Ortho Evra

ALSO NOTED: PA schedules hearings on Independence/Highmark merger; Medical college group urges caution with pharma tech freebie

Tue, 13 May 2008 06:59:50 -0400

> More than a year after the deal was proposed, the Pennsylvania Insurance Department has (finally) scheduled hearings to review public comments on the proposed merger of Independence Blue Cross of Philadelphia and Highmark Inc. Article

> A group representing U.S. medical colleges argues that while the pharmaceutical industry's technology gifts aren't getting as much attention as other freebies, they should be. FierceHealthIT

> Darn that pesky Public Citizen--its members get around. One day it's calling for the withdrawal of the Ortho Evra patch from the market, and now leading light Sidney Wolfe, M.D. is helping the FDA scrutinize expanded use of the painkiller, Fentora. FiercePharma

> The former CEO of Atlanta's Grady Memorial Hospital has filed a suit alleging that the hospital's chairwoman set up his firing so she could take his job. Article

And Finally... Clearly, he was overcome by the Dark Side of the Booze. Article

Group asks FDA to pull birth control patch off market

Fri, 09 May 2008 06:59:58 -0400

Arguing that it's a far riskier treatment than the pill, consumer advocacy group Public Citizen has asked the FDA to pull the birth control patch Ortho-Evra off the market. Over the last few years, health risks associated with the weekly patch have been discovered, including higher rates of blood clots than women who took birth control pills. This is thought to be the case because patients absorb up to 60 percent more estrogen with the patch. Since 2005, the FDA has updated the patch to include clot warnings but otherwise left the drug alone. On the other hand, the warnings may have had some effect, as demand for the patch has dropped from 9.9 million scripts in 2004 to 2.7 million in 2007.

In the mean time, there's been a flood of state suits against patch-maker 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 the group's request:
- read this Associated Press item

Related Articles:
Pharmas may be able to drag suits into federal court
FDA issues warning for Ortho Evra patch
Patch delivers killer doses

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