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Rep. Waxman And Rep. Markey
Introduce Counterpart To Enzi-kennedy Drug Safety
Bill
Today Representatives Henry A. Waxman (D-CA) and
Edward J. Markey (D-MA), two senior members of the Energy and
Commerce Committee, announced the introduction of H.R. 1561, the
House counterpart to the Enzi-Kennedy Enhancing Drug Safety and
Innovation Act of 2007 (S. 484). H.R. 1561 builds on the Senate drug
safety bill to further increase FDA's post-market drug safety
authority, provide greater FDA transparency, and enhance the
mandatory clinical trial database created in the Enzi-Kennedy
bill.
"We need only look to recent high-profile post-market
safety problems, like Vioxx, to know that our drug safety system is
in desperate need of some serious improvements," Rep. Waxman said.
"We also cannot continue to allow drug companies to cherry-pick and
distort the clinical trial information on which physicians rely
about which drugs work and the risks those drugs pose. The
Enzi-Kennedy bill is a significant step forward in addressing these
concerns. Our legislation goes even further in giving FDA the full
complement of tools it needs to protect our citizens from unsafe
products."
"In the wake of Vioxx, Paxil, Ketek and other
drug scandals, Congress needs to act now to improve drug safety at
FDA," Rep. Markey said. "I am proud to cosponsor this legislation
with Representative Waxman, who has long been a leader on reforming
the FDA. As the Congress moves forward with the reauthorization of
the Prescription Drug User Fee Act, I hope to build on this broad
package of reforms to further ensure a culture of scientific
integrity and transparency within the FDA and enhance the role of
the drug safety experts who work in the office of drug surveillance
and epidemiology within the FDA."
Rep. Waxman and Rep.
Markey's legislation makes several important improvements to the
Enzi-Kennedy legislation, including:
- Gives the FDA
enhanced tools to ensure post-market drug safety through the "Risk
Evaluation and Mitigation Strategy" (REMS) process, including: (1)
increasing the possible moratorium on direct-to-consumer advertising
from two years to three years; (2) adopting the IOM recommendation
that the FDA place a symbol on the packaging of a product to let
consumers know that the drug is new to the marketplace; and (3)
requiring a review of drug products after they have been on the
market for 7 years (the average time it takes to detect most side
effects);
- Increases the transparency of the REMS review
process and creates a public record of any disputes brought before
the Drug Safety Oversight Board;
- Enhances FDA's enforcement
authority by giving the FDA the ability to impose civil monetary
penalties if drug companies fail to comply with any requirements
relating to drugs in the Federal Food, Drug, and Cosmetic Act and
increasing the amount of those civil penalties;
- Provides
for a balance between funding from user fees and federal dollars in
FDA's drug safety budget by authorizing $25 million for each of
fiscal years 2008 through 2012 in addition to other funds available
for carrying out Title I activities;
- Requires the FDA to
report to Congress on its efforts to integrate the expertise of the
Office of Surveillance and Epidemiology (formerly Office of Drug
Safety) into the Agency's approval, labeling, and post-approval
safety decisions; and
- Strengthens the clinical trials
registry and results databases to include more information on more
trials (including medical devices), and gives the Secretary the
added ability to impose civil monetary penalties for non-compliance.
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