AMA calls for tighter DTC regulation

We all expected Democrats to rake DTC ads over the coals during yesterday's hearing before the House Energy and Commerce Committee's oversight arm. We expected Chairman Bart Stupak to call for tighter controls on the ads. What we didn't expect was for the American Medical Association to join the fray. President-elect Nancy Nielsen told lawmakers that the FDA should be given more authority to pre-approve DTC ads. Striking directly at drugmakers' usual defense of the ads as "educational," Nielsen said, "It is frankly clear that the majority of what's happening has a marketing effect and not an educational effect."

Nor did we know that the feds' own watchdog, the Government Accountability Office, would say the FDA isn't completely effective at regulating those ads; the agency takes more than six months to issue warnings about ads that violate the rules.

During the hearing, ads such as those for Merck/Schering-Plough's Vytorin and Johnson & Johnson's Procrit were called misleading and not completely truthful. Pharma officials struck back, saying that the claims made in those ads were "supported by research" (M/S-P) and "true, responsible, and substantiated by scientific studies" (J&J). And Republicans on the committee said the (unfunded) standards Congress set last year for drug commercials should be paid for and given a chance to work.

- read the AMA's press release
- see the story from ABC News
- check out the USA Today piece
- read the Star-Ledger article

ALSO: The feds need to add rules governing drug product placements, too, according to a report from University of California-Los Angeles researchers. Report

Suggested Articles

CEPI, which started to help prepare the world for new outbreaks, has awarded Inovio and Moderna money for vaccine work against the new coronavirus.

The real estate impresario that built a chain of upscale drug recovery facilities is now building a gene and cell therapy CDMO near Philadelphia.

The seven-year Astellas venture served as a model for Amgen's recent $2.7 billion tie-up with BeiGene in China—and now it's amping up there, too.