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PDUFA reauthorization bill backed by NACDS
June 20th, 2012
ALEXANDRIA, Va. – As a final congressional vote approaches, the National Association of Chain Drug Stores called on lawmakers to pass the reauthorization legislation for the Prescription Drug User Fee Act (PDUFA)
NACDS said Wednesday that the measure is integral to the review process for new prescription medications and contains key pro-patient, pro-pharmacy provisions.
The Senate and House of Representatives approved their versions of PDUFA last month and worked to reconcile their legislation into one final bill. Both chambers are slated to vote on the final conference report this week, NACDS said.
"Advancing this legislation is important for patient care now and into the future, and NACDS commends Congress for its efficiency in moving it forward," NACDS president and chief executive officer Steve Anderson said in a statement. "As expected, the legislative process also provided for opportunities to consider options on issues ranging from supply chain security to drug abuse and diversion. The final bill includes positive steps forward on these issues. NACDS looks forward to working with legislators, patient advocates and other partners in health care delivery to pursue results-focused solutions in these areas.”
NACDS noted key developments in the legislation that pertain to pharmacy patient care:
• It creates increased requirements, inspections and oversight for domestic and foreign drug and ingredient manufacturing facilities. The Food and Drug Administration would be allowed to destroy counterfeit or adulterated imported drug products and boost the penalties for drug adulteration and counterfeiting of drugs.
• It tasks the Secretary of Health and Human Services with reviewing and reporting on current federal initiatives, gaps and opportunities with respect to ensuring the safe use of prescription drugs with the potential for abuse. The report must include findings and recommendations on how best to leverage and build on federal and federally funded data sources, such as prescription drug monitoring program (PDMP) data and the FDA's Sentinel initiative; develop and disseminate best practice models and suggested standard requirements to states for achieving greater interoperability and effectiveness of prescription drug monitoring programs; produce standardized data on adverse events, patient safety and patient outcomes; and develop provider, pharmacist and patient education tools and a strategy to widely disseminate such tools and assess their efficacy.
• It would require the Government Accountability Office to examine problems posed by drug websites that violate state or federal law. The study would address how such illicit sites operate, the harm to patients and whether additional authorities could assist federal, state, and local governments. It would also examine policies and activities that would educate consumers about how to distinguish legitimate from illegitimate websites.
• It would require FDA to hold a public meeting, within 60 days of the new law's enactment if practicable, on the rescheduling of combination hydrocodone products. The bill does not include an amendment — opposed by patient advocacy groups and health care providers — that would have restricted patient access to hydrocodone products, NACDS said.
"Ensuring a safe and secure prescription drug supply chain is a non-negotiable priority for community pharmacy, as is working to prevent drug abuse and diversion while maintaining patient access to needed medications,” Anderson stated. "These topics merit our continued work and most diligent efforts to come up with truly results-focused solutions, and this PDUFA legislation as it stands is worthy of strong support."