(CHICAGO, September 21, 2007) Congress is in the eleventh hour for debate over the Food and Drug Administration Revitalization Act (FDARA), a funding bill analysts say must pass this week to prevent a budget crisis at the agency.
Experts contacted by The Heartland Institute warn the crunch-time negotiations have produced a flawed measure. The following statements are by experts available to comment on the FDARA and FDA reform generally. You may quote from these statements or contact the experts directly for further comment.
"Is Congress for drug safety or against it? It's hard to tell.
"On the one hand, they say making it easier for trial lawyers to win class-action suits against drug companies will make drugs safer. And some Members of Congress would like to order pharmaceutical companies to continue to monitor their drugs for safety even after they have been approved by the FDA.
"But at the same time, other senators have proposed opening the U.S. to drugs imported from foreign countries, in order to take advantage of their government-imposed drug price controls.
"Currently, pharmaceutical companies are required to protect the supply chain, starting with the manufacturing plant, through distribution channels, and on to pharmacists, physicians, and patients. Negotiators hammering out the Food and Drug Administration Revitalization Act would like to increase that burden.
"But if suppliers can legally introduce other drugs into the supply chain, it will be impossible for pharmaceutical companies to do what they're being asked to do.
"The Food and Drug Administration was created to ensure the safety of America's drug supply. What an irony it would be if Congress were to turn this upside down by giving foreign counterfeiters easy access to our markets--even as it imposes additional safety regulations on drugs that are already FDA-approved."
Devon M. Herrick, Ph.D.
National Center for Policy Analysis
"Increasingly, trial lawyers are determining which drugs can be sold in the U.S. As a result, fewer innovative products are available to patients in need.
"Giving trial lawyers in all 50 states the power to second-guess drug labels through litigation further threatens patient choice and will likely reduce safety."
John R. Graham
Director, Health Care Studies
Pacific Research Institute
"The FDA is in serious need of reform. Out of control lawsuits increase the cost of drugs and deny American patients their choice of medicines."
President and Co-Founder
Center for Medicine in the Public Interest
Former Associate Commissioner of the FDA
"While not a perfect piece of legislation, FDARA finally recognizes that a better funded FDA means that the agency can better fulfill it's mission of both protecting and advancing America's health. The most important part of this legislation, the Reagan/Udall Critical Path Foundation, will allow the FDA to develop the 21st century regulatory science required to provide new therapies to Americans both more swiftly and more safely."
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