Will DTC hearing lead to new regulation?

Will today's Congressional hearing on drug ads lead to new legislation [1]? That's what Michigan Democrat--and vocal pharma critic--Bart Stupak (photo [2]) hopes. The chairman of the House Energy and Commerce's subcommittee on oversight says he'd like to tighten controls on drug marketing to consumers. For one thing, he'd give the FDA power to force changes in TV ads before they're aired.

Of course, Congress has tried before to stiffen DTC rules, but the TV industry--which reaps billions from the ads--and pharma lobby have fended off those changes. But several recent controversies may aid the reform cause this time. Merck and Schering-Plough have drawn fire [3] for heavily promoting their Vytorin cholesterol drug while dragging their feet on data that questioned its effectiveness. Pfizer pulled its Lipitor campaign [4] when critics assailed its use of artificial-heart inventor Robert Jarvik. And then, says Stupak, there's Johnson & Johnson, which advertised its anemia med Procrit as an anti-fatigue drug, a use for which it was not approved. The FDA repeatedly asked J&J to revise those commercials, but the company didn't. Stupak told the Wall Street Journal: "They advertised this for seven years."

J&J disputes that assertion, saying that the commercials were accurate and consistent with their FDA-approved labeling at the time. But expect to hear more argument of these points during today's hearing, which you can watch on the committee's website, among other places.

- see the Wall Street Journal article [5]
- find the video link [6] at the committee website

Related Articles:
Stupak plays bad cop against pharma [7]
DTC hearing has high-powered guest list [1]
To DTC or not to DTC? [8]
FDA to study TV drug ad imagery [9]
Survey: No doubt DTC ads work [10]