Iowa PIRG: Victory is ours!
By Meshawn Ayala We won!
President Bush signed our prescription drug
safety bill. The new law will require drug makers to tell the whole
truth about the safety and effectiveness of their drugs by making them
disclose the results of clinical studies. It also will increase
resources for the FDA to monitor the safety of drugs on the market.
Paul
Brown, our advocate in Washington, D.C., told the media, “This bill is
the right prescription for improving the safety of our medicine. We
applaud Congress for putting it on the President's desk and commend him
for signing it into law.”
Thank you for the emails you sent in
mid-summer and again this fall. Those emails – tens of thousands in
total – helped us overcome strong opposition from the drug industry.
Here's a brief excerpt from the Associated Press news story
BUSH SIGNS DRUG SAFETY BILL INTO LAW
By Andrew Bridges
WASHINGTON
(AP) – The Food and Drug Administration on Thursday gained broad new
powers to ensure the safety of prescription drugs used by millions of
Americans under a bill President Bush signed into law.
At its
core, the new law renews for five years programs to collect fees from
drug and medical device manufacturers. The industry money accounts for
about one-quarter of the FDA's overall budget, defraying the cost of
reviewing products that need agency approval.
Members of
Congress, acting in the wake of the withdrawal of the painkiller Vioxx
three years ago, seized on the bipartisan legislation as a vehicle to
reform the FDA's handling of drug safety.
In part, the
legislation shifts more of the FDA's attention from experimental drugs
pending approval to those already are on the market, and gives the
agency more power to act when worrisome problems emerge.
“It really represents an important addition to the FDA's authority,” said FDA commissioner Dr. Andrew von Eschenbach.
It
gives the FDA the power both to require drug companies to do further
study on the safety of medicines, if needed, and to mandate new label
warnings when problems do appear. The FDA also gains the ability to
fine companies to ensure compliance with those two new authorities. The
legislation further requires companies to publicly release results of
all clinical trials that show how well their approved drugs performed.
Not yet approved drugs could be subject to the requirement later.
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Congratulations and thank you once again.
Sincerely,
Meshawn Ayala
Iowa PIRG Citizen Outreach Director
MeshawnA@iowapirg.org
http://www.IowaPIRG.org