Today, Ed Silverman of Pharmalot reviews the opinions of U.S. District Court Judge Richard Leon in a ruling that FDA to exercise appropriate authority over the importation of drugs used for death-row injections.

Most of the U.S. Department of Justice’s major pharma-related decisions invoking the False Claims Act recently have involved illegal marketing and sales. So far, GSK’s is the only one to deal with current good manufacturing practices (cGMP’s).  Read on for a roundup of the top 20 recent cases from Taxpayers Against Fraud (TAF).

FDA has acknowledged that, under former commissioner von Eschenbach, it may have been influenced by the "extreme" and "persistent" pressure applied by four congressmen in approving the Menaflex knee patch. The New York Times goes into more detail:

In the latest installment of a continuing saga, Mylan Labs is suing the two reporters from the Pittsburgh Post-Gazette who alleged Quality violations at the manufacturer's Morgantown, West Virginia facility.

Computer documents have been the downfall of many a company---think Enron.  And things as basic as date and author stamps and wording became very important in Merck's Vioxx case.

A new report conducted by doctors at the University of California-San Francisco claims that pharmaceutical companies are still not being transparent in the reporting of their clinical trials, finding that some are up to five times more likely to report positive findings than negative.

Just read in Pharmalot, that Tufts professor Dr. Carlat (whose New York Times op ed on CME generated so much discussion) has just started up a blog devoted exclusively to this subject.  This blog promises to make for very interesting reading for some time to come (at least, until the much anticipated age of "personalized medicine" finally takes shape).  His first post?  How to sniff out bias in CME.  His suggestions:

Determine the funding source

Analyze which subjects are framed

Look at which studies are featured.

Here's a link.

-AMS