Tell Congress: Stand up for patients, not drug companies!

Strengthen S.1082 when it gets to the Senate floor for a vote!

Dear Senator,

You will soon be voting on an extremely important issue to me and my family: S 1082, the Food and Drug Administration Revitalization Act. I urge you to do all you can to ensure the drug safety provisions incorporated into this measure are as strong and effective as possible, including offering and supporting amendments to improve the bill.

It has been more than two years since it was revealed the makers of Vioxx and Paxil knew about the deadly side effects of their drugs, but failed to reveal that information to the public. Yet today, the law still allows drug makers to keep studies from the public that could alert doctors and patients to dangerous side effects.

S.1082 would address this and other major gaps in our drug safety process, which many of the nation's top researchers, doctors and consumer groups have said is broken. In fact, the Institute of Medicine issued a report highly critical of the FDA's ability to perform its drug safety mission. Some of the IOM's recommendations are included in this legislation, but not all.

Please take this once-in-a-lifetime opportunity to show the public that Congress takes seriously its commitment to getting safe and effective drugs on the market. None of these measures will slow the flow of important, life-saving drugs to patients. Rather, a strong bill will help ensure that the medicines my family takes are as safe and effective as possible.

I urge you to push for the following improvements in the bill:

1. Ensure that clinical trial registration and publication of results applies to all Phase II, III and IV trials (Phase II trials are partially exempted in the bill), and require publication of results within a set period of time, ideally no more than a year after completion of a trial, to avoid foot-dragging by industry. Also, all clinical trials completed before passage of the bill should be made available to the public, so we can know the full pros and cons of a drug.

2. A higher level of civil monetary fines, and public listing, of those companies that do not comply with FDA drug safety requirements. Pharmaceutical companies make millions in profits on FDA-approved drugs, and small fines likely will not serve as a deterrent.

3. More resources for the FDA so the agency can do its job. Increased resources will help ensure all drug advertising is reviewed, reports of safety problems analyzed, patients in clinical trials are protected from unnecessary dangers, follow-up safety studies are conducted and FDA's ancient computer system modernized.

4. Openness and public participation in the negotiations between the drug companies and the FDA on safety disputes, and development of risk evaluation and management strategies. It is important that safety disputes not be conducted behind closed doors, and that the public quickly be made aware of serious safety risks when they arise.

5. Require that drugs commonly used off-label are studied for safety of those uses. This will do nothing to discourage doctors from off-label prescribing, but rather, will put science behind these decisions.

6. Create a system where FDA doctors and scientists can express their concerns about drug safety without fear of retaliation.

I ask that you work to strengthen S. 1082 by supporting the improvements listed above.

Thank you for your consideration, and I look forward to your support and response.


Sincerely,

[Your Name]
[Your Address]
[City, State ZIP]