CONGRESS URGED TO IMPROVE FDA'S MEDGUIDE CONSUMER INFO PROGRAM

AUGUST 01, 2007

Community pharmacies would be allowed to prepare FDA Medication Guides electronically and send MedGuides to patients via e-mail, under reforms proposed to Congress by chain-drug industry leaders.

The National Association of Chain Drug Stores (NACDS) also urged House Health Subcommittee Chairman Frank Pallone (D, NJ) and Ranking Member Nathan Deal (R, Ga) to develop legislation creating a toll-free number from which pharmacies can obtain "tear-off" pads for all drugs that require MedGuides. The bill sought by NACDS would also establish a new "regulatory pathway for the eventual merger of MedGuide information with the consumer medication information that pharmacies provide voluntarily to patients about their prescription medications." The chain group also wants Congress to direct the FDA to streamline the patient drug-information program by "using a 'class' MedGuide approach when the risks are the same among all similarly acting drugs."



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