We’ve posted more times than we can count in support of the position that FDA-regulated manufacturers should be able to engage in truthful “promotion” of the off-label uses of their products. Well, on nationwide TV – and in the presence of the Commissioner of the FDA – on March 19, 2010 the President of the
Indulge us for a moment as we recount another airline adventure. Recently, we traveled thousands of miles to an important argument. Our first flight boarded right on time, left the gate right on time, and taxied down the runway . . . partway. Then stopped. Enter the inevitable announcement: “Ladies and gentlemen, we’re very sorry,
On March 5, FDA Commissioner Dr. Scott Gottlieb abruptly announced his resignation, effective in a month. Since then, it has been announced that Dr. Ned Sharpless, currently head of the National Cancer Institute, will replace Dr. Gottlieb on an “acting” basis. This is disturbing generally, as Dr. Gottlieb has stood out as a demonstrably
We’ve been waiting quite a while for the FDA to modernize its positions on the truthful off-label communications by regulated manufacturers. Under current First Amendment practice, the FDA’s positions are quite likely unconstitutional as both speaker- and topic-based restrictions on the truthful communication of scientific information. However, the best we’ve seen from the Agency to
We all know the phrase “the elephant in the room.” There are some things that do not get mentioned that are so obviously relevant that silence about them, or willful ignorance of them, can be humorous or frustrating. Based on our not-so-extensive research, we see that the origin of the fairly widespread use of this
As we roll out of bed on the day after Thanksgiving, we are often confronted with contradictory thoughts. For instance, “why did I have that third plate at dinner?” might be followed by “How can I eat some leftovers for breakfast?” Leftovers are as much of an American tradition on this day as watching videos
Although they have nothing to do with the Affordable Care Act, health-care-related so-called “death panels” do exist. These panels are operated by state agencies and private health insurance companies, and they decide whether to reimburse as “medically necessary” (or some similar definition) any type of medical care that comes into question. They’re an unfortunate necessary
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
This post is from the non-Reed Smith side of the blog.
We’ve posted on two other occasions about the Shuker v. Smith & Nephew case as the Eastern District of Pennsylvania systematically dismantled the case on the grounds of preemption and pleading deficiencies. You can find those posts here and here. Unfortunately, the recent