NCPA Offers Senators Recommendations on PDUFA Reauthorization

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Alexandria, Va. - April 24, 2012

As a U.S. Senate committee prepares legislation reauthorizing the Prescription Drug User Fee Act (PDUFA), the National Community Pharmacists Association (NCPA) today submitted recommendations to address the views of local pharmacists.

In a letter to the Senate Health, Labor, Education and Pensions Committee Chairman Tom Harkin (D-Iowa) and Ranking Member Mike Enzi (R-Wyo.), NCPA responded to a "manager's amendment" announced Monday that would revise the legislation. NCPA's comments focused principally on prescription drug shortages and supply chain integrity.

"We believe the current pharmaceutical supply chain in the United States is safe and secure," said NCPA CEO B. Douglas Hoey, RPh, MBA. "As we strive to further strengthen security, there are a number of different approaches or tactics that could be employed.

"In addition, while most reported drug shortages to date have occurred in hospital settings, community pharmacies are also experiencing shortages, primarily in drugs that treat ADHD," Hoey added. "The effects of these shortages could be mitigated by reforming the Drug Enforcement Agency's (DEA) quota system and by ensuring that pharmacy reimbursement rates are updated more frequently to reflect price spikes and keep pharmacies whole. In these and other areas, we look forward to continuing to work constructively with Congress as a PDUFA reauthorization is enacted into law this year."

NCPA's letter includes the following points:

  • In the community pharmacy setting, shortages of drugs that treat ADHD appear due, in part, because of the inflexibility of the current DEA quota system, which limits the quantity of certain medications that manufacturers can make in any given year. Congress should include in any final bill provisions requiring DEA to act more favorably and expeditiously on manufacturer requests to increase quotas for certain controlled substances that are in short supply. Moreover, third party payers—including Medicare Part D and Medicaid—have not responded quickly enough to increase their reimbursement as costs go up. Lagging reimbursement rates unfairly force pharmacies to absorb the increased costs of these medications.
  • NCPA supports language included in the amendment that would create voluntary "best practices" for pharmacists regarding the provision of enhanced prescription information to visually impaired and blind individuals.
  • While the manager's amendment does not include so-called track-and-trace proposals regarding supply chain integrity, NCPA offered cost-effective recommendations in this area should lawmakers revisit the issue. First, NCPA supports the RxTEC proposal, developed by a diverse group of provider and pharmaceutical stakeholders, which would create a lot-level tracking program for prescription drugs and also require that each prescription drug container include a unique serial number. Second, in considering RxTEC or other supply-chain proposals, Congress should avoid placing new burdensome requirements on small business community pharmacies such as requiring pharmacies to individually "scan" each product as it enters its pharmacy. Third, NCPA supports establishing federal standards for wholesaler licensure.

The National Community Pharmacists Association (NCPA®) represents the interests of America's community pharmacists, including the owners of more than 23,000 independent community pharmacies. Together they represent a $93 billion health care marketplace, dispense nearly 40% of all retail prescriptions, and employ more than 315,000 people, including 62,400 pharmacists. Independent community pharmacists are readily accessible medication experts who can help lower health care spending. They are committed to maximizing the appropriate use of lower-cost generic drugs and reducing the estimated $290 billion that is wasted annually by improper medication use. To learn more go to or read NCPA's blog, The Dose, at

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