December 2007
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 THE CONSUMERS UNION PERSPECTIVE
Here, a monthly perspective from Consumers Union on the latest challenges—and possible solutions—facing U.S. consumers today. See archived letters.



Winning a fight for stronger drug-safety laws

Kim Witczak on computer
It's personal Kim Witczak's husband killed himself while on antidepressants.
When Kim Witczak of Minneapolis talks about a new federal law that aims to make prescription drugs safer, you realize the issue is personal." If only some of these changes were in place four years ago, I truly believe my husband would still be alive today," says Witczak, who joined Consumers Union's campaign for drug-safety reform. She believes antidepressants led to her husband's suicide.

In September, Congress passed and President Bush signed into law what is considered to be the most sweeping drug-safety legislation in nearly 45 years. The law, prompted in part by problems with the pain medication Vioxx and the antidepressant Paxil, will require results from clinical drug studies to be made public so that consumers and doctors will know the good and bad news about medications.

Within 18 months, drugmakers will have to post comprehensive summaries of the results of their drug trials on the Internet. The data will be vital to researchers and doctors. It will include information about how a drug performed when tested on humans, and later, information on the drug's side effects.

The Food and Drug Administration will have the power to require a drug company to change its warning labels if safety problems emerge, and to make the company run additional safety studies. Until now, the FDA could ask drugmakers to do follow-up studies but usually couldn't require them. As of last year, some 899 studies had yet to be completed by drug manufacturers.

While you'll still see plenty of drug advertisements, the FDA will have the authority to regulate them more strictly. (A CU-backed measure that failed would have let the agency temporarily ban ads for new drugs that raised safety concerns.)

A provision proposed by Witczak was included in the final bill. All print ads will include a toll-free number and Web site address so consumers can more easily report negative drug reactions to the FDA.

Current FDA panels that recommend drugs for approval often include members with financial ties to the companies whose medications are under consideration. The new law decreases the number of panel members with industry conflicts by some 25 percent over five years. (CU supported a ban on any committee members with conflicts.)

Consumers Union will continue working for reforms to give Americans the drug-safety system they deserve. One focus: More than half the FDA's drug-approval budget comes from the pharmaceutical industry with strings attached. If the FDA can't be fully funded by the Treasury, as most other government agencies are, then any money that does come from the pharmaceutical industry must come without restrictions or industry-imposed timetables.