By Reed Cooley, CQ Staff

To increase awareness and accessibility of the Food and Drug Administration’s reporting program for drug side effects — MedWatch — nearly 56,000 consumers have signed a Consumers Union (CU) petition asking FDA to mandate the inclusion of a toll-free number and Web site for reporting serious side effects in all TV drug advertisements.

The petition comes on the heels of a Consumer Reports poll that showed that “one in six Americans who have ever taken a prescription drug have experienced a side effect serious enough to send them to the hospital, but the majority of consumers don’t know they can report these side effects to the FDA,” according to a CU press release.

“Direct-to-consumer advertising has exploded in this country since it was first allowed in 1997, and, not coincidentally, so has prescription drug use,” said Rep. Jan Schakowsky , D-Ill.

Last summer, Schakowsky cosponsored an early version of the FDA Amendments Act (PL 110-85), which passed in September and required all print drug advertisements to include reporting information.

The bill also called for the FDA to conduct a study to address the feasibility of including such information in TV ads, but so far no such study has been done, the release said.

Among participants in the Consumer Reports poll, 81 percent reported having seen or heard an ad for prescription drugs in the last 30 days, but only 35 percent were aware of the MedWatch reporting program.

A spokesperson for the Pharmaceutical Research and Manufacturers of America (PhRMA) said the drug company would not take a position on the petition until FDA completes its study on the feasibility of including reporting information in television ads.

Rep. Rosa DeLauro , D-Conn., has introduced legislation that would ban ads for three years after a drug is approved for market use to allow adverse side effects to come to light before aggressive marketing to consumers.

“There is no doubt that the more we know about potential risk and drug side effects, the more we can do to protect consumers,” she said at the CU press conference.

DeLauro also noted that pharmaceutical advertising spending nearly doubled from $650 million in 2001 to $1.1 billion in 2005.

Reps. Schakowsky and DeLauro both said they are working with the FDA on this issue but that neither of them had signed the CU petition.