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Pharmaceutical Industry Labor-Management Association (PILMA) Statement on Prescription Drug User Fee Act (PDUFA)


WASHINGTON, May 17, 2012 /PRNewswire-USNewswire/ -- The Pharmaceutical Industry Labor-Management Association (PILMA) today called on members of the Senate to support the swift and streamlined process for the reauthorization of the Prescription Drug User Fee Act (PDUFA).

By every measure, PDUFA works.

Since its inception, PDUFA has cut the review and approval process for new, life-saving medicines in half - from over 2 years to 1.1 years. This means that innovation within the biopharmaceutical sector has resulted in over 1,500 new medicines designed to fight cancer, diabetes, HIV/AIDS, cardiovascular disease, neurological disorders, and more - enabling these medicines to be manufactured in America, reach the market quicker, and save lives.

From an economic standpoint, PDUFA has enhanced the ability of the domestic biopharmaceutical industry to compete within the global market. In the years before the implementation of PDUFA, U.S. manufacturers suffered a serious competitive disadvantage, due to the fact that 70 percent of new medicines were first marketed overseas and 60 percent of new medicines were on the market overseas for over a year before they were approved in the United States. PDUFA has brought the U.S. process more in line with the rest of the world, while still ensuring the safety and quality of approved medications.

Finally, for the 3.2 million Americans whose employment is supported by the biopharmaceutical sector, PDUFA has helped deliver job security. Every year, America's Building and Construction Trades Unions invest over $800 million in training and certifying their members to meet the high and exacting standards required by the biopharmaceutical industry. By encouraging innovation and capital investment here in the U.S., PDUFA has played an important role in making sure that those union members enjoy continued employment in the construction, renovation and maintenance of domestic biopharmaceutical facilities.

"This year's reauthorization of PDUFA is critical to ensuring the Food and Drug Administration (FDA) remains adequately structured and funded to continue moving biopharmaceutical innovations through the review and approval process," said PILMA Chair and Ironworkers Union General President Walter Wise. "It will foster the development of a pro-innovation environment, a sustained investment in regulatory science, and streamlining initiatives to ensure efficiency and safety. Without these measures, we risk losing the research and technological advancements made by biopharmaceutical companies right here in America that create jobs today and contribute to our nation's future economic growth."

SOURCE  Pharmaceutical Industry Labor-Management Association


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Information in this article was accurate in May 17, 2012. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.