Late last week, the U.S. Food and Drug Administration (FDA) announced that it was once again delaying implementation of the final rule issued January 9, 2017 related to amendments to its regulations regarding intended use (Final Rule). This implementation delay follows a Petition to Stay and for Reconsideration (Petition) filed February 8, 2017 by the Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Biotechnology Innovation Organization (BIO). The Petition argued that the Final Rule’s inclusion of a “totality of the evidence” standard is a new standard not found in the Food, Drug, and Cosmetic Act (FDCA) or case law related to intended use and was promulgated in violation in the APA because parties subject to this significant liability standard did not receive fair notice or a meaningful opportunity to comment.
Tag Archives: off-label
A notice was published today in the Federal Register regarding a two day public hearing that will be held on November 9-10, 2016 by the U.S. Food and Drug Administration (FDA) to obtain input from a wide range of stakeholders regarding communications by industry related to unapproved uses of FDA-regulated drugs, biological products and medical devices (collectively, “Medical Products”). The announcement noted that FDA has been engaged in a comprehensive review of its regulations and policies related to off-label communications of approved or cleared Medical Products since 2014, and input from the meeting will further inform FDA’s policy development.
As Washington speeds towards Election Day on November 8th, it is a good time to examine the status of the key legislative and policy issues impacting the healthcare and life sciences sectors. Congress has few legislative working days remaining in 2016, but could make some headway on legislation to promote innovation as well as prevent certain rulemakings like the Medicare Part B demonstration project. In addition to closing out existing priories, Congress will turn its attention to new and recurring issues such as increasing the amount of generic drugs. Here is an overview of what’s left to be done this year during the “lame duck” session that begins in mid-November and what is on the horizon for 2017.
In the wake of Amarin Pharma’s victory in securing a preliminary injunction against the Food and Drug Administration’s (FDA) prohibition of off-label communication of Vacepa , Pacira Pharmaceuticals has filed a First Amendment challenge to the FDA’s attempt to restrict communications about its postsurgical pain drug, Exparel. Pacira’ s lawsuit, filed in the U.S. District Court for the Southern District of New York, argues that the FDA’s restriction on promotion of Exparel for a range of surgeries violates its First Amendment rights by abridging its “truthful and non-misleading speech.” The genesis of the dispute is a September 2014 warning letter from the FDA that told Pacira to stop promoting Exparel for use in any surgeries other than the two for which it was approved, bunionectomies or hemorrhiodectomies.
What makes the Pacira lawsuit interesting is that is not solely focused on off-label restrictions, which were the core of the Amarin case. It also alleges violations of free speech for prohibiting the sharing truthful and non-misleading information with “sophisticated audiences” about use of Exparel in other surgical sites, its ability to control pain for up to 72 hours and its comparative effectiveness to other products. Some commentators, such as the Collation for Healthcare Communication, claim that “the Pacira complaint may be even more compelling [than Amarin] because it challenges under the First Amendment many traditional theories that the FDA’s Office of Prescription Drug Promotion [OPDP] has used to regulate marketing.” These two cases could signal a trend toward companies becoming more willing to aggressively challenge the FDA when it comes to promotional issues. We continue to watch how the FDA responds and whether Congress will take up the issue as it debates comprehensive biomedical reform in the 21st Century Cures and Innovation for Healthier Americans legislative initiatives.
In addition to the First Amendment claim, the Pacira lawsuit alleges that the FDA violated the Administrative Procedure Act, the Fifth Amendment, as well as its own guidance materials and prior precedent. The full library of Pacira’s materials is available here: http://phx.corporate-ir.net/phoenix.zhtml?c=220759&p=irol-lawsuit
A highly anticipated decision was issued today in the U.S. District Court for the Southern District of New York in the case, Amarin Pharma Inc. et al. v. Food and Drug Administration et al. (case no. 1:15-cv-03588). See this blog post for additional background on the case.
In a detailed 69-page decision, the Court granted Amarin’s motion for a preliminary injunction, holding that the statements and disclosures proposed by Amarin are truthful and not misleading, and thus may not form the basis for a prosecution based on misbranding. Relying heavily on United States v. Caronia in its analysis, the Court stated that “Amarin has established a substantial likelihood of success on the merits” related to its “First Amendment right to be free from a misbranding action based on truthful speech promoting the off-label use of an FDA-approved drug.” However, the Court makes it clear that Caronia “leaves room for prosecuting off-label marketing as misbranding”, such as situations were a manufacturer uses false or misleading commercial communications or engages in “non-communicative activities” to promote an off-label use.
We will continue to monitor this important case and report significant developments.
This week, a federal district court denied Cephalon Inc.’s (Cephalon) motion to dismiss a third amended complaint filed under the False Claims Act (FCA) by three qui tam relators in United States ex rel. Boise v. Cephalon, Inc. The motion to dismiss relates to claims made by the whistleblowers under 31 U.S.C.§ 3729(a)(1)(G) (“. . . knowingly makes, uses, or causes to be made or used, a false record or statement material to an obligation to pay or transmit money or property to the Government, or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit money or property to the Government . . .”). Specifically, the relators allege that Cephalon promoted its drugs Provigil and Nuvigil for off-label purposes and paid unlawful kickbacks to health care professionals, and failed to report this conduct in violation of its 2008 corporate integrity agreement (CIA) with the U.S. Department of Health and Human Services Office of Inspector General (OIG).
A potentially significant case being watched by the pharmaceutical industry is Amarin Pharma, et al., v. U.S. Food and Drug Administration, et al., Civ. A. 15-cv-3588 (S.D.N.Y.). The complaint, filed in May 2015, is a “First Amendment challenge to FDA regulations that prohibit Amarin, a pharmaceutical company, from making completely truthful and non-misleading statements about its product to sophisticated healthcare professionals” (HCPs), including the HCP plaintiffs. Although Amarin’s drug Vascepa® is FDA-approved to treat adult patients with severe hypertriglyceridemia, the FDA recently denied Amarin’s supplemental new drug application (sNDA) to expand the Vascepa indication to include patients with high triglycerides, consistent with the patient population in its ANCHOR clinical trial. Citing United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), Amarin is asking the Court to “hold that FDA’s prohibitions on ‘off-label’ promotion, as applied to the truthful and non-misleading speech Amarin wishes to make, are unconstitutional under the First Amendment, and to declare that Amarin may engage in its proposed speech about Vascepa.”
In an interesting move, on June 8, 2015, the FDA filed with the Court a letter that it issued to Amarin on June 5, 2015, which states that the “FDA does not have concerns with much of the information that you proposed to communicate.” The letter further notes that Amarin did not discuss the matter with the FDA prior to filings it complaint, “as other pharmaceutical companies do”, nor during its discussions with the FDA over many years related to the labeling of Vascepa. The FDA also states that it currently is engaged in a “comprehensive review of its regulations and guidance documents” related to the dissemination of production information and that “new guidance will be forthcoming.”
It appears that the FDA’s letter was a pre-emptive move to undermine Amarin’s lawsuit. We will continue to watch this important case.