Common sense shouldn’t take two years – unless it’s the FDA

Rate this post

Should it really take two years to study a common-sense proposal to make drug ads better for consumers? Not unless it’s the Food and Drug Administration, which has taken foot-dragging to new heights.

The FDA commissioner recently sent a letter to Congress claiming it would take two years to study whether all drug ads on TV should include a toll-free number and website where consumers can report serious side effects to the agency. This, even though Congress required drug ads in magazines and newspapers carry the same reporting information, and told the FDA to study the TV proposal within six months.

I spoke out against this delay last week at the FDA’s Risk Communication Advisory Committee meeting, which is debating the issue and will make a recommendation to the agency. Those of us in support agreed that the more real-time information the FDA has about serious side effects, the more quickly it can evaluate the safety of drugs on the market.

The problem is, most people have no idea how to let the FDA know about the serious side effects they experience. I told the panel about Consumer Reports’ recent poll that found only 7 percent of Americans would report a side effect to the FDA. That same poll found that 87 percent thought it was a great idea to put the reporting information on TV ads.

I also told the committee about our petition signed by 56,000 of you in support of the effort (thanks again for your work).

It seemed most of the panel members agreed that two years is way too long for the FDA to decide this. A few expressed worry that having this information in TV ads would tie up the FDA’s phone lines with reports of minor side effects, though most supported the idea.

I think if anything, it’s going to increase sensitivities to risk,” said Christine M. Bruhn, a consumer food marketing specialist at the University of California, Davis. Bruhn also suggested the FDA consider using the number 1-800- SIDE EFT.

Kim Witczak, founder of the drug safety group WoodyMatters, also asked the committee to consider running Public Service Announcements (PSAs) while the study is in progress to inform consumers that they can report side effects to the FDA. Kim is the one who came up the idea of putting reporting information on drug ads in the first place. She knows how effective drug ads are – Kim has spent the better part of her career working in advertising.

In light of the FDA commissioner’s two-year study timetable, we need to keep the pressure up on the advisory committee. Please take a few moments to email your thoughts to the panel about why its so important the public knows how to report serious side effects.

Common sense – even for the FDA, two years is too long.