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NACDS endorses legislation for PDUFA
April 27th, 2012
ALEXANDRIA, Va. – The National Association of Chain Drug Stores voiced its support for the Senate legislative package that will serve as a starting point for the reauthorization of the Prescription Drug User Fee Act (PDUFA).
NACDS said Thursday that the "chairman's mark" of the bill will provide the baseline for debate and consideration of amendments by the Senate Committee on Health, Education, Labor & Pensions.
"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," NACDS wrote in a letter to committee chairman Sen. Tom Harkin (D., Iowa) and ranking member Sen. Mike Enzi (R., Wyo.).
The legislation includes provisions to bolster the safety and integrity of the prescription drug manufacturing process, thwart prescription drug counterfeiting, address drug shortages, and assist blind and visually impaired pharmacy patients in accessing prescription label information, according to NACDS.
Regarding prescription drug manufacturing provisions, NACDS stated, "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, FDA 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."
Counterfeiting provisions in the bill, NACDS noted, would increase penalties for adulterating prescription drugs or dealing in counterfeit prescription drugs. Provisions related to drug shortages would provide the Food and Drug Administration with advance notice from manufacturers so that the agency can better respond, prevent and mitigate the shortages, the association said.
In addition, the legislation would form a working group to devise best practices for helping the blind and visually impaired with accessing prescription label information.
"Thank you again for your leadership in developing sensible policies for the reauthorization of PDUFA," NACDS concluded in the letter.