GAO: No evidence-based need for third class of drugs

(Drug Topics) A recent study by the U.S. Government Accountability Office (GAO) said there is little evidence to support a need for a new class of behind-the-counter drugs that would fall between prescription (Rx) and OTC (over-the-counter) drugs.

This recent GAO study was made in response to a 1995 report regarding the feasibility of a BTC class of drugs. It outlines the concerns that should be addressed before a third class of drugs is created, but says no need for the third class of drugs has been documented.

The GAO also reported on changes in drug availability in five countries since 1995, the impact on availability of restricted nonprescription classes, and arguments supporting and opposing a U.S. BTC drug class.

Although the Food and Drug Administration (FDA) has not developed a detailed proposal for a BTC drug class, it held a public meeting in 2007 to explore the public health implications of BTC drug availability.

The FDA has not indicated which drugs might be classified as BTC. However, among the drugs suggested by some proponents are certain drugs that treat chronic conditions such as high cholesterol, asthma, high blood pressure, diabetes, urinary incontinence, and osteoporosis.

Similar proposals have been considered in the past. In 1995, GAO issued a report titled “Nonprescription Drugs: Value of a Pharmacist-Controlled Class Has Yet to Be Demonstrated.” That report said that there was little evidence to support the establishment of a BTC or similar class of drugs in the United States. The evidence at the time showed that countries with a BTC or similar drug class were not obtaining major benefits from that class.

In its latest study, the GAO examined the classification of 86 selected drugs in five countries — the United States, Australia, Italy, the Netherlands, and the United Kingdom — to review how drugs are classified. According to the report, the impact of restricted nonprescription drug classes on availability is unclear.

The United States required a prescription for more of the 86 drugs under study than did Australia or the United Kingdom, the study countries using a BTC drug class. However, the United States also classified more of the drugs from the sample as OTC than did all four of the other study countries. Additionally, the study did not find an association between the restrictions placed by the study countries on the availability of particular drugs in the sample and the presence of a BTC drug class.

“The United States gave more restrictive classification to some drugs and less restrictive classification to other drugs when compared to the other four study countries,” the GAO said.