It would be nice if primary care doctors were required to monitor and report adverse side effects from medications; however, they aren’t. Such reports from MDs to the FDA are voluntary:

“The FDA receives adverse drug reaction reports from manufacturers as required by regulation. Health care professionals and consumers send reports voluntarily through the MedWatch program.” - http://www.fda.gov/cder/aers/default.htm

Doctors do file adverse reaction reports with the drug manufacturers (if that’s what you mean by “must monitor”) and the manufacturer then reports the adverse reaction to the FDA.

Ask your family doctor if he/she has ever filed an adverse reaction report directly with the FDA using MedWatch. Odds are they haven’t; the FDA’s Adverse Event Reporting System database is mostly filled with reports from the drug manufacturers.

For years consumers have been able to file an adverse reaction report directly to the FDA or through their doctor, but most haven’t known they could (if they even knew that MedWatch existed). The point of putting the message in the DTC tv ads is to make consumers aware of MedWatch and to encourage them to report adverse reactions they experience to the FDA.

Sam

http://www.fda.gov/medwatch/how.htm

CDER, the Energy and Commerce Committee, the USDOJ, Senators, Congressmen, authorities in the field, pharmacy corporate offices, Senior Services (not because you’re a senior but because they are a ‘get it done’ organization), the VA, the AMA, elected officials on the state level, and of course the offending maker. Find an advocacy group and see if others are reporting problems too.

^ For what it’s worth you can start there. ^
(see, people DO know where to report)

“Last year, the FDA announced plans to study whether TV ads paint an overwhelmingly positive impression, despite audio warnings about potential side effects. And week a House committtee held a hearing about DTC ads. ”

Perhaps the money going to this study would be better spent to more quickly process the data to react to adverse events or unanticipated problems.
To protect the post-marketing public.

What would you suggest be done? And I don’t mean “Be ethical and care about people over profits.” What is your solution for the issues you raise? How much would it cost? Where would the funding come from? How would you deal with unintended consequences (e.g. if your plans had a chilling effect on drug development or availability)?

I’m willing to give you the benefit of the doubt, and so I look forward to your response.