It’s a unique relationship based largely on knowledge and trust. Doctor’s not only have to rely on their medical knowledge, but they need to apply that to their knowledge of the patient. Knowledge that often develops overtime through trust. Patients want and need to be able to trust their doctors. Sometimes patients share information with
Can a court decision be simultaneously depressing and exhilarating? You might be surprised how often that happens. In United States v. Facteau, 2020 WL 5517573, (D. Mass. Sept. 14, 2020), the court upheld criminalization of off-label promotion, but did so in a way that might signal the end of an era in which pharmaceutical
Some of us belong to the Food and Drug Law Institute. One benefit of FDLI membership is a daily newsletter on FDA-related issues. The other day that newsletter’s top two links were both COVID-19 related – and we found both of them concerning.
The first item the newsletter featured was this story on “The
We’ve been watching the evolution of the Supreme Court’s thinking on First Amendment review of “speaker” and “content” specific prior restraints since we first noticed that emerging doctrine in the pharmaceutical detailing case, Sorrell v. IMS Health, Inc., 564 U.S. 552 (2011). In Sorrell, however, it was unclear how much (if any) more
Not too long ago we commented on the President of the United States promoting the unproven off-label use of a prescription drug, hydroxychloroquine, for treatment of COVID-19, on nationwide TV, in the presence of the Commissioner of the FDA, no less. As we pointed out in the prior post, this drug has serious potential side
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