NACDS expresses support of 'chairman's mark' of Senate bill to reauthorize PDUFA

ALEXANDRIA, Va. — The National Association of Chain Drug Stores expressed its support for the legislative package that will serve as a starting point for the reauthorization of the Prescription Drug User Fee Act in a letter to the bipartisan leadership of the Senate Committee on Health, Education, Labor and Pensions.



NACDS wrote to committee chairman Tom Harkin, D-Iowa, and ranking member Mike Enzi, R-Wyo., saying “We applaud your leadership in drafting legislative proposals that will ensure that Americans’ prescription medications and medical devices continue to be safe and effective. Nothing is more important than the health and safety of the patients we serve.”

 

The “chairman’s mark” of the bill will provide the baseline for the committee’s debate and consideration of amendments. The bill includes provisions to further enhance the safety and integrity of the prescription drug manufacturing process, to deter prescription drug counterfeiting, to address drug shortages and to assist the blind and visually impaired in accessing prescription label information.

 

Regarding prescription drug manufacturing provisions, NACDS wrote, “these important enhancements include increased oversight, inspections and audit of both domestic and foreign facilities involved with drug manufacturing, as well as those facilities that prepare active and inactive ingredients used in drug products. Also importantly, [the Food and Drug Administration] will have long-sought authority to destroy any drug refused admission into the U.S. if the drug has a reasonable probability of causing serious adverse health consequences or death. We believe this authority is critical to support FDA’s mission.”

 

The bill’s counterfeiting provisions would increase penalties for the “reprehensible acts” of adulterating a prescription drug or dealing in counterfeit prescription drugs. Provisions related to drug shortages would provide the FDA with advance notice from manufacturers so that the FDA may better respond, prevent and mitigate drug shortages. The bill also would create a working group to develop best practices for assisting the blind and visually impaired with accessing prescription label information.