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Petition Asks FDA to Make it Easier for Patients to Report Side Effects from Prescription Drugs

Seeks toll-free number, Web address on all TV ads to report adverse reactions

(Washington, D.C.) – Citing consumer frustration with TV ads that sell the “good news” about prescription drugs but gloss over side effects, Consumers Union is collecting 50,000 signatures on a petition to the FDA demanding the agency make it easier for patients to report problems with their medications.
The citizens’ petition requests the Food and Drug Administration require all TV ads for prescription and over-the-counter drugs include a toll-free number and Web address so the public can easily report adverse events.
Last September, Congress approved a major drug safety bill requiring that all drug print ads include adverse event reporting information, but left it to the FDA to conduct a study by March 2008 to determine if such information should also be included in TV ads.
“If the FDA is really serious about finding out how drugs work in the millions of people who take them each day, it should make it as easy as possible for consumers to report side effects,” said Kim Witczak, founder of the drug safety group WoodyMatters and co-author of the petition.
“Safety problems sometimes emerge when a drug is on the market and taken by millions of people. Adverse event reporting can provide the FDA with real-time information about problem medicines,” Witczak added. “Drug ads are everywhere; shouldn’t giving people an easy way to report a problem with their medications be equally available?”
New drugs are heavily advertised on TV, with only short-term information about their safety profiles. Two-thirds of all drug withdrawals from the market happen in the first three years following approval. Adverse event reporting by consumers is vital to signaling safety problems, but the FDA’s reporting system, MedWatch, catches only a fraction of negative side effects.
In 2005, about 465,000 adverse events were collected by the FDA, even though drug reactions account for nearly 700,000 emergency room visits each year. And studies indicate that millions of people suffer side effects potent enough to lead them to stop taking a drug.
Drug makers are required to report adverse events to the FDA. Yet doctors and patients – those with the most direct experience with side effects – seldom report them, and little is done by the FDA to make consumers more aware of the importance of reporting side effects. An Institute of Medicine report found that in 2004, only 21,500 of the 423,000 adverse event reports that year came from doctors and patients.
“The average TV viewer spends about 100 minutes watching drug ads for every minute spent in a doctor’s office. What better way than to let consumers know how to report a problem with their medications than to put a phone number or Web address in those ads?” said Liz Foley, grassroots coordinator with Consumers Union, publisher of Consumer Reports.
Contacts: Kim Witczak, 612-877-0570
Susan Herold, CU, 202-462-6262
Liz Foley, CU, 914-378-2421