CMA Comments on FDA’s Behind-the-Counter Drug Proposal
[Posted 12/13/07]

The Food and Drug Administration (FDA) is considering a proposal to create a new class of drugs that could be sold by pharmacists behind-the-counter (BTC). These drugs would be sold without a prescription, and could include birth control, cholesterol, and migraine medicines.

CMA recently submitted comments on this proposal and expressed concern that a BTC classification could have the opposite of its intended effect, and actually reduce patient access to important medications. In recent years, it has become common practice for insurers to drop coverage for nonprescription drugs, particularly those that are moved to over-the-counter (OTC) status. This has increased patients’ out-of-pocket costs, thus reducing their access to these drugs. 

CMA is also concerned that insurance companies might require patients to try BTC drugs as part of a step therapy program before receiving other prescription medications or worse, before seeing a physician. 

“The BTC process will create additional barriers for patients to receive appropriate medical care from physicians,” wrote CMA CEO Joe Dunn in the comments. “It is crucial that patients with multiple chronic conditions receive care from a physician who is capable of managing such complex cases. Pharmacists do not have the appropriate education and training to manage such cases.”

Click here to read CMA's comments.

Contact: Elizabeth McNeil, 415/882-3376 or emcneil@cmanet.org.