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PDUFA reauthorization goals draw support from NACDS


ALEXANDRIA, Va. — A goal to standardize risk evaluation and mitigation strategies and modernize the U.S. drug safety system in a proposed reauthorization of the Prescription Drug User Fee Act has drawn support from the country's main chain retail pharmacy lobby.

The National Association of Chain Drug Stores submitted written testimony Tuesday ahead of a congressional hearing on the reauthorization of PDUFA, originally enacted in 1992.

Specifically, the group endorsed its goals to have the Food and Drug Administration review drug applications for similarity in drug brand names that could result in medication errors and integrate REMS programs into the healthcare delivery system. The testimony also highlighted such policies as medication therapy management and cracking down on illegal sales of drugs on the  Internet.

"We believe that REMS should be subject to review by pharmacies and other relevant healthcare providers, such as by a representative panel of expert reviewers to include pharmacists who practice in pharmacy settings affected by the REMS," the testimony read. "Although pharmacies are not directly responsible to FDA for the design, implementation and success of REMS, pharmacies are subject to the elements of REMS in order to meet the needs of their patients."

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