New Rx paradigm? FDA to debate expanding OTC meds

Agency has scheduled hearings for March 22 and 23

Would making more medications available over the counter improve medication adherence? FDA later this month will convene hearings to debate the question and consider a "new paradigm" for selling Rx drugs. 

According to National Journal, research has shown that U.S. residents often fail to take their medications as prescribed and often are dissuaded from doing so by cumbersome prescription and renewal processes. In addition, much of the costs associated with major chronic illnesses in the United States stem from poor condition management, National Journal notes.

Expand the system?
FDA on March 22 and 23 will discuss the merits of a system that broadens access to medications used to treat chronic conditions, including diabetes, migraines, allergies, and high blood pressure and cholesterol.

According to an FDA notice, the "new paradigm" would sell drugs under conditions of safe use, which would vary based on the medication and could require certain products to be available only in predefined health care settings, such as a pharmacy. For example, the system might allow patients to obtain their medication after a quick consult with a pharmacist.

Janet Woodcock, who leads FDA's Center for Drug Evaluation and Research, notes that the flu vaccine provides valuable precedent for a new prescription drug system. Because the vaccine does not require a prescription, millions of U.S. residents obtain it at local pharmacies each year (Fox, National Journal, 2/29 [subscription required]; Fox, National Journal, 2/27 [subscription required]).


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