First consumers, now Congress. Two lawmakers asked the FDA yesterday to mandate that all TV ads for prescription drugs include contact info for patients to report serious side effects to the agency. The impetus? A Consumer Reports poll that showed 16 respondents had a side effect serious enough to send them to the doctor or hospital--but 35 percent of respondents didn't know they could report side effects to the FDA.

FDA tracks side effects from prescription and OTC meds, but officials estimate they learn about fewer than 10 percent of drug reactions. Consumers Union, which publishes Consumer Reports, sent the agency a petition with 55,000 signatures, requesting that a toll-free number and web address be included in TV drug ads. An agency spokeswoman said it's reviewing the petition.

Already, Congress passed legislation requiring contact info to be placed in all DTC print ads and calling for an FDA study of doing the same in TV commercials. That study is still ongoing, the spokeswoman said.

- check out the Consumers Union survey [1]
- read the Los Angeles Times story [2]
- see the item [3] in the WSJ Health Blog

ALSO: The FDA appears to be close to unveiling its plans for a national surveillance network to keep tabs on drug safety. The "Sentinel" project has to address a number of key questions first, though. Such as, how will prescription info be kept private and secure? And how will the system be insulated from political and industry influence? Report [4]

Related Articles:
FDA to study TV drug ad imagery. Report [5]
Survey: No doubt DTC ads work. Report [6]
Watchdogs circling DTC drug commercials. Report [7]
Study: DTC ad spending on the rise. Report [8]
Does the FDA do enough to regulate drug ads? Report [9]