NCPA Commends House Passage of PDUFA Reauthorization

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Alexandria, Va. - June 20, 2012 The National Community Pharmacists Association (NCPA) today voiced support for approval by the U.S. House of Representatives of the FDA Safety and Innovation Act of 2012 (also known as the Prescription Drug User Fee Act). The bipartisan legislation is expected to be approved by the Senate shortly before going to President Obama to be signed into law.

"This critical legislation addresses several issues of importance to patients and the independent community pharmacists who serve them," said NCPA CEO B. Douglas Hoey, RPh, MBA. "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."

The provisions relating to community pharmacies include:

  • Drug Shortages: The bill requires the Drug Enforcement Administration (DEA) to provide timely approvals or denials of manufacturer requests for increases of quotas of Schedule II controlled substances in circumstances in which such an increase could help address a drug shortage situation. The bill also requires the GAO to conduct a study to examine the causes of drug shortages and issue recommendations on how to prevent or alleviate drug shortages.
  • Interoperability of Prescription Drug Monitoring Programs: The bill would allow the Secretary of HHS to facilitate the exchange of prescription drug monitoring program information across state lines to prevent abuse and would require a report on such facilitation. It also requires HHS to create a report on current federal initiatives to ensuring safe use of prescription drugs, to identify both gaps and opportunities for further advancement of this issue. In addition, the legislation calls for a thorough study of the problem of rogue, online pharmacy websites.
  • Assisting Visually Impaired and Blind Consumers: The bill requires the development of best practices on the issue of accessibility of information in prescription drug labeling for visually impaired and blind consumers. It also requires the GAO to study the utilization of such best practices.

NCPA also 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 (sometimes referred to as "track-and-trace") and greater efforts to reduce the abuse of prescription drugs, such as hydrocodone products.

"While the nation's pharmaceutical supply is safe, NCPA also supports measures to further enhance its safety," Hoey added. "For many months, we have been actively involved with a broad coalition of pharmaceutical supply chain stakeholders, known collectively as the Pharmaceutical Distribution Security Alliance (PDSA). Through PDSA, NCPA has worked constructively with lawmakers toward practical approaches, such as the RxTEC framework, to further strengthen the U.S. pharmaceutical supply chain without raising health care costs or imposing undue burdens on small business community pharmacies.

"Similarly, the right balance must be attained in combating the scourge of prescription drug abuse. Community pharmacists are on the front lines helping patients use their medication properly and guarding against drug diversion and abuse. At the same time, we must be mindful of patients who have a legitimate need for these products and health care costs that could rise under the wrong approach. Going forward, NCPA will keep working across party lines in both of these critical areas."

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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