Just this week, I blogged about the FDA’s letter and opposition in response to Amarin Pharma, Inc.’s complaint challenging regulations that prohibit the distribution of “off-label” information.  See June 30 Blog.  On Tuesday, the pharmaceutical company filed a reply in response, attacking the FDA’s actions, claiming that the FDA’s June 5th letter and opposition are all too “familiar to students of its prior behavior,” which Amarin claims is to “escape [] First Amendment-centered judicial review[.]”  Specifically, Amarin states that “[n]othing in the FDA’s June 5 letter to Amarin or in its brief…recognizes the company’s First Amendment right to do or say any of [the] things” it sought to do in its Complaint.  Although acknowledging the “inherent tension between the FDA’s interest in protecting patients” while at the same time “ensuring that drugs meet FDA’s ‘gold standard[,]’” Amarin argues that such tension is “not a basis for limiting First Amendment-protected free speech.”

Although the FDA claimed in its opposition that the majority of the issues alleged are no longer viable in light of its recent letter, Amarin argues that the issues involved are “far more” than the FDA asserts and do, in fact, present a live controversy.  In doing so, Amarin relies on the FDA’s recent “Complete Response Letter,” which informed Amarin that it could face prosecution under the FDCA’s “misbranding” provisions if Vascepa is marketed for off-label use.  Furthermore, Amarin emphasizes that even the FDA’s June 5th letter “reasserted” the FDA’s authority to pursue “misbranding prosecutions for off-label promotion.”  Moreover, Amarin asserts that the only thing the June 5th letter made clear was that Amarin can only “safely” engage in its proposed conduct on the FDA’s terms, which is “inconsistent with the First Amendment.” [click to continue…]

Last month, I blogged on Amarin Pharma, Inc.’s complaint against the FDA challenging the agency’s regulations that prohibit the company from disseminating information about a drug’s “off-label” use.  See May Blog.  Since then, the FDA sent Amarin a response letter, which the agency argues greatly narrows the issues before the Court.  In addition, just last week, the FDA filed its opposition, going so far as to state that Plaintiffs’ sought relief “has the potential to establish precedent that would return the country to the pre-1962 era when companies were not required to prove that their drugs were safe and effective[.]”

Although my prior blog post sets forth the facts at issue, the background on the suit is as follows (although this time, from the FDA’s perspective): The FDA approved Vascepa in 2012 for use relating to reducing the risk of pancreatitis from high triglycerides.  Since then, the FDA claims that Amarin has been attempting to obtain approval for a second use that relates to the reduction of the risk of cardiovascular events.  The FDA explains that Amarin conducted the ANCHOR trial, which was accepted by the FDA, despite the fact that the trial measured triglyceride levels and was not designed to directly measure cardiovascular outcomes.  New scientific data became available, however, which directly measured the effect on cardiovascular outcomes and revealed that the drug did not provide any additional benefits.  Consequently, the FDA concluded that there was insufficient scientific evidence that measuring triglyceride levels is an appropriate substitute for measuring cardiovascular outcomes in patients with high triglyceride levels who are already being treated with a statin.  As a result, the FDA rescinded its agreement regarding the ANCHOR trial.  Amarin is now conducting a second trial and expects results in 2018. [click to continue…]

On June 18, 2015, a California federal judge denied a motion by Gerber Products Co. (“Gerber”) seeking to dismiss a putative class action for false advertising an infant formula based, in part, on the primary jurisdiction doctrine.  The court disagreed with Gerber’s argument that the issues raised by plaintiffs in the lawsuit were best left to the U.S. Food and Drug Administration (“FDA”), the agency with expertise on the challenged health claims Gerber used to advertise its infant formula.

Plaintiff’s Complaint alleged that after being introduced to the infant formula Gerber Good Start Gentle by her pediatrician, she researched the product online and reviewed statements on Gerber’s website “highlighting Good Start Gentle’s endorsement by the [Food and Drug Administration (‘FDA’)] and its ability to protect infants from developing allergies.” (Opinion at 1 (citing First Amended Complaint §61)).  As a result of representations by Gerber that the formula reduces the risk of infants developing atopic dermatitis and that the FDA endorsed that health claim, plaintiff claimed she discontinued the use of other formula products and exclusively purchased Good Start Gentle.

Plaintiff filed a putative class action against Gerber on January 9, 2015 seeking certification of a class of “[a]ll persons who have purchased Gerber Good Start Gentle infant formula in California during the applicable statute of limitations.” (Opinion at 2 (citing First Amended Complaint §25).  Federal jurisdiction was asserted under the Class Action Fairness Act.  Defendant moved to dismiss, arguing that, under the doctrine of primary jurisdiction, and in deference to the FDA, the court should abstain from proceeding in the matter.

In denying Gerber’s motion, the court described the history of the FDA’s review of, and communications with, Gerber related to the health claims at issue.  This history included the FDA’s rejection of a qualified health claim proposed by Gerber in 2005, a subsequent petition by Gerber followed by an FDA letter of Enforcement Discretion in 2011, and a warning letter to Gerber regarding the marketing and branding of Good Start Gentle in 2014.  Just prior to the FDA issuing its warning letter, the Federal Trade Commission sued Gerber in connection with its advertising, marketing, and sale of Good Start Gentle in the District of New Jersey.

In light of these facts, Gerber argued that dismissal or abstention was warranted based on the doctrine of primary jurisdiction because there was a need for FDA expertise in the evaluation of health claims made in product labeling, and because “the FDA is currently considering certain of Gerber’s claims regarding Good Start.” (Opinion at 8 (citing Defendant’s Reply brief).  The court disagreed:

“The primary jurisdiction doctrine does not warrant the stay or dismissal of Plaintiff’s claims.  Plaintiff raises neither an issue of first impression nor a complex one.  Instead, her claims turn on whether Defendant’s representations concerning the health benefits of Good Start Gentle and the FDA’s approval of the formula were false or misleading.” (Opinion at 7).

The court found that the possibility that the factfinder would be required to consider evidence about clinical studies and those evaluated by the FDA was not a sufficient basis to apply the primary jurisdiction doctrine.  It also rejected the argument that allowing plaintiff’s claims to proceed would present a “substantial danger of inconsistent rulings,” because the FDA’s October 13, 2014 Warning Letter reiterated the findings of its 2011 determination, which was based on medical evidence available at the time it was made.  The claims currently under consideration by the agency “relate to milk allergies and the distinction between whey and whey protein,” which, in the court’s view, were not material to plaintiffs’ class action claims (Opinion at 8).

Although the FDA was involved in reviewing issues related to Gerber’s health claims for many years prior to commencement of this action, the court’s opinion emphasizes that the primary jurisdiction doctrine may be invoked only in limited circumstances.  Based on precedent in the consumer class action context, it is not surprising that the court found itself competent to address what it viewed as the core issue: whether a reasonable consumer would be misled by Gerber’s advertising.  However, as the opinion even suggests, cases such as this require that the parties be prepared to present substantial and potentially complex evidence regarding the relevant administrative history, including clinical studies, to the jury.

City of Denton, Texas, Repeals Its “Fracking” Ban

June 23, 2015

As we previously reported here at the Monitor, the City of Denton, Texas made headlines last year when it became the first municipality in Texas to ban hydraulic fracturing, or “fracking.”  Almost immediately after the bill’s passage, the Texas Oil and Gas Association filed a lawsuit challenging the ordinance.  In addition, the Texas General Land Office filed […]

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Northern District of California Dismisses FCA Claims Against Pharmaceutical Company

June 19, 2015

The Northern District of California recently dismissed for a second time a complaint brought against Gilead Sciences, Inc. that alleged, in part, that Gilead violated the False Claims Act, 31 U.S.C. § 3729 (“FCA”), by submitting or causing to be submitted false claims for payment to the Government under Medicare and Medicaid programs.  See United […]

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