Patient Testimony On PDUFA Benefit

20 April 1997

In testimony about the US Prescription Drug User Fee Act before a SenateLabor and Human Resources Committee, Cynthia Pearson, executive director of the National Women's Network and the Patients' Coalition representative before the Committee, said that this legislation has sped up the drug approval system for all patients without compromising health and safety standards.

While it has become a battleground over issues with the Food and Drug Administration reform, she urged that Congress re-authorize PDUFA without dangerous legislative riders. Ms Pearson also criticized significant provisions in legislation introduced but not passed in the last Congress, and said all patients - but women in particular, need a strong FDA to make sure that drugs are safe and effective.

The Patients' Coalition, a national network of more than 100 patient and consumer advocacy groups, is concerned that elements of the current Congressional FDA reform plan include lowering the safety and effectiveness of new drugs, privatizing many of the FDA's core functions and allowing unrestricted promotion of unapproved drugs.

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