Sunday, July 20, 2008

Immunity?

Since the Supreme Court granted immunity to Medical Device manufacturers in February, there has been heightened discussion about the court taking the next logical step, granting immunity to FDA approved medications, which may occur in the next Court session.

Pharmablogger will devote additional coverage and discussion to this issue in the coming months. For an interesting contrast of media coverage, see July 18th edition of the Philadelphia Inquirer. In the same paper, there was a slightly paranoid sounding article about a meeting in Philly between Pharma execs, attended by a "high ranking official" from the FDA, who was the featured speaker on the topic of immunity. The points about faulty FDA review were spot-on, but PB wanted to specifically call out one sentence: "These corporations will cry that complete immunity pre-emption is necessary because the cost of litigation is suppressing their research and development. That is a lie. " Amen. One of the best-selling pharmaceuticals in the country is an anti-schizophrenia medicine, which has already had one large line extension with bipolar disorder, and the company is seeking approval for an even larger extension with a claim for general anxiety disorder, and major depression. The patient population for this drug could explode even more, with GPs prescribing it. Yet this drug is also a huge litigation magnet for this company already. No matter - full (development) steam ahead.

The second Inky article is about Merck's approval of a settlement sum for Vioxx litigants - $4.5 billion. Now, PB has no journalism experience, and the first article seemed timely based on the meeting that the author discussed. But is it possible that the Inky held the editorial for a short while, knowing that a Merck decision on the settlement funds was imminent? Just wondering.

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