Johnson & Johnson

Drugmakers agree to six-month DTC delay

Anne Zieger — Tue, 17 Jun 2008 11:18:05 -0400

Under fire over direct-to-consumer ads, which some Congressional legislators contend are misleading to consumers, pharmaceutical companies have agreed to voluntarily wait six months after drugs are approved before advertising to the public. The Congressmen pressuring the drug companies--Bart Stupak (D-MI) and John Dingell (D-MI)--aren't pleased, however, given that what they wanted was a two year DTC moratorium. Besides, even the drug companies themselves admit that they generally don't advertise within the first six months after product introductions anyway, given that they usually spend at least that much time educating doctors about drugs before beginning consumer advertising. Meanwhile, the pharmas turned down other requests, including that they only advertise products when studies have shown that they improve clinical outcomes (rather than having used biomarkers). (Looks like they gave up a whole lot of nothing, in other words.) The promise to delay on DTC advertising came as part of a hearing focused on ads for Pfizer's Lipitor, Johnson & Johnson's Procrit, and Merck/Schering-Plough's cholesterol drug Vytorin.

To learn more about the hearing:
- read this Wall Street Journal blog item

Related Articles:
Who will pay for DTC pharma ad oversight?
Drugmakers face direct-to-consumer ad ban
AMA to study the impact of drug advertising

Pharmas may be able to drag suits to federal court

Mon, 07 Apr 2008 06:59:58 -0400

Increasingly, consumers who feel that they've been injured by drugs are taking their case to state courts. Their adversaries, the pharmaceutical companies, have long contended that the cases had no place in state proceedings, at least in the case of drugs that had been approved by the FDA, suggesting that federal law should govern such cases. For decades, courts disagreed with the pharmas, but of late, things are turning around. Some observers say that if state courts don't put pressure on the pharmas, they'll have little incentive to disclose post-approval adverse drug effects--but the FDA disagrees.

Now, it seems that the Supreme Court may have the final word. Recently, the Court ruled that many states' suits against medical device makers are pre-empted by federal law. They'll soon rule on a similar case that could make pre-emption the standard for drug cases, too. This could have a dramatic effect on actions such as the flood of state suits against Johnson & Johnson, which has been sued by more than 3,000 women and their families, all claiming that its FDA-approved Ortho Evra patch caused harm by delivering much more estrogen than expected.

To learn more about this trend:
- read this New York Times piece

Related Articles:
CT attorney general sues FDA over OxyContin. Report
Supreme Court makes it harder to sue device makers. Report