If we had forgotten that there continue to be abundant U.S. cases of COVID-19, then there was plenty around us to remind us. Public mask usage seems to have increased. We heard how the “tripledemic” of viruses had made hospital beds scarce. We have had colleagues out of commission instead of completing our assignments. The
Pacira Biosciences, Inc. v. American Society of Anesthesiologists, Inc., 2022 WL 336585 (D. N.J. Feb. 4, 2022), is not a product liability opinion. Instead, it occurs in the context of a motion to dismiss a trade libel case brought by a pharmaceutical company. The Pacira court decided that the truth/falsity of scientific ideas published
We told you that if anti-vaxxers found a sympathetic court in their quest to declare government vaccine mandates unconstitutional, we would let you know. Well, we did not think it would be so soon. And we surely did not think that the sympathetic court would be the United States Supreme Court.
Don’t get the wrong
This post is about a hidden gem. That brings to mind a hiking trail that’s one of the two best in Pennsylvania (along with Ricketts Glen), but isn’t found in any of the “Fifty Hikes in [fill in the blank]” books that one finds in outdoorsy stores. The hike is part of the Appalachian
There’s a problem with attorney advertising in the prescription medical product space – but it’s not the one you normally hear us defense-side litigators kvetching about. Quite apart from its litigation-generating effects, attorney advertising can have adverse public health consequences when all the anti-pharma hyperbole causes patients to cease taking targeted products in violation of
More than once we’ve said that we read law review articles so you don’t have to. We separate the wheat from the chaff. The wheat is scarce. That is because law review articles usually drown the little bits of objective description of what the cases DO say with enormous chunks of pie-in-the-sky suggestions of what
Last week we bashed a Ninth Circuit Daubert decision. We feel a little bit bad about that, not because the decision wasn’t bashworthy – no, Wendell really is a rotten precedent – but because we hate contributing to the chorus of defense hacks who bemoan the Ninth Circuit’s supposedly liberal, pro-plaintiff bias. You see, we
Now that Dr. Scott Gottlieb is safely installed as FDA Commissioner, we at DDLaw can end our moratorium on blogposts about First Amendment issues. There was no way we wanted to give his opponents any ammunition by saying nice things about Dr. Gottlieb before his confirmation.
Not so now.
Given what Dr. Gottlieb has said
This guest post is from Liz Minerd, an associate at Reed Smith. She previously wrote the post on the FDA’s off-label promotion meeting last November, so when she indicated that she’d like to write about the FDA’s “Midnight Memo” on the same topic, we were only too happy to say “yes.” So here is some in-depth analysis of the FDA’s rather unusual decision to, in effect, comment on its own meeting. As always, our guest posters deserve all the credit, and any blame, for their efforts.
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As this blog reported here, last week—two days before the change in administrations—the FDA released a memorandum entitled “Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products” available here. The Agency characterizes this 12th hour memorandum as a follow up to the two-day public meeting it held on November 9-10 regarding off-label promotion (or what the Agency refers to as “communications regarding unapproved uses of approved/cleared medical products”). In particular, the Agency claims that it is issuing this memorandum to provide “additional background” in response to frustrations expressed by certain speakers during the November meeting regarding the Agency’s failure to adequately address the First Amendment in the public hearing notice.
However, the real purpose of the memorandum appears to be to set forth the Agency’s justification for their current restrictions on off-label promotion before a new administration and a new FDA commissioner could have a chance to revisit them. Indeed, after briefly noting the First Amendment concerns raised at the November meeting, the Agency spends the first twenty pages of the memorandum detailing its oft-repeated policy justifications for its current restrictions before addressing any of the First Amendment jurisprudence that has called those restrictions into question. Its attitude is reflected in the memorandum’s first case citation—to the dissent in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012). [Memorandum, at p. 2. fn. 3] The Agency’s lengthy policy discussion demonstrates that the outgoing policymakers at the FDA find very little benefit in communications from manufacturers regarding off-label uses even, though it recites that off-label uses can be the standard of care in some circumstances. This attitude, that only the Agency can keep the public sufficiently safe, is classic governmental paternalism of the sort that the United States Supreme Court has repeatedly condemned in its First Amendment decisions over the past several decades.
For example, the Agency asserts that it seeks to “motivate” the creation of “robust scientific data” about the safety and effectiveness of drugs. [Memorandum at 4-5] However, the current prohibitions only do so prior to approval of a product. After approval—a time period usually much longer than the approval process itself—the current prohibitions prevent the same manufacturers from providing the same sorts of scientific data to the same audience. Thus, the Agency’s current prohibitions actually interfere with the continued creation of robust scientific data after approval. For example, a manufacturer can be required to post clinical trial results concerning an off-label use [Memorandum at 17-18], but is prohibited from informing doctors that they can view the results on ClinicalTrials.gov and decide whether their patients might benefit from the studied use.
We haven’t digested it yet, so this isn’t a substantive post, but we wanted to make our readers aware that today the FDA made an announcement, which states in pertinent part:
We have also added a document to the docket for the public hearing titled “Memorandum: Public Health Interests and First Amendment Considerations Related