go untreated, leading to other health complications.

The FDA said about a third of those with high blood pressure stop taking their medication.

A typical over-the-counter drug treats short-term conditions with easily recognized symptoms, like a headache or runny nose.

However, taking cholesterol-lowering drugs called statins requires knowledge about a person’s elevated or abnormal levels of fat in the blood.

The FDA rejected Merck & Co’s bid in 2008 to sell its Mevacor statin without a prescription.  It said patients would not be able to decide for themselves whether they were appropriate candidates for the medicine.

However, the agency is now considering ways to allow drugs like Mevacor to be sold over-the-counter.

The FDA said it met with drug makers to discuss ways to help people understand drug risk when they go to a pharmacy, such as using self-serve kiosks, touchscreen pads or interactive videos.

“The world is changing and we have to change to with it,”  FDA Commissioner Dr. Margaret Hamburg told NPR. “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.”

The agency said eliminating or reducing the number of routine visits to the doctor could free up prescribers “to spend time with more seriously ill patients, reduce the burdens on the already over burned health care system and reduce health care costs.”

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.

“We’re not talking about very specific drugs right now, we’re talking about the concept,” Dr. Janet Woodcock, director of FDA’s drug center, told NPR.

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