NACDS weighs in on FDA priorities, urging simpler med info for patients

ALEXANDRIA, Va. The National Association of Chain Drug Stores is urging federal health officials to adopt a simpler means of communicating drug safety and efficacy information to patients, and to clear the way for an approval pathway for generic versions of biologically engineered drugs.

 

NACDS made its priorities known in a letter Monday to Margaret Hamburg, commissioner of the Food and Drug Administration. The letter came from Kevin Nicholson, the group’s VP government affairs and public policy.

 

NACDS, he told Hamburg, strongly endorses FDA efforts to adopt a simpler, single medication information document for patients in order to provide clear, easy-to-understand instructions and warnings about possible side effects, etc., of their prescription medicines. Such a document, Nicholson asserted, provides the “final link in the prescription supply chain,” and should be “standardized with respect to format and content.”

Behind that priority: the need to eliminate confusion and improve patient safety, NACDS agreed. “Today, patients receive several different types of written medication information, developed by different sources that may be duplicative, incomplete or difficult to read and understand,” Nicholson pointed out. “This current system is not adequate to ensure that patients receive essential medication information.”

The NACDS official reminded Hamburg that his group was part of a coalition of pharmacy groups that submitted a citizen petition to the FDA in 2008, urging the agency to require drug suppliers to provide “a concise, plain-language document for patients” when they fill a prescription.

Among the group’s other priorities with the agency: adoption of an abbreviated approval pathway for biogenerics. Nicholson also applauded recent efforts by the FDA’s Center for Drug Evaluation and Research and its director, Janet Woodcock, to address lingering skepticism among “certain sectors of the public” about the therapeutic equivalence of generic drugs.

“We applaud Dr. Woodcock for acknowledging this skepticism and for making its resolution a high priority,” he added.

Nicholson also addressed the issue of safety in the pharmaceutical supply chain, noting that NACDS has long supported state efforts to prevent the entry of adulterated or counterfeit drugs into the distribution pipeline. He urged the FDA to continue its stepped-up efforts to assure the integrity of the drug supply system by pursuing “developing global alliances of regulators, more inspections and updated technology systems to assist the agency with increased workload.

“Our industry has supported state-level legislation requiring enhanced wholesale distributor licensure requirements and chain-of-custody ‘pedigrees’ for drug distributions outside the recognized and sale ‘normal distribution channel,'” Nicholson told Hamburg. To that end, he added, “more than 60% of the states have enacted laws and regulations to strengthen the security for the drug distribution supply chain.”

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