FDA urged to push hotline for side effects

A free hotline for patients to report serious medical side effects should be mentioned in television commercials and also needs to be more widely promoted on pill bottles and pharmacy packaging, U.S. health experts said on Friday.

The Food and Drug Administration should also consider making its own television ad—a public-service announcement—to educate patients about drug and device risks, a panel of outside advisers to the agency said.

“You’ve got to make it real easy for folks to report this information,” Cheryl Holt, a University of Alabama professor of preventive medicine, said at a meeting held to discuss the FDA’s hotline for complications.

The 1-800-FDA-1088 number is part of the agency’s MedWatch program to monitor possible problems with drugs and devices. Consumers and doctors can also report concerns on the FDA’s website.

Last year, Congress required information on the program for print advertisements targeting consumers and called for the agency to study whether it should also be included in TV ads.

The final decision will be made by the Department of Health and Human Services secretary after the FDA completes its study. Congress had called for the study to be done within six months, but the FDA said it will take up to two years to finish.

Consumers Union and other patient advocates have said there is no question patients would benefit if the information was in widely-seen television commercials.

“If it’s good enough for print, it seems it should be good enough for television,” Kim Witczak, head of the group Woody Matters, that pushes drug safety reform, told the meeting.

Some industry representatives have said the hotline details could detract from other information and confuse viewers.

Peter Pitts, head of the Center for Medicine in the Public Interest, which received industry funding, told panel members the FDA should consider limiting the hotline to commercials for higher-risk products.

The FDA’s panelists, for the most part, said the extra information would help reinforce a product’s potential risks.

But they also had some doubts about how well patients would remember details from brief TV ads, which can last less than a minute. Wider promotion could also leave the agency struggling to sort through an influx of calls, they added.