WASHINGTON — Some of the most widely used prescription drugs, including those to treat cholesterol and high blood pressure, could be available over the counter under a new proposal being weighed by government regulators.
Food and Drug Administration officials said Wednesday they are considering waiving prescription requirements for certain drugs used to treat ailments such as diabetes, asthma and migraines. Driving the move is a wave of computer technology, including touch-screen kiosks found in pharmacies, designed to help patients self-diagnose common diseases.
FDA regulators told reporters that easing access to obtain certain medications could help address undertreated epidemics such as diabetes. Of the more than 25 million Americans with diabetes, an estimated 7 million are not diagnosed and therefore do not receive treatment. Diabetes is a leading cause of heart disease and stroke.
“These are discussions that need to start happening as we think about people’s health needs and how to improve access,” said FDA Commissioner Dr. Margaret Hamburg.
The over-the-counter switch is one of several FDA proposals aimed at increasing access to established drugs or speeding up approval of experimental medications.
After years of high-profile drug-safety cases in which the FDA restricted access to certain medications, the agency is increasingly highlighting its efforts to help drugmakers get new innovative drugs on the market. The shift comes as drug companies and their allies in Congress have pressured the agency to speed up approvals, complaining that U.S. requirements are more burdensome than those in Europe and elsewhere.
Some Republican-backed proposals in Congress would even change FDA’s mission statement, requiring the agency to encourage medical innovation and job creation. Since its creation, the FDA has traditionally evaluated medical products solely on their safety and effectiveness.
