Joint Statement of Science, Public Health, and Consumer Groups,
November 16, 2006
The Enhancing Drug Safety and Innovation Act is an important
effort to respond to consumers' increasing concerns about the
inadequacy of current safeguards protecting the public from unreported
risks of prescription drugs. The above science and consumer health
groups urged the Senate HELP Committee to consider a full range
of drug safety reform proposals before acting on any legislation.
The committee is holding a hearing today on the Enzi-Kennedy bill,
but the groups have recommended numerous alternative legislative
provisions and strategies that they urged the Senators to consider
adopting, including suggestions contained in the recent IOM report,
a survey of FDA scientists conducted by the Union of Concerned
Scientists, a report by the National Research Center for Women
& Families, recent articles by FDA experts, and bills introduced
by Senators Grassley and Dodd, and by several members of the House
of Representatives.
We are deeply concerned about the weakened safeguards at the FDA,
and believe that in the coming months there will be an important
opportunity to review the information and recommendations that
have been made in the last few months and incorporate some of
these suggestions into new, stronger legislation.
Moreover, we urge that the HELP Committee develop legislation
to increase resources for safety reviews and surveillance, before
and after FDA approval decisions are made. The current user fee
law (PDUFA) restricts almost all user fees for use in speeding
the review of products, permitting only a miniscule percentage
to be used for the review of safety data. We are especially concerned
that the bill shifts the safety focus from before an approval
decision is made to post-market surveillance and studies conducted
after a drug is approved for market.
Based on these concerns, we urge the Committee and the full Senate
to take the time necessary to examine these proposals thoroughly,
and to significantly revise and strengthen any FDA legislation
that moves through the Senate this year and in the next Congress.
Center for Medical Consumers
Center for Science in the Public Interest
Government Accountability Project
National Research Center for Women & Families
National Women's Health Network
Title II Community AIDS National Network
Union of Concerned Scientists
Victim Advocates: Eric Swan and Kim Witczak
