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