Friction between the First Amendment and the FDA’s attempts to regulate off-label drug promotion has existed for decades. It has sparked an ever growing body of case law that often finds the FDA overreaching. One of the more recent examples is the Second Circuit’s decision in Caronia, which vacated a criminal conviction that had
We’ve blogged several times about the FDA’s pending proposal to gut preemption with respect to generic drugs, and that proposal’s numerous flaws. We have been remiss, however, in not mentioning the industry’s 2014 counter-proposal that’s was jointly proposed by GPhA (for the generic industry) and PhRMA (for the branded/innovator drug manufacturers). Given how intensely the generic and branded wings of the pharmaceutical industry compete with (and sue) one another, that they could join together in opposition to the FDA’s proposal says something in and of itself like how bad the FDA’s proposal really is.
Anyway, to start, here is a link to the joint GPhA/PhARMA letter that details the industry’s solution to the problem of label-update delay in general. That’s the key. The industry proposal ends the disparity (identified by the Supreme Court in Mensing, among other places) between how the FDA treats generic and branded/innovator drugs. The industry proposal thus stands in stark contrast to the FDA’s, which would both perpetuate and worsen the divergence between the processes affecting the two types of prescription drug manufacturers.Continue Reading The FDA Gets an EARful on Label Changes
A little like one of those peanut-shaped asteroids, today’s post cobbles together a couple of recent developments that, other than having relevance to the FDA, do not have all that much in common.
The first deals with a recent Supreme Court decision that doesn’t even have anything to do (directly) with the FDA. In Perez v. Mortgage Bankers Ass’n, No. 13-1041, slip op. (U.S. March 9 2015), the Court overturned a D.C. Circuit gloss on the Administrative Procedures Act that purported to require administrative agencies generally (which is where the FDA comes in) to go through notice and comment rulemaking whenever they flip-flop on what is a mere “interpretive” rule. The Court shot that down, giving a significant win to the government. Slip op. at 9 (“In the end, Congress decided to adopt standards that permit agencies to promulgate freely such rules − whether or not they are consistent with earlier interpretations.”).
In the short term, that means that the FDA can change its interpretive rules – those that, like Guidance Documents, do not purport to have force of law – essentially when and how it likes (not exactly, but close enough for non-government work).Continue Reading Can The FDA Do That?
In a Federal Register Notice (link here) the FDA formally announced today that it’s revisiting its pending proposal to kill generic preemption. The comment period has been reopened and will extend until April 27, 2015. In addition, there will be a webcast “public meeting” on the proposal on March 27, 2015. Details as
On December 18, the FDA published its proposed rule for replacing the venerable package insert with “electronic” prescribing information. The cite is 79 Fed. Reg. 75506, and a link to it is here. We’re not regulatory lawyers, so we’ll leave any debate over whether this proposed rule is good or bad to the folks at the FDA Law Blog.
We’re product liability litigators, so when we hear about “electronic” anything, one thing we think about is ediscovery. Currently, with paper package inserts, when we’re taking discovery, all we have is the prescriber’s say so about whether s/he reviewed the insert, and when. Nor do we have any sure way of knowing exactly what version of drug/device labeling the prescriber reviewed. The date of the visit that produced the prescription, when placed against the history of the relevant labeling provides a pretty good idea, but there’s always a chance that the product sat on a shelf somewhere through a label change or two.
If the FDA’s proposal to shift to electronic distribution of the prescribing information that’s now in package inserts takes effect all that could change. The main avenue of distribution envisioned by the FDA would be a “single, comprehensive Web site” − an online “repository” operated by the FDA itself:
The proposed rule would require manufacturers and applicants to distribute electronically prescribing information by submitting the labeling in an electronic format that FDA can process, review, and archive . . . to FDA each time the labeling content is changed. The submitted labeling would be distributed via FDA’s labeling repository Web site (labels.fda.gov), which is a publicly available Web site.Continue Reading Has the FDA Created Another Ediscovery Front?
Try as it might, the FDA just can’t seem to articulate sound regulatory policy relating to “promotion” (which still isn’t defined in any regulation) without running headlong into the wall of the First Amendment. Recently, the FDA released, “for comment purposes only” two draft guidances relating to promotion on the internet. One of them is called “Guidance for Industry − Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.” You can read that one here. The other one, entitled “Guidance for Industry − Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” can be accessed here.
Both draft guidances seek to regulate what regulated manufacturers can do to “promote” their products on their own websites. Okay, we have no inherent problem with the Agency doing that. FDA-regulated manufacturers are, after all, FDA regulated.
Unfortunately, the FDA never seems to be satisfied with regulating only those it is empowered to regulate. Its bureaucratic empire builders always seem to overreach. In these draft guidances, they do so by laying claim to authority over non-manufacturer websites that regulated manufacturers “influence.” For example, in Interactive Promotional Media DG declares: “A firm is responsible for product promotional communications on sites that are . . . influenced . . . by . . . the firm.” Id. at 3. What does “influence” mean? It’s hard to say because the FDA’s discussion is somewhat tautological, but here is the Agency’s “guidance” on that point:
In determining whether a firm must submit promotional material about its product(s) to FDA, the Agency considers whether the firm . . . is influencing . . . the promotional activity or communication in whole or part. Thus, a firm is responsible if it exerts influence over a site in any particular, even if the influence is limited in scope. For example, if the firm . . . has editorial, preview, or review privilege over the content provided, then it is responsible for that content.
Id. at 4. Thus, “regardless of financial support, if a firm has any . . . influence on, the third-party site, even if limited in scope, it is responsible for submission to FDA to meet the postmarketing submission requirements.” Id.Continue Reading Social Media – Now The FDA Wants To Regulate . . . Us?
This post is from the non-Reed Smith side of the blog.
We’ve reported on multiple sets of in limine and summary judgment rulings coming out of the Pelvic Mesh MDLs (see here, here, here and here for example). And there is a new batch just in. Like the other rulings coming out of this litigation, they are a mixed bag. As is our usual procedure, we are going to primarily focus on the positive and we’ll skip over a lot of the redundant and more mundane rulings. It should make for a short, but hopefully informative post.
All of the rulings were entered in Bellew v. Ethicon, Inc., No. 2:13-cv-22473 (S.D. W. Va.), a bellwether case in the Ethicon Pelvic Mesh MDL. We’ll start with the in limine rulings which can be found at Bellew, 2014 U.S. Dist. LEXIS 165709. Many of the motions were standard – by defendant to exclude evidence of other allegedly bad acts (denied without prejudice); by plaintiff to exclude evidence of other allegedly good acts (denied in part (granted only as to things defendant agreed they would not introduce at trial)); by defendant to exclude that it no longer sells the product at issue (granted); by plaintiff to exclude evidence of 510k clearance (granted).
There was one motion in limine, however, that caught our attention as one we see more commonly brought by defendants. Although, this issue can cut both ways, so we aren’t going to offer much commentary here. Plaintiff moved to exclude “opinion testimony from treating physicians.” Id. at *24. The reason this is more often a defense motion is the unlevel playing field we’ve railed against for years. Plaintiffs have unfettered, ex parte access to the treaters. So, they often use that time to show the doctor things like medical literature the doctor had never read, corporate documents the doctor would never have otherwise seen, or information that post-dates the doctor’s treatment of the plaintiff. All of this is done in an attempt to secure opinion testimony on causation. Now, if the treater is retained by plaintiff as an expert and prepares an expert report, his opinions, like those of any other properly disclosed expert, are scrutinized under Daubert. The problem comes when plaintiff tries to proffer the causation opinion without the expert report.Continue Reading A Collection of Ethicon Mesh Rulings
Today’s post is really three different posts on three unrelated subjects. None of them very long (at least by DDLaw Blog standards), but we think that each will be of interest to at least some our readers.
On Generic Plaintiffs’ Preemption “Win” in New Jersey
This piece is from the non-Dechert side of the blog.
Plaintiffs alleging failure to warn of the risks of a generic drug scored a “win” of sorts in In re Reglan Litigation, 2014 WL 5840281 (N.J. Super. App. Div. Nov. 12, 2014). The court held, in an unpublished decision, that “failure-to-update” claims survived the otherwise comprehensive impossibility preemption that applies to generic drugs:
[T]he trial court correctly determined that plaintiffs’ claims based on the Generic Defendants’ failure to update their warnings to conform to changes made to the brand-name warnings are not preempted by federal law. The court correctly found that allowing plaintiffs to assert these claims would not frustrate any of the purposes or objectives that Congress sought to achieve . . . . Moreover, plaintiffs are not pursuing state-law claims based on an alleged violation of federal law.
Id. at *4. As the Appellate Division points out, non-preemption of “duty to update” is the majority view.
We may not like it, but we’re not losing much sleep about it.
We just read with interest the recent DC Court of Appeals decision in Ivy Sports Medicine, LLC v. Burwell, ___ F.3d ___, 2014 WL 4801283 (D.C. Cir. Sept. 26, 2014). In Ivy Sports, the FDA drew back a nub when it argued that it had “inherent authority,” beyond that granted by statute (specifically 21 U.S.C. §360c(e)) to change the classification of a medical device. The court of appeals held that, where the statute mandated procedures that the FDA had to follow in revisiting a previously-adopted device classification, the FDA couldn’t ignore those procedures by asserting unbounded “inherent” power to do what the statute governed. In the words of the court:
Continue Reading Another Preemption Thought
Our first post of the fall (and new year, according the Hebrew calendar), concerns something we do not usually post about – the adequacy of allegations in a criminal indictment. Much like we feel about seasonal changes, we have mixed views about the opinion in United States v. Kaplan, No. 2:13-CR-00377-PMP-CWH, 2014 U.S. Dist.