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Amarin, FDA To Discuss Settling Off-Label Promotion Dispute
By John Kennedy
Law360, New York (August 28, 2015, 5:38 PM ET) -- Amarin Pharma Inc. and the U.S. Food and Drug Administration have agreed to discuss settlement options following the company's landmark win in a suit in which a New York federal judge upheld drugmakers' right to truthfully promote their products' unapproved uses, Amarin's lawyers said in a Friday letter.
The letter to U.S. District Judge Paul A. Engelmayer said that the parties “have agreed to explore the possibility of a settlement,” and that they want any further proceedings to be stayed until Oct. 30, when they'll file a joint letter advising the court of possible next steps.
On Aug. 7, Judge Engelmayer ruled that Amarin has a constitutional right to make certain truthful and non-misleading statements about unapproved, or off-label, uses of the omega-3 drug Vascepa, striking a blow to the FDA's restrictions on product marketing.
Both the FDA and Amarin declined to comment Friday regarding the letter and the role it may play in the FDA's decision to appeal the injunction.
Engelmayer's ruling said that Amarin can make certain truthful statements about Vascepa's potential benefits for patients with “persistently high triglycerides” — a population it lacks FDA approval to treat — without fear of prosecution.
The agency had argued that these statements, even if true, signal a company's intent to promote their products for off-label uses and can put them in the agency's crosshairs. However, Judge Engelmayer found that these statements are protected by the First Amendment as long as they're truthful and not misleading.
His opinion was based largely on the Second Circuit's decision in U.S. v. Caronia, which overturned a pharmaceutical sales representative's conviction for off-label promotion involving truthful speech. The FDA has argued that the Caronia decision doesn't prevent it from punishing truthful speech that demonstrates intent to promote off-label uses, but Judge Engelmayer disagreed.
“The court's considered and firm view is that, under Caronia, the FDA may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment,” the judge wrote.
Amarin can now legally make several specific statements, including the assertion that “supportive but not conclusive research” suggests that omega-3 fatty acids help to prevent coronary artery disease, the judge said. Dietary supplements with omega-3 fatty acids are already allowed to carry the same assertion, something that Amarin pointed out in alleging unfair treatment.
Amarin is represented by Floyd Abrams, Joel Kurtzberg and Michael B. Weiss of Cahill Gordon & Reindel LLP.
The FDA is represented by Preet Bharara, Ellen London, Benjamin C. Mizer, Jonathan F. Olin, Scott R. Mcintosh, Michael S. Blume, Andrew E. Clark and Kerala T. Cowart of the U.S. Department of Justice and William B. Schultz, Elizabeth H. Dickinson, Annamarie Kempic, Karen Schifter and Julie Dohm of the U.S. Department of Health and Human Services.
The case is Amarin Pharma Inc., et al., v. Food and Drug Administration, et al., case number 1:15-cv-03588, in the U.S. District Court for the Southern District of New York.
--Additional reporting by Jeff Overley and Sindhu Sundar. Editing by Philip She
FDA, Amarin Bash Watson's Bid To Join Exclusivity Fight
Share us on: By Jeff Overley
Law360, New York (August 11, 2015, 8:53 PM ET) -- The U.S. Food and Drug Administration and Amarin Pharmaceuticals Ireland Ltd. attacked efforts by Watson Laboratories Inc. to appeal a recent D.C. federal court decision on exclusivity for omega-3 drug Vascepa, arguing Monday that the company’s proposed intervention is premature.
In separate filings, the FDA and Amarin both opposed Watson’s bid to appeal a recent D.C. district court decision, arguing that the decision is not final and therefore not appealable. The decision vacated the FDA’s denial of five-year new-drug exclusivity for Vascepa, which Watson wants to copy with a generic version, and remanded the matter to the agency for reconsideration. Monday’s filings argued that Watson must await the outcome of that new review.
“As the proceedings required of FDA on remand are plainly more than ministerial, the court’s ... remand order is not an appealable final order,” according to the FDA’s filing.
Amarin echoed that point, telling the district court that “it is black-letter law that an order remanding a case to an agency is a nonfinal order that cannot be appealed by any party other than the agency itself.”
Counsel for Watson could not immediately be reached for comment Tuesday.
Prior to the May decision, Vascepa only had three years of market exclusivity. If the FDA ultimately awards five years, it will delay copycat versions by more than two years because of spillover effects on the filing of generic-drug applications. Watson, a division of Allergan Inc., also fears that it will lose its sole rights to 180-day exclusivity as the first filer of an application to copy Vascepa.
The FDA could have appealed the May decision, but it presumably doesn’t want to gamble on losing at the D.C. Circuit and getting stuck with a precedential opinion.
Monday’s filing by the FDA was based largely on a 2001 D.C. Circuit ruling in Smoke v. Norton, which reviewed a highly similar situation. A concurring opinion in that case asked whether the intervenor could have appealed if it had originally been a party to the case and concluded that it could not because “significant further proceedings” were still looming on remand. The FDA argued that the same logic applies to the remand in Amarin’s suit.
Amarin went into far more detail expressing its opposition, arguing that Watson lacks a legally cognizable interest at this point, among other things.
Although the district court has not yet ruled on Watson’s motion, the D.C. Circuit recently docketed the case for appeal and set out a schedule for briefing. The FDA on Tuesday acknowledged that development but also wrote that the district court “clearly has jurisdiction to deny the intervention motion.”
Watson is represented by Brett A. Shumate and James N. Czaban of Wiley Rein LLP.
Amarin is represented by Christopher N. Sipes, Benjamin C. Block and Bradley K. Ervin of Covington & Burling LLP.
The FDA is represented by Ann F. Entwistle, Benjamin C. Mizer and Michael S. Blume of the U.S. Department of Justice and William B. Schultz, Elizabeth H. Dickinson, Annamarie Kempic and Shoshana Hutchinson of the U.S. Department of Health and Human Services.
The case is Amarin Pharmaceuticals Ireland Ltd. v. Food and Drug Administration et al., case number 1:14-cv-00324, in the U.S. District Court for the District of Columbia.
--Editing by Edrienne Su.
Amarin Off-Label Promotion Decision: A Watched Pot Boils
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Law360, New York (August 12, 2015, 10:43 AM ET) --
Paul A. Weissman %>
Paul A. Weissman
It is now just over 21 years since the 1994 filing of the groundbreaking case of Washington Legal Foundation v. Kessler,[1] in which the courts first began to wrestle with a key question for the drug and device industries: consistent with the First Amendment, may the FDA prohibit manufacturers from disseminating truthful, nonmisleading scientific information to doctors to promote their products for uses that have not been approved by the FDA? As litigants have repeatedly advised various courts, not only may doctors legally prescribe drugs and devices for unapproved uses, but such off-label uses are integral to the practice of modern medicine. Yet after all this time, while the above question has often been raised in legal proceedings, its answer remains disputed. Remarkably, in fact, as of Aug. 7, 2015, at 9:00 a.m., the government’s position was that the question had never been squarely decided by a single court, apart from a ruling in the Washington Legal Foundation (WLF) litigation that is no longer in effect.
On Aug. 7, however, a new chapter in this story was opened by a landmark ruling issued by District Judge Paul A. Engelmayer of the Southern District of New York in the case of Amarin Pharma Inc. v. FDA.[2] In this suit, which Amarin filed in May 2015, the company seeks a declaratory judgment that communications it wishes to make to doctors promoting its drug Vascepa for an off-label use are protected by the First Amendment, as well as an order enjoining the FDA and the DOJ from taking action to penalize those communications. In a careful and scholarly opinion, Judge Engelmayer found that Amarin was likely to prevail on the core First Amendment issue and entered a preliminary order declaring that the company could not be prosecuted for engaging in truthful and nonmisleading speech promoting the off-label use.
This ruling is only the first round in what promises to be a drawn-out legal contest. Absent a highly unlikely settlement that upends the ruling, the government will now seek to overturn it in further district court proceedings and, if necessary, will almost certainly appeal to the Second Circuit and the Supreme Court. But Judge Engelmayer’s decision, or one very like it, has for some time seemed almost inevitable. In recent years, the government’s position on off-label promotion has come to appear increasingly untenable in light of the constitutional arguments raised against it in a variety of legal and factual settings. The Amarin decision may thus prove difficult to overturn and may help ensure that the wobbly legal constructs the government has long relied on as a basis for its off-label enforcement will at last receive a decent burial.
The Years-Long Failure to Resolve the Issue
The lengthy delay in making law in this area has been primarily due to a single circumstance: a strong reluctance on the FDA’s part to allow a case to get far enough for a court to render a definitive decision. The district court initially ruled in the WLF litigation that the FDA’s restrictions on manufacturers’ dissemination of scientific information about off-label uses violated the First Amendment, but the FDA effectively mooted the controversy by relaxing its legal position on appeal, leading the Court of Appeals to vacate the lower court’s ruling.[3] In later years, two pharmaceutical manufacturers, Par Pharmaceuticals Companies Inc. and Allergan Inc., that found themselves under federal investigation for alleged off-label promotion filed lawsuits for a declaratory judgment that their prosecution would violate the First Amendment,[4] but both companies eventually settled their government investigations and dismissed their suits. While the companies were doubtless responding to the threat of exclusion from government health care programs that the government routinely employs to force litigation settlements, it is likely that the government was also eager to rid itself of their First Amendment challenges. Also in recent years, a number of companies have raised First Amendment defenses either in government enforcement actions or in False Claims Act suits in which relators allege that by promoting their drugs off-label, the companies have caused government health care programs to pay for prescriptions that were ineligible for reimbursement. As yet, however, none of these cases has produced a judicial decision directly addressing the First Amendment question.
Before Aug. 7, the closest thing to a clear-cut ruling as to whether the First Amendment permits the FDA to bar truthful, nonmisleading off-label promotion was the 2012 decision by a divided panel of the Second Circuit in the widely noted case of U.S. v. Caronia.[5] Caronia, a sales consultant for a pharmaceutical manufacturer, was convicted at trial of a misdemeanor conspiracy to introduce a misbranded drug, Xyrem, into interstate commerce, in violation of 21 U.S.C. § 331(a). This charge was predicated on the allegation that Caronia and others had marketed Xyrem for off-label indications, but since the Federal Food Drug and Cosmetic Act nowhere expressly prohibits the act of off-label marketing, the charge was at least loosely based on the elaborate and convoluted charging theory, derived from a patchwork of provisions, that the DOJ and the FDA typically rely on to bring off-label cases. The linchpin of this theory is that, under a number of interlocking FDA regulations, a prescription drug is misbranded if its labeling does not bear “adequate information for its use ... for the purposes for which it is intended, including all purposes for which it is advertised or represented.”[6] An “intended” use of the drug is one that is objectively intended by the persons legally responsible for its labeling.[7] According to the DOJ and the FDA, whenever a drug is promoted for an off-label use, that use becomes an intended one and because the label by definition does not include directions for off-label uses, the drug immediately becomes misbranded for purposes of 21 U.S.C. § 331(a).
The Second Circuit vacated Caronia’s conviction, but only after it had examined the problematic way in which the case had been prosecuted and tried. The trial court, it found, had allowed the government to argue that it was unlawful simply to engage in off-label promotion — that is, that Caronia had committed a crime merely by speaking certain words. The panel then held that the First Amendment did not permit a conviction on this ground, but in doing so it noted — albeit with no evident enthusiasm — that the government might have sought instead to introduce Caronia’s speech solely as evidence of the intended off-label uses of Xyrem. Slender though this distinction was, the government has clung to it as a vital lifeline. Since the Second Circuit’s decision, the government has consistently asserted that Caronia does not significantly constrain its ability to take enforcement action against off-label promotion because the First Amendment does not bar it from using such promotion as evidence of an intended use of a drug that may support a misbranding charge. Tellingly, to avoid the risk that it might lose the ability to spin Caronia in this manner, the government declined to seek review of the case either in the Second Circuit en banc or in the Supreme Court.
The Challenge to the Government’s Theories
However, avoiding the courtroom has not helped the government conceal the weakness of its off-label enforcement theories. For example, opponents have noted that, under the FDA’s expansive definition of intent, a manufacturer could commit a crime just by causing a drug to be shipped to a doctor who is known to use it off-label. The fact that the company was aware of the impending off-label use appears to be enough to make that use “intended” and to render the shipment misbranded. The Second Circuit itself pointed to a resulting conundrum in Caronia, when it said, in addressing the government’s speech-as-evidence theory:
[I]t still remains unclear how the government would identify criminal misbranding from communications between drug manufacturers and physicians ... For example, would a manufacturer be guilty of misbranding if it ships Xyrem to a doctor who ... reveals that he prescribes the drug for off-label use — on a theory that the manufacturer now knows that the drug is not properly labeled for that use — but not if the manufacturer ships to a doctor who does not reveal that he prescribes the drug off-label?[8]
Similar puzzles were presented to the courts in the Par and Allergan suits. Par asserted that the threat of FDA enforcement action was preventing it from promoting its AIDS-wasting drug Megace ES in long-term care facilities and oncology practices even for its approved use, since the drug was widely used off-label to treat wasting in geriatric and cancer patients and the FDA had indicated that even purely on-label speech by Par in such settings might be sufficient to misbrand the drug. Allergan declared that it feared being sanctioned if it proactively provided important safety information about the therapeutic version of Botox to the many physicians known to prescribe it off-label. Though Allergen was in a unique position to disseminate such information, it argued, it had been “silenced by a two-faced legal regime that encourages widespread off-label use but requires the manufacturer to pretend that the off-label use is not occurring ... ”[9]
Applied in circumstances like these, the FDA’s off-label promotion legal regime clearly sweeps too broadly and fails to meet the test the Supreme Court has laid down for restrictions on truthful commercial speech unrelated to illegal activity: that such a restriction must not only advance a substantial government interest, but must do so without being more extensive than necessary to serve that interest.[10] Implicitly conceding this point at least in part, the government responded to Par’s and Allergan’s claims by indignantly asserting that it exercises appropriate discretion and would not bring off-label promotion charges to punish unobjectionable conduct. Thus, the government asserted in the Allergan case that “In practice, the FDA usually does not treat an unapproved use as an intended use solely because the manufacturer knows that the unapproved use is taking place.”[11] But limitations such as this that the government voluntarily imposes on its off-label enforcement have invariably been hedged with qualifications like the word “usually” in this sentence, and in any event these limitations are nowhere to be found in the law. Prosecutors have accordingly retained wide-ranging power to charge the crime of off-label promotion for communications with doctors that even the FDA regards as inoffensive. The contention that such untrammeled prosecutorial power itself offends the First Amendment is a powerful one. As Allergan argued to the court, “The First Amendment does not permit the government to criminalize a broad category of truthful speech and relegate citizens to trusting in prosecutorial grace.”[12]
Meanwhile, it has become evident that a serious overinclusiveness problem also afflicts the government’s theories in the FCA arena. The government has asserted in statements of interest it has filed in support of qui tam relators that even a manufacturer’s truthful and nonmisleading speech — for example, its dissemination of peer-reviewed medical journal articles to doctors — may make the manufacturer liable for causing false claims for reimbursement to be filed with government health care programs. The potentially false claims created by distributing journal articles, according to the government, are claims for prescriptions for off-label uses discussed in the articles that may be ineligible for reimbursement. Though the great majority of off-label scripts are actually eligible to be reimbursed, because they are for medically accepted uses, the government appears to regard this fact as irrelevant to its analysis.
Manufacturers have contended that, since the government’s theory impinges on free scientific discussion, and since in any case it is doctors, not manufacturers, who decide whether off-label prescriptions will be written, courts should avoid a conflict between the FCA and the First Amendment by requiring proof of a direct causal connection between manufacturers’ truthful, nonmisleading off-label speech to doctors and the submission of any false claim under the FCA. In response, the DOJ has insisted that the FCA should be governed only by the common-law standard of tort causation — that “the causation inquiry is whether it was reasonably foreseeable that the defendants’ conduct or statements would influence the submission of ... false claims ... ”[13] But the position so confidently asserted by the DOJ would expand potential FCA liability to an almost breathtaking extent. If a manufacturer may be subjected to treble damages under the FCA because it was reasonably foreseeable that the manufacturer’s distribution of the results of a clinical trial involving an off-label use would “influence” the submission of off-label claims, why not a doctor who shares these results with another doctor? Why not the journal in which the results were published or even the researchers who conducted the trial?
And Now, the Amarin Case
Amarin’s suit may present the clearest case yet of a situation in which the FDA’s rules against off-label promotion appear vastly overbroad and misguided. The case has thus furnished Amarin’s lawyers with a nearly ideal platform from which to launch a First Amendment attack.
Amarin’s drug Vascepa is a form of an omega-3 fatty acid that is approved to treat patients with very high triglyceride levels. Seeking to expand the drug’s label, Amarin conducted the ANCHOR trial of Vascepa in patients with only somewhat high triglyceride levels, under an agreement with the FDA which contended that the FDA would approve use of the drug in such patients if the trial succeeded. However, though ANCHOR in fact yielded positive results, the FDA subsequently rescinded its agreement and declined to approve the additional use, citing a change in its view as to the type of data this would require. As a result, under FDA rules Amarin cannot freely discuss the positive ANCHOR data with doctors. This bar, Amarin contends, withholds much-needed information from doctors, many of whom are treating patients for somewhat high triglyceride levels with products that have a worse safety profile than Vascepa and may be inferior to it in other respects. Moreover, some omega-3 fatty acid products are marketed as dietary supplements, which are subject to far looser FDA regulation than prescription drugs and are often promoted with the claim that omega-3 fatty acids may reduce the risk of coronary heart disease. Amarin, by contrast, has been prohibited from making this claim for Vascepa, which means it has been unable to provide information to trained medical personnel that is routinely provided to lay consumers purchasing an over-the-counter product. Adding insult to injury, perhaps, the FDA itself has pointed out to Amarin that it could make this claim with impunity if it would only repackage Vascepa as a dietary supplement.
Presented with these striking facts, Judge Engelmayer came down decisively in favor of Amarin’s First Amendment arguments. Rejecting the government’s too-clever-by-half reading of Caronia, he found that the Second Circuit’s decision did not address only prosecutions of the act of speaking off-label, but precluded any prosecution for misbranding, brought on whatever theory, based solely on truthful, nonmisleading off-label speech. “Caronia’s holding,” Judge Engelmayer stated, “was that the FDCA’s misbranding provisions cannot constitutionally criminalize, and therefore do not reach, the act of truthful and nonmisleading speech promoting off-label use.”[14] The court went on to hold specifically that Amarin can freely distribute a summary of the ANCHOR trial to doctors and can make a variety of claims to promote off-label use of Vascepa provided they are accompanied by appropriate language to ensure they are not misleading, including the claim on over-the-counter products relating to coronary heart disease.
To be sure, even if upheld, Judge Engelmayer’s decision would not mark an end to litigation over restraints on off-label promotion. A notable feature of the decision is that the court reviewed the precise wording of Amarin’s permitted claims in great detail, reminding all involved that when a promotional statement should be considered truthful and nonmisleading remains a potentially thorny issue. Further, the court declined a request from Amarin that it also rule on the constitutionality of FCA actions based on truthful off-label promotion, finding that this issue was not ripe. The court stressed at the same time that its decision did not preclude the government from prosecuting any conduct — “noncommunicative activities” — designed to promote off-label uses[15] and the government may well seize upon this conduct/speech distinction to argue that the First Amendment permits FCA suits for off-label promotion even in cases where misbranding actions are out of bounds.
However, the decision by Judge Engelmayer is a watershed event that will greatly assist in clarifying the law concerning off-label promotion. The FDA has announced that it is conducting a comprehensive review of its regulatory regime governing promotion and that it will issue new guidance in this area, though it is not saying when this will happen. At a minimum, the Amarin decision should intimately inform the FDA’s review.
—By Paul A. Weissman, Lowenstein Sandler LLP
5 Questions After Amarin's Off-Label Marketing Triumph
By Jeff Overley
Law360, New York (August 7, 2015, 8:43 PM ET) -- A landmark court decision on Friday allowing truthful and nonmisleading off-label promotion by Amarin Pharma Inc. provides a roadmap for drugmakers to market products more freely, but attorneys say much uncertainty remains about the ruling's impact on criminal misbranding cases and False Claims Act litigation. Here are five questions raised by Amarin’s victory.
Will the FDA Appeal?
The most immediate question is whether the U.S. Food and Drug Administration will appeal to the Second Circuit, which issued the 2012 ruling in U.S. v. Caronia that was the basis for Friday’s free speech ruling in New York federal court.
It’s hard to predict what the FDA will do, in part because there are risks in either scenario. If the agency stands down, its authority to police off-label promotion will be diminished. If the agency appeals, it could lose again and be stuck with a binding circuit court decision that carries even more weight.
“The FDA’s between a rock and a hard place,” Reed Smith LLP counsel James M. Beck said.
But the agency has described Amarin’s lawsuit as a “frontal assault” on the nation’s drug approval process and argued that it seriously threatens longstanding requirements to prove the effectiveness of prescription drugs. If regulators still believe that, an appeal might make sense.
“This is the ‘frontal assault’ case that should have led the government to reconsider its stance on the First Amendment a long time ago,” Sidley Austin LLP partner Coleen Klasmeier said. “I would expect the government to appeal, and the quality and thoroughness of the decision suggests the court expects the government to appeal as well.”
How Will the FDA Adapt?
If the decision ultimately stands, all eyes will be on how the FDA adapts. The question is especially pertinent because Amarin’s victory joins two additional court rulings that have protected truthful speech involving prescription drugs in recent years.
In 2011, the U.S. Supreme Court in Sorrell v. IMS Health shielded the use of truthful information about prescribers to support pharmaceutical marketing. In 2012, the Second Circuit’s Caronia decision shielded a pharmaceutical salesman’s honest discussion of off-label uses.
With a third ruling now on the books, drugmakers and the FDA have come to “a pivotal juncture,” Gibson Dunn partner Marian J. Lee said.
That seems particularly true because the FDA had already agreed to revisit guidance on acceptable off-label communications “in light of emerging case law” involving the First Amendment. After Friday's ruling, the urgency for more leeway and clarity is probably greater than ever.
“A chorus of decisions ... has brought the kettle to boil,” Lee said. “The agency is under mounting pressure to make critical and fundamental changes to its regulation of manufacturer speech and to do so quickly.”
Will Enforcement Impact Be Minor?
Although the FDA is unquestionably feeling heat, it also retains immense power to punish promotion of off-label uses when drugmakers make false or misleading statements. That’s a crucial point because virtually all of the major criminal and civil settlements for off-label promotion — including Johnson & Johnson’s $2.2 billion deal in 2013 and GlaxoSmithKline LLC’s $3 billion payout in 2012 — were premised on dishonest marketing.
“This decision is unlikely to have a substantive effect on the type of off-label promotion of drugs that has been the primary focus of criminal penalties and substantial False Claims Act recoveries,” Constantine Cannon LLP partner Tim McCormack said.
In addition, the decision from U.S. District Judge Paul A. Engelmayer only found that the FDA, under the Caronia ruling, cannot premise enforcement solely on truthful and nonmisleading speech. Judge Engelmayer explicitly said that truthful speech “might be admissible” to help prove separate misconduct, such as a hypothetical situation involving kickbacks, and lawyers called that an important caveat to keep in mind.
“One thing that the court did highlight in the decision was the fact that ... there are limits to this, and one of the limits is that Caronia protects expression, not conduct,” Weil Gotshal & Manges LLP associate Emily L. Pincow said.
How Far Will Ruling Reverberate?
It also remains to be seen how extensively drugmakers will take advantage of Friday’s ruling if it remains in place. There will presumably be many opportunities, given the enormous universe of prescriptions drugs and the widespread practice of off-label prescribing.
“There are lots of very common off-label uses with very well-established safety records,” Beck said.
At the same time, Amarin’s product — an omega-3 drug called Vascepa — has some unique facts that helped the company make its case. For one, the drug’s safety has been deemed equivalent to a placebo in clinical research. It’s also similar to dietary supplements that the FDA allows to make unproven health claims, and it’s been shown to help lower triglycerides.
For other products that don’t have comparable supporting facts, it’s possible that off-label claims would be dicier.
"It’s hard to predict with other facts if the court would have gone the same way,” Pincow said. “So it’s not really clear what can come from this.”
Separately, Amarin's win may help drugmakers wield the First Amendment more aggressively in FCA cases, which frequently end in settlement before any active briefing. After Friday’s decision, it might make increasing sense to at least try to weaken cases by asking judges to rule on free speech issues.
“Defendants will likely wait to try to put the government and the whistleblowers to the test of proving the false or misleading nature of the off-label promotional statements,” McCormack said. “As such, for a while, we will likely see far fewer cases where the defendant agrees to a settlement without any active litigation.”
What Constitutes Truthful Speech?
Even for purportedly truthful communications about off-label indications, Friday’s ruling suggested that drugmakers must still tread lightly. For one thing, although Judge Engelmayer sided with Amarin, he only endorsed specific promotional statements, and he only did so after an exhaustive examination of competing arguments about the phrasing and disclaimers needed to ensure accuracy.
In addition, Judge Engelmayer noted that science evolves over time, potentially taking something that is true one day and making it false the next.
“Amarin bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa remain truthful and nonmisleading,” the judge wrote.
Overall, experts said Friday’s opinion is a reminder that the FDA might not agree with a drugmaker’s views on whether something is truthful and that seeking agency feedback in advance should be considered.
“Manufacturers face some risk if they proceed based on their own determination as to the truthfulness of their speech, and cautious companies may want to get FDA’s take on proposed claims before making them,” Klasmeier said.
--Editing by Chris Yates and Christine Chun.
BREAKING: Amarin Wins Injunction Against FDA Over Off-Label Marketing
By Jeff Overley
Law360, New York (August 7, 2015, 11:21 AM ET) -- A New York federal judge on Friday ruled that Amarin Pharma Inc. has a constitutional right to make certain truthful and nonmisleading statements about off-label uses of omega-3 drug Vascepa, striking a blow to the U.S. Food and Drug Administration’s restrictions on product marketing.
In a 69-page opinion, U.S. District Judge Paul A. Engelmayer granted Amarin's motion for a preliminary injunction, ruling that Amarin can make certain truthful statements about Vascepa’s potential benefits for patients with “persistently high triglycerides” — a population it lacks FDA approval to treat — without fear of prosecution.
Judge Engelmayer said that protection is warranted under the Second Circuit’s landmark 2012 ruling in U.S. v. Caronia, which overturned a pharmaceutical sales representative’s conviction for off-label promotion involving truthful speech.
The preliminary injunction will "eliminate the chill on Amarin’s First Amendment rights," Judge Engelmayer wrote.
The ruling was not a surprise, given comments that Judge Engelmayer made at oral arguments last month.
Amarin is represented by Floyd Abrams, Joel Kurtzberg and Michael B. Weiss of Cahill Gordon & Reindel LLP.
The FDA is represented by Preet Bharara, Ellen London, Benjamin C. Mizer, Jonathan F. Olin, Scott R. Mcintosh, Michael S. Blume, Andrew E. Clark and Kerala T. Cowart of the U.S. Department of Justice and William B. Schultz, Elizabeth H. Dickinson, Annamarie Kempic, Karen Schifter and Julie Dohm of the U.S. Department of Health and Human Services.
The case is Amarin Pharma Inc. et al. v. Food and Drug Administration et al., case number 1:15-cv-03588, in the U.S. District Court for the Southern District of New York.
--Editing by Rebecca Flanagan.
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Watson Moves To Undo Amarin's Exclusivity Win Over FDA
Share us on: By Jeff Overley
Law360, New York (July 22, 2015, 7:09 PM ET) -- Watson Laboratories Inc. on Wednesday moved to eliminate extra exclusivity granted recently for Amarin Pharmaceuticals Ireland Ltd.’s omega-3 drug Vascepa, appealing to the D.C. Circuit and asking for permission to take over litigation from the U.S. Food and Drug Administration.
The unusual development concerns a district court ruling in May that found the FDA owed Amarin five years of new-drug exclusivity for Vascepa instead of three years of new-use exclusivity. Watson seeks to introduce a generic version of Vascepa that would be delayed by the May ruling, and it says that the FDA has made a “definitive decision” not to appeal, forcing it to take the agency’s place.
On Wednesday, Watson filed a one-page notice of appeal to the D.C. Circuit and an 18-page motion explaining to the district court why it should be permitted to intervene in the matter. Large sections of the motion were redacted, and visible sections simply discussed Watson’s interests in the case, as opposed to why it thinks the district judge was wrong.
As Amarin has previously acknowledged, Watson noted that the effect of new-drug exclusivity is more than just two years because it requires resubmission of applications for generic versions at a later date. As a result, the earliest approval for a generic would come in January 2020, according to Watson.
Moreover, the resubmission requirement would likely result in Watson losing the 180-day exclusivity that comes with its current status as first filer of an application to copy Vascepa, according to the motion. That’s because other applications for generic Vascepa have subsequently been submitted, meaning that rivals have caught up with Watson and would likely resubmit along with it as soon as they are allowed, the motion said.
In that scenario, “Watson’s substantial investments in being the first company to submit and gain approval of an [application] for generic Vascepa will be obliterated,” the motion asserted.
A spokesman for Amarin declined to comment.
Watson also made comparisons to a case last year involving exclusivity for an orphan drug produced by Depomed Inc. The FDA lost that suit as well at the district court level and eventually withdrew an appeal to the D.C. Circuit, and Watson said that withdrawal shows that the matter can’t be left to regulators.
“Even if the FDA were to file a notice of appeal, it could later decide to withdraw the appeal, leaving Watson with no recourse unless the court allows intervention now,” the drugmaker wrote.
In addition, any appeal by the FDA would raise larger institutional concerns for the agency, and as a result, the FDA’s interests “may no longer align with Watson’s,” according to the motion.
In 2012, Watson bought Actavis Group and took on its name. Actavis subsequently acquired Allergan Inc. and took on that company's name.
Watson is represented by Brett A. Shumate and James N. Czaban of Wiley Rein LLP.
Amarin is represented by Christopher N. Sipes, Benjamin C. Block and Matthew J. Berns of Covington & Burling LLP.
The case is Amarin Pharmaceuticals Ireland Ltd. v. Food and Drug Administration et al., case number 1:14-cv-00324, in the U.S. District Court for the District of Columbia.
--Editing by Christine Chun.
Judge Grills Amarin, FDA Over Off-Label Promo Statements
Share us on: By Jeff Overley
Law360, New York (July 7, 2015, 6:28 PM ET) -- A New York federal judge on Tuesday appeared unlikely to immunize Amarin Pharma Inc. from punishment by the U.S. Food and Drug Administration for engaging in off-label promotion, while nonetheless suggesting that certain truthful statements may be constitutionally protected.
The signals from U.S. District Judge Paul A. Engelmayer occurred during oral arguments in a constitutional challenge that Amarin launched in May to shield certain statements about unapproved uses of omega-3 drug Vascepa from FDA discipline. At several points, Judge Engelmayer expressed concern about Amarin’s requests, including its pursuit of immunity from a hypothetical enforcement action under the False Claims Act or the Federal Food, Drug and Cosmetic Act.
“It seems quite unusual for me to be asked to issue an order barring a prosecution,” the judge said, wondering aloud about potential infringement of separation of powers.
Instead of flatly prohibiting punishment for truthful communications, Judge Engelmayer said he may be willing to declare that certain truthful statements about Vascepa are protected speech under the First Amendment. Much of Tuesday’s hearing was focused on how exactly those statements should be phrased and whether there is phrasing that Amarin and the FDA could both find acceptable.
Amarin’s lawsuit proposed various statements, and the FDA responded last month by embracing some of the statements and offering revisions that Judge Engelmayer on Tuesday said would add “valuable perspective” to Amarin’s promotions.
Cahill Gordon & Reindel LLP partner Floyd Abrams, counsel for Amarin, gave some ground on that point, saying the FDA’s response was “a serious step forward” for the company.
The parties have continued to trade ideas, so a meeting of the minds could occur and eliminate the need for Judge Engelmayer to even rule in the case. Alternately, the judge said he may look at the remaining points of contention and decide what form the statements should take.
However, he also said that a court declaration of truthfulness is risky, given that science is always evolving. For example, Amarin wants to say that “supportive but not conclusive research” suggests that Vascepa may improve heart health. But it’s possible that future research will show there is no such benefit, Judge Engelmayer said.
“What happens then?” he asked.
In response, Abrams suggested that the FDA could ask the court to modify any order. But Ellen London, an assistant U.S. attorney who argued for the FDA, told Judge Engelmayer that “the onus should be on Amarin to report back to the court” in such a situation.
London also argued that such concerns underscore the problems with courts determining that certain statements should be allowed instead of leaving the job to public health experts at the FDA, as Judge Engelmayer could ultimately decide to do.
On a separate point, Judge Engelmayer also noted that the FDA, as a result of earlier litigation, allows omega-3 dietary supplements to make the same heart-health claim about “supportive but not conclusive research.”
London emphasized that over-the-counter supplements are held to a lower standard of evidence than prescription drugs, but Judge Engelmayer appeared to be struck by the disparate treatment of highly similar products.
”This case is quite unusual” because of that disparity, Judge Engelmayer said.
Tuesday’s argument also featured discussion of the Second Circuit’s 2012 ruling in U.S. v. Caronia. That decision, which is binding in New York, overturned a sales representative’s misdemeanor conviction for truthful and nonmisleading off-label marketing as an improper prosecution of protected speech. But the decision also tentatively assumed that the government could use truthful speech as evidence of illicit intent.
London advanced an aggressive interpretation of the Caronia decision, arguing that truthful statements alone can still be the basis for enforcement if the government demonstrates that a drug was promoted for unapproved uses that weren’t generally recognized as safe and effective.
Judge Engelmayer agreed that truthful statements could be used as evidence of illicit intent, but he also questioned how they could be used in isolation to support an enforcement action.
“If all you’ve got is [truthful] speech and nothing more, aren’t you flatly inconsistent with Caronia?” he asked.
Ultimately, Judge Engelmayer suggested he was somewhat torn on how to proceed, telling attorneys that their written briefing was “as good as it gets” and that rock-solid advocacy had continued at Tuesday’s hearing.
"This has been a terrific argument on both sides,” the judge said. “You’ve given me a lot to think about.”
Amarin is represented by Floyd Abrams, Joel Kurtzberg and Michael B. Weiss of Cahill Gordon & Reindel LLP.
The FDA is represented by Preet Bharara, Ellen London, Benjamin C. Mizer, Jonathan F. Olin, Scott R. Mcintosh, Michael S. Blume, Andrew E. Clark and Kerala T. Cowart of the U.S. Department of Justice and William B. Schultz, Elizabeth H. Dickinson, Annamarie Kempic, Karen Schifter and Julie Dohm of the U.S. Department of Health and Human Services.
The case is Amarin Pharma Inc. et al. v. Food and Drug Administration et al., case number 1:15-cv-03588, in the U.S. District Court for the Southern District of New York.
--Editing by Brian Baresch.
HD, a great summary. I agree with everything you stated except Amarin won't sue for SPA or damages. I personally believe if Amarin wins the injunction and the over all case they would be stupid not to explore all options. The expression 'blood is in the water' comes to mind and the Amarin attorneys will need to do all they can to protect the company going forward. The FDA will continue to try to bring down Amarin going into the Reduce-IT review.