We’ve complained before about the federal government’s monetization of First Amendment violations in the context of truthful promotion of off-label uses:
[T]he government has ruthlessly monetized its questionable ban on truthful off-label promotion for quite a few years now. Indeed, the government has used this ban as the basis for a creeping administrative takeover of
Researchers at Temple University here in Philly recently published a scientific article, “Learning Impairments, Memory Deficits, and Neuropathology in Aged Tau Transgenic Mice Are Dependent on Leukotrienes Biosynthesis: Role of the cdk5 Kinase Pathway,” in the scientific journal Molecular Neurobiology. That sounds pretty dense, but what the article concludes is that the generic drug
Today’s guest post by Reed Smith associate Jennifer Eppensteiner concerns an interesting First Amendment development. Everybody knows how California’s wildly overwrought Proposition 65 has turned that state’s products, from beer to bacon, into billboards for remote and scientifically suspect cancer warnings. Well, how about a ruling that requiring scientifically unsound warnings on products is compelled
Like a lot of large firms, Reed Smith has a number of blogs. We don’t mention them much because, DDL has product liability pretty well covered, and the others mostly don’t overlap a lot with what we do. But occasionally….
The other day, Reed Smith’s Health Industry Washington Watch blog described a couple of pieces
We’ve been aware of the other side attempting to construct a First Amendment counter-argument to our preemption defense for some time. It first cropped up in a 2015 360 article by a P-side thought leader (no, not necessarily an oxymoron) soon echoed by a comment to one of our posts on the Amarin First Amendment
Last week, we summarized PhRMA’s comments on the FDA’s proposed amendments to regulations regarding “intended uses.” PhRMA showed how the FDA’s insistence that it could read manufacturer’s minds about intended uses made no sense on an evidentiary basis and ran afoul of First Amendment considerations. Today, we’ll tip our cyber caps to the Advanced Medical
The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory two-step, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use – making the product
Enough things – well, three, anyway – about off-label use have piled up in our inbox to warrant yet another point of the subject. In case anybody has forgotten, our basic views about off-label use are: (1) on the whole, it’s far more medically beneficial than not and often represents the medical standard of care;