The Food and Drug Administration Amendments Act of 2007 (H.R. 3580)

Congress gave final approval Thursday, November 20, 2007  to legislation designed to transform the Food and Drug Administration from a passive monitor to an active detective seeking out medications that have been approved for sale but turn out to be hazardous.

The Food and Drug Administration Amendments Act of 2007 (H.R. 3580) passed by unanimous consent in the Senate after the House overwhelmingly passed it the day before, and the bill has been signed into law by the President.

 

Thank you for for supporting CCHR, helping it and its allies achieve what the media are heralding as the, “most significant drug safety legislation in more than 40 years.”

Overcoming unbelievable obstacles, and working with many consumer and parents groups and whistleblowers, in a nutshell the following is some of what was achieved:

§         Drug ads will now carry a conspicuous notice: “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.”  Until now, over 90% of Americans didn’t know that they could bypass their psych or MD to report adverse drug reactions (ADRs) to the FDA (because psychs/doctors only report 1-10 percent of drug side effects.) Empowering people with the ability to report side effects themselves and the ADR reports could increase 100x! And $225 million is to be allocated to ensure that the FDA does oversee the adverse reactions and acts on them!

§         Drug companies must now publicly post all results—the good, bad and the ugly—of their drug clinical trials on the Internet. They can no longer selectively choose what they want you to know. The posting will include a glossary for the lay people explaining technical terms to ensure that such information is not misleading or misunderstood.

§         If any drug maker submits false information on a clinical trial, the FDA will post a notice stating: “The entry for this clinical trial was found to be false or misleading and therefore not in compliance with the law.”

 

§         The FDA must now monitor drug advertisements and if they are false or misleading, can fine drug makers up to to $10 million.

 

You can see that your support of CCHR is getting dynamic RESULTS. Please continue to support CCHR with your donations and your volunteer efforts.

 

Think psychiatrists don’t
know their drugs
cause violence?
Think again.