July 20th, 2006 - Washington, DC – In an effort to ensure affordable generic drugs are brought to the market in a timely manner, Chairman Gordon Smith (R-OR) of the Senate’s Special Committee on Aging joined his colleague, Senator Herb Kohl, the Committee’s Ranking Member, in hosting a hearing titled, “The Generic Drug Maze: Speeding Access to Affordable, Life Saving Drugs.”
“The most significant problem facing our nation’s health care system is the rising costs of care,” said Smith. “Driving much of this growth in costs are prescription drugs. If this trend holds, seniors’ access to important drug therapies will be severely undermined. Generic drug alternatives hold the promise of providing consumers more affordable options. Such savings will only be realized, however, if these drugs get to market in a timely manner.
“There have been a number of troubling reports lately that indicate the generic drug approval process is not working as effectively as it should be. Given the potential cost-savings that could be gained by getting more generic drugs to market, Congress needs to carefully consider whether it is appropriately funding the FDA’s approval activities.”
The hearing examined the challenges and barriers that keep generic drugs from timely approval by the Food and Drug Administration (FDA), as well as anti-competitive practices by pharmaceutical companies to keep generic drugs from entering the market and out of the hands of consumers. The Committee heard testimony from Gary Buehler, Director, FDA Office of Generic Drugs; Jon Leibowitz, Commissioner, Federal Trade Commission (FTC); Heather Bresch, Senior Vice President of Strategic Corporate Development, Mylan Laboratories; and Mark Merritt, President, Pharmaceutical Care Management Association.
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