Medicare Compliance & Reimbursement

TV ads must provide info on reporting drug problems, group insists

A leading consumer organization is rallying support to force the feds to make it easier for patients and doctors to report adverse drug affects.

Consumers Union, which publishes Consumer Reports, is collecting 50,000 signatures on a petition to the Food and Drug Administration, citing customer frustration with television ads that sell the "good news" about prescription drug but overlook the adverse effects of the drugs, the non-profit group reported in a press release.

In the petition, the Consumers Union calls on the FDA to make it mandatory for all television ads for prescription and over-the-counter drugs to mention a toll-free number and Web address to make it easier for consumers to report problems or adverse side effects of medicines. 

Congress passed a significant drug safety bill in September 2007, which made it obligatory for drug print ads to include adverse event reporting information.

TV ads were exempted from the regulation, and the FDA was authorized to find out by March 2008 if the same information should be required for them.

"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 Witczat, founder of the drug safety group WoodyMatters and co-author of the petition.

"Drug ads are everywhere; shouldn't giving people an easy way to report a problem with their medications be equally available?" Witczat added. Such an arrangement would provide the FDA with real-time information about problem medicines.

There is wide-scale advertising of new drugs on TV, but the ads do not include adequate information about their safety profiles. Two-thirds of all drugs removed from the market were pulled in the first three years after approval. Consumers' feedback on adverse events is crucial for signaling safety problems.

And MedWatch, the FDA's reporting system, reports only a small portion of side effects, according to the Consumers Union release.

In 2005, 700,000 emergency room visits were reported because of drug reactions, whereas the FDA collected only 465,000 adverse events.

Research has shown that many people suffered side effects so strong that they had to discontinue the drug.

Drug manufacturers are supposed to report adverse drug effects to the FDA. However, the FDA is making no significant effort to encourage doctors and patients--who have the most direct experience with side effects of drugs--to report these events, the release says.

An Institute of Medicine report revealed that out of 423,000 adverse events reported, only 21,500 came from doctors and patients.

"The average TV viewer spends about 100 minutes watching drug ads for every minute spent in [...]