NACDS urges Congress to pass PDUFA as final congressional vote nears


ALEXANDRIA, Va. — The National Association of Chain Drug Stores on Wednesday urged Congress to pass the Prescription Drug User Fee Act, legislation essential to the review process for new medications and that also contains important pro-patient, pro-pharmacy provisions.

The U.S. House and Senate passed their versions of PDUFA last month and worked to reconcile their individual bills into one final bill. Both chambers are expected to vote on the final conference report this week.

“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 CEO Steve Anderson said. “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 healthcare delivery to pursue results-focused solutions in these areas.”


NACDS noted important developments in the legislation of particular interest to pharmacy patient care:

  • It creates increased requirements, inspections and oversight for domestic and foreign drug and ingredient manufacturing facilities. It also allows the Food and Drug Administration to destroy counterfeit or adulterated imported drug products and increase the penalties for the knowing and intentional 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 upon existing federal and federally funded data sources, such as prescription drug monitoring program data and the FDA’s Sentinel initiative; develop and disseminate widely 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 online websites that violate state or federal law. The study would address how such illegitimate 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 online 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 healthcare providers alike — that would have restricted patient access to hydrocodone products. NACDS previously expressed its opposition to this provision with other pharmacy groups in a letter to Senate and House leadership during the debate on the legislation. Healthcare provider groups, including the American Medical Association, American Nurses Association and such patient groups as the American Cancer Society Cancer Action Network also expressed opposition to this amendment.

“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 said. “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.”

In related news, the National Community Pharmacists Association also urged the passage of the bipartisan legislation and underscored the importance of the provisions related to community pharmacies, including drug shortages, interoperability of prescription drug monitoring programs and assisting visually impaired and blind consumers. The NCPA pledged to continue to work with Congress on a bipartisan basis to address two issues that were not included in the final legislation: a proposal to enhance pharmaceutical supply chain security (also referred to as "track-and-trace") and greater efforts to reduce the abuse of prescription drugs, such as hydrocodone products.

"This critical legislation addresses several issues of importance to patients and the independent community pharmacists who serve them," said NCPA CEO Douglas Hoey said. "Key provisions in this bill would help address shortages of essential medicine as well as the abuse of prescription drugs, while doing so in a way that does not increase costs or undermine pharmacists’ ability to care for patients. We appreciate the bipartisan work that has gone into the process of developing this legislative package, and the transparency with which the process has been conducted."

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