RX-to-OTC proposal gets mixed reviews

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Industry and physician groups expressed wary support for the FDA's "new paradigm" drug proposal, which would create a nonprescription "Behind the Counter" class of drugs available through pharmacists, but each of the various medical interest groups has its particular reservations

The FDA's proposal says the “new paradigm” class would be limited to drugs that treat chronic conditions, including high cholesterol, migraines, asthma and high blood pressure. The idea, according to the agency, is that easier access to medicines would increase adherence. The proposal says the “need to obtain a prescription for appropriate medication (and to make one or more visits to a practitioner) may contribute to under-treatment of certain common medical conditions.” In some cases, patients would need diagnostic tests.

The Consumer Healthcare Products Association is among those that supports the proposal, but with reservations. The group, which represents drug manufacturers, says fluoride, minoxidil and nicotine replacements are examples of successful Rx-to-OTC conversions. Where CHPA differs with the agency is on the topic of "dual availability." President and CEO President Scott Melville told MM&M dual availability, which means a drug could exist in prescription and OTC versions, is a mistake because it could confuse consumers, and so drugs should be available as one or the other. He also said that a drug's “new paradigm” status should take into consideration a consumer's ability to understand the drug without third-party advice. “If they can't be addressed on the label or through the use of technology they should not be candidates for OTC status,” he said.

The National Association of Chain Drugstores has also backed the FDA's proposal, but with the caveats that the proposal could necessitate a hefty investment in training for pharmacists, and that the pharmacist's desk could become a hide-out area for drugs that don't require clinical advice (like, for example, the sequestration of pseudoephedrine). “This move was based on reducing diversion – there is no clinical need,” NACDS said in a statement. “If a medication is determined to be appropriate for OTC use, it should be available in this manner immediately"

The American Medical Association said in comments to the FDA that it is concerned the proposal has the potential to “undermine the relationship that a patient has with his or her physician" and encourage skipping doctor visits, which might cause changes in the condition treated to go undiagnosed. The AMA says implementing the new tier could work but only if it keeps doctors in the loop and “enhances existing relationships among patients, physicians and pharmacists.”
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