In a letter to the chairman and ranking member of the House of Representatives Health Subcommittee of the Committee on Energy and Commerce, the National Association of Chain Drug Stores (NACDS) called for the enactment of provisions that would provide health care cost savings, expand access to medications, facilitate effective communications with consumers, and foster operational efficiency for community pharmacy.

NACDS wrote to Subcommittee Chairman Frank Pallone (D-NJ) and Ranking Member Nathan Deal (R-GA) as the panel began consideration of legislation reauthorizing the Prescription Drug User Fee Act (PDUFA) and components of a broad Food and Drug Administration (FDA) package.

"Pharmacists provide health care services to millions of Americans each day, and are in a unique position to monitor the use of and effects of prescription medications in patients. We offer these suggestions in the spirit of enhancing the safe use of prescription medications by the patients we serve," wrote NACDS President and CEO Steven C. Anderson, IOM, CAE.

NACDS' recommendations included the following:

-- Limit the use of Risk Evaluation and Management Strategies (REMS) to only a limited number of medications, and ensure community pharmacy is part of the design and development of any REMS.

-- Recognize the patient care implications of restricted distribution systems. In addition, ensure that any "managed distribution programs" used for a brand-name drug be made identical for the generic versions of that drug, and ensure that all community pharmacies be provided the opportunity to participate in such managed distribution programs, rather than employing an additional certification requirement.

-- Reform the Medication Guide (MedGuide) program to better serve patients and pharmacies by 1) allowing pharmacies to print MedGuides electronically and e-mail MedGuides to patients; 2) using a "class" MedGuide approach when the risks are the same among all similarly acting drugs; 3) creating a 1-800 number from which pharmacies can obtain "tear off" pads for all drugs that require MedGuides; and, 4) creating a regulatory pathway for the eventual merger of MedGuide information with the consumer medication information (CMI) that pharmacies provide voluntarily to patients about their prescription medications.

-- Exercise caution regarding a proposed toll-free adverse drug reaction (ADR) reporting 800 number, due to the fact that some patients will incorrectly believe the 800 number is a resource for obtaining health advice, when in fact it is solely a reporting mechanism.

-- Close loopholes that delay generic competition, including those relating to reforming marketing exclusivity for pediatric research.

-- Provide a pathway for generic biopharmaceuticals by giving FDA clear authority to use its scientific expertise to review and, where appropriate, approve both comparable and interchangeable biogenerics.

National Association of Chain Drug Stores