We were recently asked the question, “are failure to contraindicate claims preempted?”  Our immediate response was, “How could they not be”?  However, it’s not helpful to answer a question with a question, and as with all things preemption, matters are not as simple as they might seem.  Therefore, we thought we’d explore this issue in more depth.

We discussed failure to contraindicate claims several times in the run-up to Wyeth v. Levine, 555 U.S. 555 (2009).  We believed – and still do – that Levine was tried to the jury on a claim that the defendant should have contraindicated the particular use of the drug involved in that case.  It didn’t ultimately turn out that way.  Rather, in Levine, the Supreme Court went through contortions specifically to avoid having to decide a “failure to contraindicate” claim:

[Plaintiff] also offered evidence that the [FDA-approved use] should be contraindicated and that [the drug] should never be administered [that way]. Perhaps for this reason, the dissent incorrectly assumes that the state-law duty at issue is the duty to contraindicate. . . .  But, as the Vermont Supreme Court explained, the jury verdict . . . did not mandate a particular replacement warning, nor did it require contraindicating [the use]. . . .  We therefore need not decide whether a state rule proscribing [the FDA-approved use] would be pre-empted.

555 U.S. at 564-65. Heck, even the plaintiffs’ counsel in Levine conceded that a failure-to-contraindicate “would be preempted” where the FDA “concluded that it should not be” contraindicated.  Levine argument transcript at 32-33; see id. at 39-40.

Levine thus did not allow failure to contraindicate claims – rather it changed the facts of the case to avoid doing that, while still reaching an anti-preemption result.  Pretty obviously, the anti-preemption justices in Levine could not muster a majority that would permit state tort law claims that sought to ban FDA-approved uses.  Compare the result in Levine to the extensive preemption recognized in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), where the Court did recognize the presence of a contraindicated use.  Id. at 320 (device used in a patient’s “heavily calcified” arteries; “the device’s labeling stated that use was contraindicated for patients with diffuse or calcified stenosis”).  Among Riegel’s preemption holdings was that the plaintiff’s warning claims were preempted.  Id. at 329 (holding “the MDA would pre-empt a jury determination that the FDA-approved labeling for [the device] violated a state common-law requirement for additional warnings”).

The regulatory background for a contraindication is much more stringent than for warnings and other types of labeling. The FDA’s strict prerequisites for contraindications are at 21 C.F.R. §201.57(d). That regulation requires:  (1) a contraindication must relate to a “known hazard” and (2) due to that hazard “the risk of use clearly outweighs any possible benefit.”

Further reflecting that stringency, while the FDA’s changes-being-effected (“CBE”) regulation used to include “contraindications” broadly as something subject to unilateral modification, that’s no longer so.  As discussed in excruciating detail below, the FDA amended the relevant regulation in 2006, and now most contraindications in fact are subject to an express exception in the CBE regulation that requires prior FDA approval.  Thus, the CBE regulation should no longer an obstacle to finding failure to contraindicate claims preempted.  For almost every prescription drug that hasn’t gone generic, arguing that failure to contraindicate claims aren’t preempted on the basis of the CBE regulation is simply bogus, since that regulation is inapplicable.

A failure to contraindicate claim is inherently in conflict with FDA regulatory authority, since it would allow liability based on the defendant’s failure to contraindicate a use that the FDA had looked at and said was okay. Once the FDA says “you can do X,” that regulatory result is in absolute conflict with a state-law cause of action predicated on a theory that “you can’t do X.”  This kind of state-law infringement on FDA powers has been preempted under the FDCA for over 100 years.  See McDermott v. Wisconsin, 228 U.S. 115, 137 (1913) (finding conflict preemption where state law “forb[ade] all labels other than the one it prescribed,” including the FDA-approved label).

So this direct conflict is one preemption argument that applies against a failure to contraindicate claim.  The FDA approves/clears drugs and medical devices for each “intended use.”  21 C.F.R. §§201.128, 801.4804.1.  A failure to contraindicate claim seeks to prohibit an FDA-allowed intended use.  Thus, such claims are really a species of  “stop selling” claim of the sort that the Supreme Court held were impliedly preempted in Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013):

The Court of Appeals reasoned that [defendant] could escape the impossibility of complying with both its federal- and state-law duties by “choos[ing] not to make [sulindac] at all.” We reject this “stop-selling” rationale as incompatible with our pre-emption jurisprudence. Our pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability.  Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be all but meaningless.

Id. at 2477 (citations and quotation marks omitted).  Courts have recognized that disguised stop-selling claims are likewise preempted under Bartlett.  Thus, as we discussed here, in Yates v. Ortho-McNeil Pharmaceuticals, Inc., 808 F.3d 281, 300 (6th Cir. 2015); Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2016 WL 7429449, at *11 (S.D.N.Y. Dec. 23, 2016); and Brazil v. Janssen Research & Development LLC, 196 F. Supp.3d 1351, 1364 (N.D. Ga. 2016), never-start selling claims based on allegations that the defendant should never have submitted the product to the FDA were all held preempted as “stop-selling” claims.

Failure to contraindicate allegations satisfy our rule of thumb for identifying disguised stop-selling claims.  We look at the learned intermediary rule and causation.  Would the claim in question allow the plaintiff to argue that the actions of the “learned intermediary” – the prescribing physician/treating surgeon – are irrelevant to a causation determination because the physician should never have been allowed to prescribe/use the product on the plaintiff in the first place?  If yes, then the claim is a disguised, and preempted, stop-selling claim.  The fraud-on-the-FDA claims in Buckman, the stop-selling claims in Bartlett, the Yates claims that a different design should have been submitted to the FDA in the first place all share this characteristic, as do failure to contraindicate claims.

This is our preferred route to preemption of failure-to-contraindicate claims.  There is simply an inherent conflict between the FDA’s regulatory authority to decide what products/”intended uses” are able to be marketed in the United States and state-law claims that would allow liability for failure to contraindicate a use that the FDA has approved.

There is also a more technical preemption argument – alluded to earlier, when we mentioned the CBE regulation − at least with respect to prescription drugs and biologicals.  As discussed in Levine, 555 U.S. at 568-72, PLIVA, Inc. v. Mensing, 564 U.S. 604, 614-15 (2011), and by us here, the key to implied preemption is what we call the “independence principle.”  As concisely stated in Mensing:

[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.

564 U.S. at 623-24. The branded manufacturer in Levine, but not the generic manufacturer in Mensing, could have revised aspects of its label independently – however temporarily − by using the the FDA’s“changes-being-effected” (“CBE”) process.  Back when plaintiffs in Mensing and Levine alleged that labels should be modified, “[t]he CBE process permit[ted] drug manufacturers to ‘add or strengthen a contraindication, warning, [or] precaution.’”  Mensing, at 614 (citing 21 C.F.R. §314.70(c)(6)(iii)(A) (2006)).

However, neither Levine (2000 injury) nor Mensing (2001 & 2002 injuries) interpreted the current version of the FDA’s CBE regulation.  Effective June 30, 2006 – that regulation was amended by the Physician Labeling Rule (“PLR”) so that 21 C.F.R. §314.70(c)(6)(iii) now reads:

Changes in the labeling, except for changes to the information required in §201.57(a) of this chapter (which must be made pursuant to paragraph (b)(2)(v)(C) of this section), to accomplish any of the following:

FDA, “Requirements on Content and Format of Labeling for Human Prescription Drug & Biological Products, 71 Fed. Reg. 3922, 3997 (Jan. 26, 2006) (reflecting amended language) (emphasis added).  See id. at 3922 (stating effective date).  Exactly this language is in the current version of 21 C.F.R. §314.70(c)(6)(iii) in the United States Code.

That means that the broad applicability of the CBE regulation to “contraindications” alluded to in Mensing and Levine no longer exists.

Since the mid-2006 PLR revision, there has been an express exception to the CBE rule for “changes to information required in” 21 C.F.R. §201.57(a), which is the regulation that requires inclusion of a “Highlights” section to prescription drug labeling.  No “Highlights” section even existed under the format for prescription drug labeling that governed the period of time at issue in Levine or Mensing.

Changes to Highlights information thus cannot be made unilaterally under the CBE regulation.  Rather 21 C.F.R. §314.70(b)(2)(v)(C) applies.  That section concerns “major changes” for which “[a] supplement must be submitted” to the FDA.  Id. §§314.70(b), 314.70(b)(1).  As one might expect, all drug “contraindications” must be included in the Highlights section:

Highlights of prescribing information.  The following information must appear in all prescription drug labeling: . . . (9) Contraindications.  A concise statement of each of the product’s contraindications. . . .

21 C.F.R. §201.57(a)(9) (emphasis added).  Highlights must now be included for any prescription drug approved by the FDA after June 30, 2001.  See 21 C.F.R. §201.56(c) (setting out staggered compliance schedule, completed in 2013, for drugs approved between that date and June 30, 2006, when all new drug applications must contain labeling highlights).

Thus, while the old CBE regulation, considered by the Supreme Court in Levine and Mensing, included “contraindications” generally as types of warnings that could be modified/strengthened unilaterally, now contraindications (and anything else that must be included in PLR Highlights) may not be unilaterally added to the labeling for any drug approved after June 30, 2001.  The Highlights need not present all “Warnings” and “Precautions” contained in the labeling − only a “concise summary of the most clinically significant” safety concerns is required.  21 C.F.R. §201.57(a)(10).  Contraindications, however, are different.  Section 201.57(a)(9) mandates that “each” contraindication be included in the Highlights section for drug labeling.  CFR § 201.57(c)(6).

The FDA discussed the Highlights section and the CBE process further in a 2013 guidance document:

Changes to Highlights through a CBE supplement:  With minor exceptions, changes to Highlights require a prior approval supplement (§§314.70 and 601.12).  If the labeling is already approved in the PLR format and the proposed change(s) qualify for a CBE supplement under §§314.70(c) and 601.12(f), a prior approval supplement is not needed as long as the change does not warrant inclusion in Highlights (e.g., addition of an adverse reaction to the ADVERSE REACTIONS section in the FPI).  If, in the opinion of the applicant, the new information warrants inclusion in Highlights or will be listed under Recent Major Changes in Highlights (i.e., a change to the BOXED WARNING, CONTRAINDICATIONS, OR WARNINGS AND PRECAUTIONS sections), the applicant should notify the appropriate review division about the proposed change to the labeling.  The review division may permit changes to Highlights through a CBE supplement after consideration of the new information.

FDA, Guidance for Industry, Labeling for Human Prescription Drug & Biological Products − Implementing the PLR Content & Format Requirements, 2013 WL 10904638, at *21 (Feb. 2013) (emphasis added).

Putting all this regulatory material together in more easily comprehensible form, the upshot is that failure to contraindicate claims should now be preempted by reason of impossibility under the Mensing/Bartlett “independence principle” for any prescription drug (or biological) approved by the FDA since mid-2001.  Since all contraindications must be included in Highlights, and all changes to Highlights require prior FDA review and approval – either through a Prior Approval Supplement (“PAS”) or, as noted in the above FDA PLR Guidance, through a CBE supplement “after” FDA has consider the new information and permitted the change through a CBE supplement – contraindications can no longer be changed unilaterally via the CBE process.

So far, Highlights haven’t received a lot of attention in preemption cases.  We recently discussed the first case we found on this point, Blackburn v. Shire US, Inc., 2017 WL 1833524 (N.D. Ala. May 8, 2017), which did not involve any allegations concerning contraindications. Blackburn held:

[I]n almost all instances, any change to the Highlights section of an approved drug’s label requires FDA approval. Again, in circumstances such as these, a private party’s claim is only preempted if the drug manufacturer was not able to act independently under federal law to do what state law requires.  That is, preemption exists “when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance.”  [Mensing], 564 U.S. at 623-24.  Such assistance “is dependent on the exercise of judgment by a federal agency,” and as such “that party cannot independently satisfy those state duties for preemption purposes.”  Id. at 624.  Accordingly, when sufficient newly acquired information exists in order to support a label change under the CBE process, as has been plausibly pled here, the claim is not preempted.

However, the same cannot be said with respect to Plaintiff’s assertion that a change to the Highlights section would be permitted here.  Where a private party seeks a label change which requires FDA approval, such as a change to the Highlights section, impossibility preemption exists. . . .  The “impossibility” inquiry turns on a private party’s ability to act independently.  It is of no consequence that the FDA may have allowed a change to the Highlights section of [the drug].  Because Defendants could not have independently changed the Highlights section of [the drug] in order to conform to state law, any argument that begins with the theory that Defendants could (or should) have changed the Highlights section of [the drug’s] label ends in preemption.

Id. at *5-6 (emphasis added).  The court rejected the plaintiff’s attempt to avoid preemption of changes to Highlights by arguing that the defendant could have “sought expedited FDA approval of the Highlights section change or asked the FDA to waive such an approval requirement by submitting a written waiver request to the FDA.” Id. at *6.  The availability of these options doesn’t matter for preemption purposes, since neither allows the defendant to make a change to its label independently, which is what is necessary to avoid preemption under Levine, Mensing, and Bartlett.

Finally, turning away from legal issues, contraindications also work differently in medical practice, where physicians often view them as outright bans.  E.g.Rader v. Smithkline Beecham Corp., 2017 WL 524925, at *5 (Pa. C.P. Feb. 7, 2017) (prescriber testified “if it’s contraindicated, we wouldn’t prescribe it under any circumstances”).  For a physician to proceed in the face of a labeled contraindication invites malpractice claims, perhaps even punitive damages, if anything goes wrong.  Contraindications thus tend to replace, rather than supplement, the usual physician balancing of risks and benefits.

Were juries allowed to impose contraindications that do not meet the FDA’s strict standards, patients and physicians would be deprived of drug and device uses in situations where, from the agency’s perspective, risk does not outweigh benefit.  The dynamics of mass tort litigation only exacerbate matters as a jury-imposed contraindication-based verdict in one state becomes precedent seeking the same effective ban nationwide – particularly as the FDA does not allow product labeling to vary by state.  Thus, particularly pro-plaintiff juries in certain locales would impose Gresham’s Law – with bad common-law decisions driving out what the FDA and the medical profession otherwise view as proper medical practice.  Patients who would benefit from tort-contraindicated uses lose those benefits, even where data reviewed by the FDA show benefits exceeding harm.  That would be the practical effect of allowing plaintiffs to bring, and common-law juries to decide, failure to contraindicate claims.

Thus, not only are failure to contraindicate claims preempted under the rationales discussed above, but as a matter of public policy, such claims should not be recognized in the first place.

 

Parties often file motions in limine on fairly case-specific issues, building on the history of discovery and motions practice in the case.  Applying a ruling on in limines from one case to another can be a dicey proposition as potentially significant differences in the facts, law, claims and defenses asserted, and other rulings can usually be identified.  Plus, many pre-trial decisions on evidence do not last once doors get opening and evidence can be cumulative, among other reasons why judges’ minds change.  Still, we do posts on rulings on motions in limine that we guess might have some relevance to other cases our readers have.  When we do, we can be hamstrung by the limited information in these opinions on the facts, allegations, and other rulings, such as rulings on motions for summary judgment that would typically be rendered before the in limines are decided.

In In re Depakote, No. 15-CV-702-NJR-SCW, 2017 WL 2126837, *2 (S.D. Ill. May 16, 2017), we have rulings on a grab bag of motions in limine after the court issued partial summary judgment for the drug manufacturing defendant based on “preemption of label changes related to development delay” after fetal exposure of the medication.  If this summary judgment ruling sounds familiar, then you might need a hobby.  You also might have read any number of our posts on the Rheinfrank case and the ultimate affirmance of its preemption decision and defense verdict by the Sixth Circuit.  Like here, here and here.  As we said of the appellate decision, “The court held, ‘[g]iven, then, that as of 2008 the FDA did not believe the state of the data supported a developmental delay warning, it stands to reason that as of 2003, with even less data to go on, the FDA would similarly have rejected a developmental delay warning.’ Thus, Rheinfrank joins those courts that have drawn a preemptive line barring all plaintiffs who used a drug prior to an FDA insufficient evidence decision concerning the risk at issue.”  We also wondered how the case got to a jury given trial court’s preemption decision and the requirements of Ohio law.  We have similar wonderment at the instant case, which involved 2006 fetal exposure.  The decision is sparse on facts, but it is hard to imagine a viable product liability claim for the plaintiff’s injury when plaintiff cannot prove that the label in place when the drug was prescribed to the mother should have said something different about the risk of the injury in question.  Some sort of warnings claim seems to be pending, along with a claim for punitive damages.

With that background, we turn to the subset of the 28 total motions in limine that we think matter most.  First, consistent with the preemption ruling and the applicable regulation, plaintiff could not preclude the manufacturer from explaining that a proposed change to the label through the CBE regulation is still subject to FDA’s decision to accept, reject, or modify the proposed change.  2017 WL 2126837, *2.  What the CBE regulation has to do with plaintiff’s surviving warnings claim or whether it could have used (e.g., based on new evidence of safety) is unclear. Second, plaintiff’s red herring argument about whether FDA is required to do its own post-marketing studies did not preclude the defendant from presenting evidence that it followed labeling regulations.  Third, while the court allowed some speculative evidence from the plaintiff’s mother in connection with the inquiry on proximate cause for failure to warn—which should not happen unless a different developmental delay warning has been articulated—this opened the door to some amount of evidence on what she knew and how she behaved. Id. at **2-3.

As to the defendant’s motions, the post-conception labeling and regulatory communications were excluded and defendant agreed not to raise pre-conception discussions with FDA about labeling changes that were not yet approved. Id. at *3.  (With the limited information presented in the opinion, we cannot say if there was evidence that FDA rejected or discouraged whatever labeling change plaintiff was allowed to urge in the case.)  The court also excluded a 2009 FDA alert about the risk of birth defects with the drug, although plaintiff was allowed to discuss any pre-conception studies that went into the alert. Id. at *4.  Limiting warnings evidence to what existed before the prescription at issue makes sense, but it also makes sense that there needs to be a claim based on what the warnings should have said instead at that point.  Along those lines, plaintiff was not allowed to argue that the drug should have been contraindicated for use in pregnancy because plaintiff offered no expert who disclosed such an opinion. Id. (And such an opinion would have had some preemption problems, we think.)  Plaintiff was allowed, however, to offer evidence about foreign labels for the drug in place before plaintiff’s conception, holding that the manufacturer’s knowledge of these labels was relevant to its duty to warn. Id. at **7-8.  Breaking somewhat from its previously firm line on the irrelevance of the post-conception evidence to the warnings claim, the court did not foreclose the possibility that some post-conception marketing materials could be relevant if “they contain pre-2006 facts.” Id. at *6.  Again, we would think the pre-2006 facts would need to relate to whatever about the 2006 warnings for developmental delay that plaintiff was allowed to claim should have been different.

There was one last ruling that bears some discussion.  The defendant had pleaded guilty to a misdemeanor and paid a very, very large fine related to allegations of off-label promotion for use of the drug for schizophrenia and elderly dementia, which were not labeled indications. Id. at *9.  The plaintiff’s mother did not use the drug for these conditions and there was no evidence to “connect these activities with the 2006 Depakote teratogenicity warning.” Id. So, there was far too much prejudice compared to the probative value to let the jury hear about the plea or fines.  However, plaintiff was allowed to “introduce evidence regarding the off-label marketing and sales efforts . . . regarding bipolar disorder,” which was an indication added during 2006 (based on our quick look). Id.  The court saw this evidence as supporting plaintiff’s claim for punitive damages.  It seems to us that a plaintiff’s punitive damages evidence is not relevant unless it tends to show that the underlying conduct giving rise to liability was done with the requisite intent.  It does not sound like there is any connection between an alleged, non-preempted issue with the 2006 warnings for developmental delay and any off-label promotion issue, but maybe that link was just not spelled out in the opinion.

 

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 – and is saying – we doubt that the FDA’s absolutist ban on truthful industry speech about off-label uses (pejoratively called “promotion”) will continue much longer in its current form.  For instance, on the FDA’s website, Dr. Gottlieb is quoted here as giving a speech saying:

The question we need to ask ourselves is this: Should a patient receive one or even two-year-old care just because the wheels of my government institution and its meticulous work may take longer to turn than the wheels of clinical science?  Some people believe that patients should be treated only according to the clinical evidence included in a drug’s approved indications.  Yet this evidence may be two or maybe three years old, especially in a fast-changing field like cancer, where off label use of medicines provide important opportunities for patients to get access to the latest clinical practice and for doctors to tailor their patients’ treatment plans based on medical need and personal preferences.

*          *          *          *

Efforts to limit prescription and scientific exchange to indications only specified on a label could retard the most important advances in 21st century medicine.  The development and deployment of drugs is becoming more and more closely linked to understanding of mechanism of action, which means that physicians can use drugs in more sophisticated ways that cannot all be anticipated on a label, or easily or quickly studied in prospective studies. . . .  More important, medicine is becoming more personalized as tools like genomics make it possible to tailor treatments on an individual basis. Physicians will not be able to always wait for FDA to approve a new label for every one of their patients, and drug companies will not be able to conduct a trial to explore every possible contingency.  In the future, personalization of care could mean that we will have much more off-label use of new medicines, guided by the latest literature, at least until our regulatory approaches are able to fully adapt to a different paradigm where treatment is highly specific to individual patients.  Yet policy forces are tugging in exactly the opposite direction by placing restrictions on the exchange of some of the most pertinent information.

(Emphasis added).  Defendants in cases involving off-label-use-related allegations should consider having their FDA experts review and, if appropriate, rely upon the current FDA Commissioner’s positions – particularly to rebut contrary views offered by former FDA officials.

Dr. Gottlieb’s non-FDA writings show similar solicitude for scientific speech – whether or not that speech originates with FDA-regulated manufacturers.  In an article for the American Enterprise Institute, Dr. Gottlieb criticized FDA policies that “prohibited” a manufacturer with a drug undergoing supplemental FDA approval for a new use from “distributing the findings or educating doctors on the new use through sponsored medical education.”  “[A] more measured approach to the regulation of promotion” would allow “sharing of useful information that falls within the bounds of appropriate clinical care.”

Those who pursue a rigid adherence to restrictions on the exchange of off-label information, and who fail to recognize that the sharing of scientific evidence can sometimes have important public health benefits, are guilty of pursuing a rigid standard that does not take measure of the consequences. . . .  [E]stablishing the FDA label as the only determinant for acceptable scientific speech loses sight of the fact that these labels are slow to incorporate important medical results about the effectiveness of medical products. They are not the sole basis for medical practice.

In another AEI article a few years later – shortly after the government lost United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) − Dr. Gottlieb’s criticism of the FDA’s prohibition of truthful speech about off-label uses was even more pointed.

When this [off-label] speech is truthful, nonmisleading, and promulgated in an educational context, it is quite possible that the speech would be deemed constitutionally protected by the courts under doctrines that recognize commercial speech as being subject to First Amendment considerations.

(Footnote omitted).  Basically, Dr. Gottlieb took issue with whether scientific speech concerning off-label uses could ever be considered illegal “promotion”:

A core principle of America’s constitutional speech protections is that the government should not establish what is orthodox, especially when it comes to politics, the arts, religion, and science.  The founders recognized that these matters are by their nature iterative, and that it would be dangerous in a democratic society for the government to use its resources to pick a side in these debates.  Matters that are subject to their own evolution − a core feature of how new science unfolds − are better addressed by adding voices to the debate, not suppressing them.

Dr. Gottlieb even urged FDA regulated manufacturers to stand up and challenge the constitutionality of off-label informational restrictions promulgated by the FDA – the agency he now leads:

[T]he drug industry needs to be willing to take the prerogative to challenge the facts in some of these cases and have that day in court. When investigations turn on the sharing of truthful, nonmisleading information about widely accepted uses of drugs, in fast moving fields like cancer, there is a legitimate question about whether public health is being served by suppressing this sort of information.  However, until these cases are challenged in court, there will remain ambiguity around where the appropriate lines rest, what speech is constitutionally protected commercial speech or clearly violative, and how public health is best served.

(Emphasis added).  Not long after that, a company took up Dr. Gottlieb’s challenge, and the result was Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015).

To some extent, where one stands depends upon where one sits, but Dr. Gottlieb has enough of a track record on truthful manufacturer speech about off-label uses of drugs and medical devices, and the constitutional and medical implications of suppressing it, that we are more hopeful now than we have ever been that the FDA will see reason, respect the First Amendment, trust physicians, and change its science-suppressing ways.

With that in mind, we examine the newest First Amendment precedent rejecting governmental prohibition of a manufacturer’s truthful speech about its product, Ocheesee Creamery LLC v. Putnam, 851 F.3d 1228 (11th Cir. 2017).  Ocheesee is a food (skim milk) case, but doesn’t involve the FDA – it doesn’t even involve the federal government.  Instead, Ocheesee is a demonstration that, when given the chance, state regulators are still equally capable of behaving just as badly towards the First Amendment as the feds, albeit on a smaller scale.

It may be that Ocheesee doesn’t involve interstate commerce, see 851 F.3d at 1231 n.1, or it may be that there is something peculiar about milk regulation that we don’t know, but the State of Florida (not the FDA or any other federal entity) came down on the plaintiff, described as “a small dairy creamery located on its owners’ farm” that “sells all-natural dairy items,” like a ton of bricks.  Id.  Apparently, the process of “skimming” the cream from whole milk “depletes almost all the vitamin A naturally present in whole milk because vitamin A is fat-soluble and is thus removed with the cream.”  Id.  Thus Florida agricultural regulations require vitamin A to be added to skim milk before it can be sold as “skim milk.” Id.

That was a problem for the plaintiff because, as a matter of philosophy, this business “prides itself on selling only all-natural, additive-free products.”  Id.  It therefore “refuse[d] to replace the lost vitamin A in its skim milk” with a vitamin A additive as Florida law required.  Id.  The State of Florida thus prevented the plaintiff from calling its product “skim milk,” even though that “product contains no ingredients other than skim milk.”  Id.  Instead (and ironically) the state sought to require the plaintiff to call its product “imitation milk.”  Id. at 1232.  Not surprisingly, the plaintiff refused and sued instead.

Readers attuned to the First Amendment no doubt see the problem already.  Calling such a product “skim milk” is truthful.  The State of Florida – like the FDA with truthful off-label speech – sought to suppress the plaintiff’s truthful speech in a commercial context, using the public health (vitamin A is not just good for you, but essential to health) as its reason for doing so.  Who wins – the First Amendment right to engage in truthful commercial speech, or the state’s public-health-based rationale for suppressing such speech?

In Ocheesee, freedom of speech prevailed.  851 F.3d at 1233 (“The sole issue on appeal is whether the State’s actions prohibiting . . . truthful use of the term ‘skim milk’ violate the First Amendment.  We hold that they do.”).

First, the lay of the constitutional land.  Ocheesee applied the now-venerable “Central Hudson” intermediate scrutiny test for constitutionality of governmental restrictions of commercial speech.  851 F.3d at 1233 (citing Central Hudson Gas & Electric Corp. v. Public Service Comm’n, 447 U.S. 557, 563-64 (1980)).  Thus, Ocheesee did not apply the more speech protective tests enunciated in Sorrell v. IMS Health Inc., 564 U.S. 552 (2011) (“heightened scrutiny”) (see our discussions here, here, here, and here); and Reed v. Town of Gilbert, 135 S.Ct. 2218 (2015) (“strict scrutiny”) (see our discussion here).  That doesn’t mean that the Eleventh Circuit was unaware of these cases – quite the contrary:

There is some question as to whether under the Supreme Court’s decisions in Sorrell and Reed an analysis to determine if the restriction is content based or speaker focused must precede any evaluation of the regulation based on traditional commercial speech jurisprudence, and if so, whether this would alter the Central Hudson framework.  In Sorrell, the Supreme Court found the restriction at issue to be content based but nevertheless cited, articulated, and applied the Central Hudson test.  And in Reed, the Court arguably broadened the test for determining whether a law is content based. . . .  We need not wade into these troubled waters, however, because the State cannot survive Central Hudson scrutiny, and in any event the [plaintiff] does not argue the State’s restriction was content based or speaker focused.

851 F.3d at 1235 n.7.  Thus, the favorable First Amendment decision in Ocheesee sets a floor for the protection of truthful commercial speech in the Eleventh Circuit that parties arguing Sorrell and Reed may exceed.

Under the Central Hudson criteria, as a “threshold question,” the government (which always has the burden of proof) had to establish that the suppressed speech either concerned “unlawful” conduct or was “false or inherently misleading.”  851 F.3d at 1235-36.  It failed because selling the plaintiff’s product was not unlawful – the state would have allowed its sale under the “imitation” description.  Id. at 1237.  Note the parallel to off-label speech – doctors are free to engage in off-label use, and products so used may be lawfully sold.  “[T]he only difference between the two courses of conduct is the speech.”  Id.

Nor could the speech be considered false or misleading.  The state could not simply “define” a product in whatever way it chose, and declare anything not meeting that definition “misleading.”  The court rejected such “self-evidently circular” reasoning:

Such a per se rule would eviscerate Central Hudson, rendering all but the threshold question superfluous.  All a state would need to do in order to regulate speech would be to redefine the pertinent language in accordance with its regulatory goals.

Id. at 1238.  Again, any resemblance to the FDA’s salami slicing of “intended uses” is entirely intentional.  Consumer “unfamiliarity is not synonymous with misinformation.”  Id. at 1239 (citation and quotation marks omitted).

Next up in Ocheesee was the three-pronged “intermediate scrutiny” Central Hudson test:  (1) was the asserted governmental interest substantial? (2) did the regulation directly advance the that substantial governmental interest? And (3) was the restriction on speech more extensive than is necessary to serve that interest?  851 F.3d at 1235-36.

As in off-label promotion cases, the “substantiality” of the government’s “interest in combating deception and in establishing nutritional” – that is to say product safety and effectiveness – “standards” was concededly “substantial.”  Id. at 1240.  Ocheesee jumped over the second prong and went right to the third, “because the measure is clearly more extensive than necessary to achieve its goals.”  Id.

In all commercial speech cases, “the preferred remedy is more disclosure, rather than less.”  Id. (Supreme Court citation omitted).  Florida’s flat ban on use of the term “skim milk” failed because a disclaimer would serve the same purpose in a “less restrictive” and “more precise” way.  Id.  “[A]llowing skim milk to be called what it is and merely requiring a disclosure that it lacks vitamin A” was sufficient “to serve [the state] interest in preventing deception and ensuring adequate nutritional standards.”  Id.

The First Amendment thus prevailed where the speech is truthful – without the court going even having to go to the trouble of relying on heightened (Sorrell) or strict (Reed) scrutiny, both of which would be argued in truthful off-label speech cases.  Visions of shattered backboards come to mind.  We don’t think Dr. Gottlieb wants the FDA to end up like Bill Robinzine, so we’re looking for a more reasonable off-label speech policy to emerge from the FDA, before a court has to do so for the agency.

Executions by lethal injection are in the news. Arkansas recently executed four inmates in just eight days. One of the drugs that it uses for its three-drug lethal injection protocol was set to move beyond its expiration date. And, apparently, Arkansas wanted to use them before that happened.  It seems that states are finding it more and more difficult to get the drugs that they need for lethal-injection executions.

In fact, Texas so badly needs to get access to one of those drugs that it is now suing the FDA to get it. The drug—thiopental sodium—is used to render inmates unconscious before the lethal drugs are administered. But Texas can’t get thiopental sodium anymore because the FDA, as of five years ago, bans its importation. It did so after a group of inmates successfully sued the FDA in federal court to stop it from allowing thiopental sodium into the country. The inmates claimed that thiopental sodium (i) was “misbranded” and (ii) an unapproved new drug. Interestingly, the FDA conceded both points. It argued that it could still allow thiopental sodium into the country, however, by exercising its enforcement discretion. The federal court disagreed. See Beaty v. FDA, 853 F. Supp. 2d 30 (D.D.C. 2012), aff’d in part, rev’d in part sub nom., Cook v. FDA, 733 F.2d 1 (D.C. Cir. 2013). The court held that the language of the Food, Drug and Cosmetic Act, in particular its repeated use of the word “shall,” gave the FDA no such discretion. We wrote about that decision here.

Since then, the FDA has banned the importation of thiopental sodium. And that’s where Texas comes in. Texas needs thiopental sodium for its lethal injection program. In 2015, Texas attempted to import thiopental sodium to be used in its lethal injection protocol, and the FDA detained it. On April 20, 2017, after a lengthy administrative process, the FDA reached (what Texas calls) a final decision, holding firm to its determination that it must follow the Beaty decision and ban the importation of thiopental sodium.

And so, just over a week ago, the Texas Department of Criminal Justice filed an amended complaint in federal court in Texas challenging the FDA’s determination. Texas, however, does not claim that the FDA does in fact have the enforcement discretion necessary to allow thiopental sodium into the country. Instead, it tries to shift the focus of the dispute, claiming that thiopental sodium is not misbranded and that its distribution does not require FDA approval.

In particular, Texas claims that thiopental sodium does not meet the FDCA’s definition of a “new drug” and therefore does not require FDA approval. Under the FDCA, a drug is a “new drug” requiring approval if it is not generally recognized by experts “as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.” 21 U.S.C § 321(p). Texas claims that the labeling of the thiopental sodium it imported makes no statements about its use at all and, therefore, it does not qualify as a new drug that requires approval. Texas also claims that its proposed use of thiopental sodium falls under a “law enforcement” exception (21 C.F.R. § 201.125) to the statutory requirement that a drug come with instructions for use and, therefore, the thiopental sodium was not “misbranded” for failure to come with such instructions.

Well, these are certainly interesting claims, ones that we are quite sure that the FDA will fight. In fact, the FDA’s administrative decision states that it doesn’t buy this arguments. The FDA believes that the statements made on the thiopental sodium packaging, as limited as they are, suggest its use for lethal injections and therefore constitute labeling requiring its approval as a new drug. It also believes that the “law enforcement” exception does not apply when the drug is to be administered to humans.

From our point of view, we know that a regulatory agency like the FDA is not going to accept a claim that limits it authority or jurisdiction without a fight—particularly when, as here, it addresses whether the FDA must approve a “new drug,” one of the most important roles that the FDA plays. Accordingly, this litigation will address important issues related to labeling and “new drugs,” and we will follow it.

‘Pointing to the empty chair’ is a well-known defense trial tactic.  It allows the defendant to go on offense.  Maybe the plaintiff deserves some compensation, so the narrative goes, but the plaintiffs sued the wrong party.  If the jury believes that narrative, it might exonerate the defendant completely.  Or it might at least assign some percentage of fault elsewhere and reduce the damage award.

 

Playing the blame game can be a way of redirecting jury anger.  It can also be tricky.  Is pointing to the empty chair inconsistent with major defense themes?  If you’re saying that an injury is not real, or not so bad, or was caused by something completely different, can you also say that non-party X should be on the hook?  The great Texas trial lawyer Racehorse Haynes died last week.  He won some trials that nobody thought were winnable.  He famously told a story about how he would defend a dog-bite case:

 

Say you sue me because you say my dog bit you. Well, now this is my defense:

My dog doesn’t bite.

And second, in the alternative, my dog was tied up that night.

And third, I don’t believe you really got bit.

And fourth, I don’t have a dog.

 

Of course, a little too much of that alternative pleading and the jury might start to doubt the lawyer’s credibility.  Here, we are talking about a slightly different defense:  some other dog bit you.  That other dog might be a health care practitioner.  But, as is often the case, doctors sometimes get special, favorable treatment from the judicial system.  In some jurisdictions, a defendant cannot point to a non-party doctor at all, or can do so only by making out a prima facie case of medical malpractice, complete with an expert opinion.  (At this point we are not even getting into the fact that many of our clients do not ever want to point the finger at a doctor, whether that doctor is a co-defendant or is a non-occupant of the empty chair.  Granted, the latter is much easier conceptually if not practically.) 

 

The toughest version of the empty chair defense is trying to pin blame on an actor that enjoys some degree of immunity.  That is what happened in the eccentric case of In re New England Compounding Pharmacy, Inc., Prods. Liab. Litigation, 2017 WL 1458192 (D. Mass. April 24, 2017).  The plaintiffs alleged that contaminated compounded drugs hurt a lot of people.  The main defendant  went bankrupt, so the plaintiffs went about suing all manner of unusual defendants on unusual theories.  A couple of relatively minor defendants asserted the comparative fault of the FDA, the Massachusetts Board of Pharmacy (“MBOP”), and some Tennessee governmental entities.  The Plaintiffs’ Steering Committee (“PSC”) moved for judgment on the pleadings against those defendants.  They won a little and lost a little.  The bit they lost is fascinating and prompts us to speculate on all sorts of outlandish possibilities. 

 

But first to the part the PSC won.  The Tennessee public duty doctrine shields public employees from suits for injuries caused by the breach of a duty owed to the public at large.  A duty owed to everyone turns out to be a duty owed to no one.  The public duty doctrine renders the public actors immune from duty and immune from fault.  Therefore, there can be no comparative fault laid at the door of such public actors.  Of course there is an exception to the rule of non-liability.  It seems there are always exceptions to non-liability rules.  That exception is triggered when the public employee owes a “special duty” to the plaintiff.  Such a special duty arises when, (1) the public employee undertakes to protect the plaintiff, and the plaintiff relies upon such undertaking, (2) a statute specifically creates a cause of action against an official or municipality for injuries resulting to a particular class of individuals, of which the plaintiff is a member, from failure to enforce certain laws, or (3) the public employee acted intentionally, maliciously, or recklessly.  The defendants in this case did not even allege that the Tennessee entities fit into these categories, so those Tennessee entities cannot be the focus of a comparative fault defense.

 

Goodbye Tennessee entities.  Any hopes of dragging them into the case via comparative fault “rode away on a Tennessee stud.”

 

By contrast, the defendants did allege that the FDA and the MBOP acted recklessly.  The defendants alleged that the FDA and MBOP were aware long ago that the compounder had sterility and potency issues, but failed to take any “meaningful, substantive action.”  The FDA had issued a warning letter to the compounder but, according to the defendants, never followed up appropriately.  Viewing the defendants’ allegations in the light most favorable to them, the court concluded that the comparative fault defense lived to fight on in the case.  Perhaps it will be tested again. 

 

Meanwhile, one cannot help but wonder how an FDA comparative fault defense might play out in future cases.  Many drug or device defendants face the issue of how much to highlight the fact of federal regulation in defending against liability.  It seems a worthwhile point to make, if only to let the jury know that companies cannot unleash products on the populace without some sort of review, clearance, and/or approval from the FDA.  We know of one court that has held that a 510(k) clearance is so meaningless as to merit preclusion from trial, but that opinion seems to be an outlier.  More often, the decision for the defendant is whether the fact of FDA regulation is worth the inevitable onslaught from plaintiffs and their experts about how the FDA is allegedly a paper tiger.   But now that we have read the New England Compounding case, we wonder whether that plaintiff onslaught potentially sets up a comparative fault defense — that the FDA acted recklessly in not initiating stricter enforcement action.  That would be a weird and risky position for a defendant to take.  But if the plaintiffs are doing everything they can to make the case, why not take advantage of it?  Still, there are wrinkles everywhere in such a scenario.  The Food, Drug and Cosmetics Act affords the FDA with discretion.  See 21 U.S.C. §336 (“Nothing in this chapter shall be construed as requiring the Secretary to report for prosecution . . . whenever he believes that the public interest will be adequately served by a suitable written notice or warning”). Such discretion might protect the FDA from suit under the Federal Tort Claims Act.  It might even preempt this kind of argument. We don’t know, because we haven’t seen it before.  Even aside from that legal impediment, given FDA discretion, the concept of a common-law duty owed to any person to enforce the law in a particular way would seem to be a challenging argument.  As to the Massachusetts regulators, the comparative fault theory is intriguing as an empty chair defense, but what if someone tries to fill that empty chair with an actual state entity defendant?  Could parties in one state sue the regulatory bodies of another state for negligence concerning damages caused by a regulated product sold in interstate commerce?  The 11th amendment would seem to be an insuperable barrier, at least in federal court such as this MDL.    

 

Sometimes, weird little one-off rulings in unusual cases do not end up being so one-off.   

 

 

 

We recently read a recent (3/15) Bloomberg piece (here, for those with a subscription) entitled “Off-Label Promotion Could Mean More Drug Company Liability.”  This article consists largely of the interviews with two avatars of the other side of the “v.”:  fellow blogger Max Kennerly (who regularly writes intelligent critiques of our posts) and Lou Bogrod, with whom we’ve tangled before over off-label issues.  Needless to say, we disagree with the “more liability” spin they put on any would-be FDA retreat on off-label promotion.

Here’s why – and we apologize to all of you who can’t read the article we’re responding to, but it’s behind a paywall, but Michael Bloomberg didn’t get to be a billionaire by giving things away that he could charge for (that’s what we do).  Like the Bloomberg article, we’re also limiting our focus to product liability, recognizing that truthful off-label promotion also arises frequently in False Claims Act cases.

The first contention is that, once truthful off-label promotion is legal, “drug companies would lose the protection afforded by preemption.”  We don’t think that’s grounds for “more liability.”  First of all, “drug companies” – at least those making innovative branded drugs, don’t have much of a preemption defense.  The Supreme Court unfortunately took care of that in Wyeth v. Levine, 555 U.S. 555 (2009), limiting preemption to cases of “clear evidence” that the FDA would have rejected the label change in question.  There are other possible preemption grounds concerning design defect claims (which we’ve advocated here), but off-label promotion doesn’t involve design.  So, while there may be liability issues raised concerning specific instances of off-label promotion, we don’t see any basis for calling it “more” liability than already exists for on-label promotion.  Most branded drug warnings don’t have a preemption defense now.

Indeed, the result could very well be less liability. Even if truthful off-label promotion were to become broadly legal, the off-label use itself remains off-label.  The FDA, however, can order a drug’s label to contain statements (usually warnings) about an off-label use.  21 C.F.R. §§201.57(c)(6)(i), 201.80(e) (both phrased in terms of “required by” the FDA).  That’s important because, as we discussed in more detail here, only the FDA can do this.  Drug companies are not allowed to discuss off-label uses in their labels whenever they want.  Without the FDA telling them to, that is a form of misbranding.

Continue Reading What If We Win? Off-Label Promotion & Product Liability

This post comes from the Cozen O’Connor side of the blog.

We’ve been following the Pinnacle MDL closely through the last two bellwether trials, starting with the news coming out of the second bellwether trial of particularly curious and prejudicial evidence being presented to the jury. Given that evidence, we expected a plaintiffs’ victory, an expectation that was borne out with a whopping $498 million verdict. It raised an immediate question: “What will the Fifth Circuit do?”

Well, we’re on our way to finding out. The defense recently filed their opening appellate brief. While it features the controversial evidentiary rulings, much more is in play. If you would like to take a look for yourself, here is the brief.  Below are some of the key issues, along with a quick description of the defense’s arguments:

Design Defect Claim against DePuy (Brief at 20-29): Claim that all metal-on-metal hip implants are defective is not viable under Texas law because a wholly different product cannot serve as a safer design; design claim is preempted because the FDA approved metal-on-metal hip implants; and design claim fails under Restatement (Second) of Torts 402A comment k (adopted in Texas), which recognizes that products like implantable devices are unavoidably unsafe and therefore not defective if properly made and warned about.

Continue Reading Briefing Underway in Appeal of Half-Billion-Dollar Verdict in Pinnacle MDL

Today’s post is on a short decision from the Court of Appeals of Florida, but it is important. In drug and device litigation, defendants are almost always required to produce the adverse event reports related to the product at issue based on the argument that they go to notice. Beyond notice we take strong issue with their admissibility. Take a look at our AER cheat sheet.  And with so many courts excluding them from evidence, extensive discovery of adverse events is something defendants should push back on. As part of that push back, defendants should never overlook raising the burden of redacting from any adverse event report any information that identifies either the voluntary reporter (physicians, consumers) or the person who used the drug or device (if not one and the same). If you’ve made that argument, you may have had a court question whether redaction is really necessary. The answer is an unequivocal yes.

The FDA requires manufacturers to maintain the confidentiality of this information.

The names and any information that would identify the voluntary reporter or any other person associated with an adverse event involving a human drug, biologic, or medical device product shall not be disclosed by the Food and Drug Administration or by a manufacturer in possession of such reports in response to a request, demand, or order. Information that would identify the voluntary reporter or persons identified in the report includes, but is not limited to, the name, address, institution, or any other information that would lead to the identities of the reporter or persons identified in a report.

21 C.F.R. §20.63(f) (emphasis added). So, whether plaintiffs request them or the court orders their production, the manufacturer is obligated to redact adverse event reports before producing them. So, from a practical standpoint, time must be built into any schedule to allow for this redaction to take place. Further, if plaintiffs’ adverse event request is overly broad, you might have grounds to ask for cost-shifting or at least cost-sharing. May help to refocus plaintiffs on what they really want/need.

Continue Reading Protecting Foreign Adverse Events

Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k “substantially equivalence” medical device clearance as non-preemptive because it was supposedly “focused on equivalence, not safety”?  Id. at 493.  In the same vein:

“[S]ubstantial equivalence determinations provide little protection to the public. These determinations simply compare a post − 1976 device to a pre − 1976 device to ascertain whether the later device is no more dangerous and no less effective than the earlier device. If the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective.”

Id. (quoting from pro-plaintiff law review article).

Most of our readers know that this characterization, assuming it was true for the 1980s-era (implanted 1987) device that the Court considered in Lohr, was no longer true, even at the time Lohr was decided, and certainly hasn’t been the case since the FDAAA was passed a year after Lohr was decided.  Still, this anachronistic view of §510k has flourished for twenty years, affecting first preemption and now (thanks mostly to Mesh MDL rulings) admissibility of evidence.

That’s why we were interested in what the FDA had to say about today’s §510k clearance process in its recent memorandum entitled “Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products,” which is available here.  One of our guest bloggers, Liz Minerd, recently discussed the First Amendment aspects of that document, here.

Continue Reading FDA Off-Label Promotion Memo Should Affect §510k Preemption & Evidence

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.

*********

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.

Continue Reading Guest Post – Midnight Madness − The FDA Continues To Discount First Amendment Implications Of Restrictions On Off-Label Promotion