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."
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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)
E-Mail: aidsaction@aidsaction.org
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