Can one person take on the monolithic FDA and get it to actually do something about drug safety? You bet – especially when that person is backed by 56,000 voices.
After weeks of vague answers, the FDA now says it has begun a study on whether TV prescription drug ads should carry a toll-free number and web address where consumers can complain about serious drug side effects.
This news came the same day Consumers Union held a press conference in the Capitol with members of Congress urging the agency put side-effect reporting information on TV drug ads. Pressuring the agency even more were the 56,000 signatures from consumers calling on the FDA to act.
The idea to put the 800-phone number on drug ads comes from activist Kim Witczak, who lost her husband, Woody, to an adverse drug reaction. Kim has spent the better part of her career in advertising; she knows firsthand the power TV ads have over consumers. “Drug ads are everywhere; shouldn’t giving people an easy way to report a problem with their medications be equally available?” she asks.
Rep. Jan Schakowsky took up Kim’s idea, and with other members, worked it into last fall’s FDA drug safety legislation. Print drug ads now must carry the reporting information; and FDA was to study the TV ad issue by March.
We checked with the agency and it appeared no study was underway, until Kim, Rep. Schakowsky, Rep. Rosa DeLauro and CU rolled out the petition signatures.
The pharmaceutical industry – surprise! – is officially mum on the issue, saying it is going to wait for the study before commenting.
But this is common sense: the FDA already has a toll-free number and Web address ready to take the information, called MedWatch (To report negative side effects to the FDA, visit www.fda.gov/medwatch, or call 1-800-FDA-1088.)
The problem is, hardly anyone (a mere 7 percent) knows to report their side effects to the FDA, as a new Consumer Reports poll found. It’s vital that the FDA receives real-time side effect information – Most serious drug safety problems don’t show up until the product has been on the market for years and used by millions.
The easier it is for consumers to know how to report serious side effects, the more quickly the FDA can identify potentially dangerous drugs on the market. The government shouldn’t need another endless study to tell it that.