The Supreme Court last Wednesday decided the first of an important series of cases having to do with whether FDA approval and regulation preempts lawsuits at the state level. The case was Riegel v. Medtronic, and it had to do with a balloon catheter that burst during an angioplasty. Though it’s a device case, not […]

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“FDA Seeks to Broaden Range of Use for Drugs” read a headline in this past weekend’s New York Times. You’d be forgiven if you thought the article was about FDA trying to broaden the use of drugs—but in fact it was about something quite different: a new FDA draft guidance that would change the rules […]

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We read a lot of critiques of the pharma industry, and frankly many of them leave a lot to be desired in terms of logic, clarity, and thoughtfulness.
For an example of the opposite—a truly clear and scorching attack, let us recommend to you a document prepared by Dr. Joseph Glenmullen, a Clinical Instructor in Psychiatry […]

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European news sources are reporting that European Union officials conducted surprise dawn raids Wednesday at the offices of a number of pharmaceutical companies, including Pfizer, GlaxoSmithKline, Sanofi-Aventis, AstraZeneca, Merck Sharp & Dohme, Johnson & Johnson’s Belgian unit, Wyeth, and Novartis’ Sandoz division.
What’s the beef? Reports say the EU is looking for evidence of […]

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A key legal issue for pharma these days is whether FDA approval preempts liability lawsuits at the state level. Three cases are wending their way toward the Supreme Court, of which the most important is arguably Wyeth v. Levine, a suit concerning Wyeth’s antinausea med, Phenergan (promethazine). Over the holidays, the Solicitor General released an […]

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