Pre-pre-emption report shows divide in FDA over labeling regs

Several top FDA officials objected to the agency’s rewrite of labeling rules in 2006 and 2008, which have made it harder for drug companies to include new safety risks on drug labels and thus be held liable for missing information, says a report released this week by the House Committee of Government Oversight and Reform. The rewrites under the Bush administration attempt to strip away drugmakers’ liability for safety issues not included in the labeling of approved drugs – plus a ‘preamble’ that argues that the new rules preempt state lawsuits.

The report, which comes a week before the Supreme Court will hear the watershed preemption case, Wyeth v. Levine, shows strong intra-agency disagreement and evidence of a push from the Bush administration to secure the language of regulatory preemption.

For more, see the Wall Street Journal, Pharmalot and FiercePharma posts.

Would you like generics with that?

The AP looks at the incentives on offer from some insurance companies to doctors who switch patients to generic drugs (steak and ale, in this case), a practice frowned upon by those in the medical community who say the prescribing pad should be the sole purview of the doctor.

“On either side you’ve got corporate bottom-line interests putting pressure on physicians who should be putting patients first,” Dr. Jean Silver-Isenstadt told the AP. Silver-Isenstadt is the executive director of the National Physicians Alliance, a partner group of RxP that encourages physicians to unbrand themselves from both industry and insurers. Check out their Unbranded Doctor campaign here.

Merck says Rosetta will swap coasts

The Scientist blog and Forbes Science Business blog mull the announcement that Merck biotech subsidiary Rosetta Inpharmatics in Seattle will be closing its doors – both bloggers, it seems, grew a bit nostalgic for brighter days at Rosetta, and worried for scientists they knew there. But wait! Hold the flowers, Merck tells The Scientist blog: The division is merely being incorporated into the parent company’s Boston labs – that is, if Merck can convince the researchers who work there to trade their homes in Starbucks City for the Land of Dunkin’.

…And speaking of Boston (since it’s a light news week), we were amused to catch a recent episode of Boston Legal that  got at some issues we here at RxP are pretty well-acquainted with.  In a court room, in a world not so very different from this one, TV-lawyer Candace Bergen went on a serious riff about conflicts of interest in academic medicine.

Maybe, just maybe, show creator (and Boston native) David E. Kelley penned Bergen’s jury speech after soaking up the news in our own Weekly Reader. Then again, perhaps we’re trying too hard to make the RxP-Hollywood connection.

BREAKING NEWS: Sandusky farmer says pumpkins have regrouped along party lines.