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Patient Organizations Campaign Urges Swift and Clean Reauthorization of the Prescription Drug User Fee Act (PDUFA)

April 11, 1997

A note from The field of medicine is constantly evolving. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

Contacts: Lisa Cox, (202) 347-1140
or Gary Rose, (202) 986-1300 x3026

The Patients' Coalition:
An Independent Coalition of Patients With Serious And Life-Threatening Diseases
Working Together For Responsible FDA Reform

In testimony before the Senate Labor and Human Resources Committee today, The Patients' Coalition, a national network of more than 100 leading patient and consumer advocacy groups, continued its campaign to prevent the enactment of irresponsible legislation which would put at risk American patients' ability to fast access to drugs and medical devices which are proven to be safe and effective. Cynthia Pearson, Executive Director of the National Women's Health Network, representing the Patients' Coalition, criticized significant provisions of Congressional proposals now in development. Those proposals are to be based on controversial provisions in legislation introduced but not passed in the 104th Congress. "All patients, and women in particular, need a strong FDA to ensure that drugs are both safe and effective. We reject any legislation that undermines FDA's public health mandate."

At the center of the current debate is the need to reauthorize PDUFA. Widely supported by industry, government, and consumers, PDUFA charges pharmaceutical manufacturers users fees to improve FDA's capacity to process new drug applications. "PDUFA has been a great success. It has sped up the drug approval system for all patients, but without compromising essential health and safety standards," Ms. Pearson said. "Unfortunately, though, PDUFA has now become a battleground over issues of so-called FDA reform which seek only to speed the ability to market drugs while doing grave injury to the FDA's ability to protect the public health. The Congress should pass PDUFA immediately without dangerous legislative riders. PDUFA is too important to all Americans to be threatened by legislative gridlock."

Congress is developing FDA proposals that would weaken 90 years of public health regulation of pharmaceuticals. Elements of the Congressional plan include lowering safety and effectiveness of new drugs, privatizing many of FDA's core functions, and allowing unrestricted promotion of unapproved drugs. The Patients' Coalition is concerned that PDUFA will become a hostage to anti-patient proposals that might not pass if they were considered independently.

"Patients with serious diseases need and are getting fast FDA drug approvals. Further speeding approvals will offer no real benefits to patients if the cost is exposure to dangerous drugs and devices. This violates the basic principles of public health and must not be permitted" Ms. Pearson said. "True reform of the FDA requires the preservation of public health protections while improving the agency's resources so they can operate more efficiently. PDUFA has been a success on both counts. We will continue to give voice to the concerns of consumers in this important debate."

The Patients' Coalition formed in the summer of 1995 to bring the concerns of Americans with serious and life-threatening illnesses to the forefront of FDA reform debates. The Patients' Coalition has testified before both House and Senate committees on FDA reform in the 104th Congress, worked with the national media, and mobilized grass roots support for responsible drug regulation.

For further information, contact:

AIDS Action Council
1875 Connecticut Avenue NW #700
Washington DC 20009
202-986-1300, extension 3053
202-986-1345 (fax)
202-332-9614 (tty)

A note from The field of medicine is constantly evolving. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

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This article was provided by AIDS Action Council.
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