Tag Archives: First Amendment

FDA Delays “Intended Use” Final Rule until March 2018

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.

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Significant Court Decision Issued Today re: Off-Label Promotion

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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. 

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Case to Watch: Amarin Pharma v. FDA

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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.

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Constitutional Challenge to HIPAA

On September 6, 2013, Adheris, Inc. (“Adheris”), an inVentiv company that works with pharmacies and pharmaceutical manufacturers to send medication refill reminders and educational information regarding diseases to patients, filed suit against the U.S. Department of Health and Human Services (“HHS”).  Adheris alleges that certain provisions of the Final HIPAA Omnibus Rule (the “Omnibus Rule”) scheduled to go into effect on September 23, 2013 violate the First Amendment by hindering refill reminder services.  In support of its position, Adheris filed a Motion for a Preliminary Injunction that cites Sorrell vs. IMS Health, Inc., in which the Supreme Court affirmed that “speech in aid of pharmaceutical marketing…is a form of expression protected by the Free Speech Clause of the First Amendment.” Continue reading

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Filed under Health Information Privacy, HIPAA, HIPAA Omnibus Rule, HITECH Act, Privacy and Security