FDA Settles with Amarin in Off-Label Promotion Free Speech Lawsuit

Jordan Lipp, Esq. | Partner, Davis Graham & Stubb

As discussed more in an earlier post, Amarin Pharma sued the FDA in May 2015 asserting that under the First Amendment’s free speech protections, it could engage in truthful and non-misleading speech promoting the off-label use of its drug, Vascepa, for the treatment of patients with persistently high triglyceride levels.  On August 7, 2015, a federal judge in New York granted Amarin’s preliminary injunction in the case, and held that under the First Amendment’s free speech protections, the FDA could not bring a misbranding action against Amarin for Amarin’s off-label promotion.  As the Court stated:  “Where the speech at issue consists of truthful and non-misleading speech promoting the off-label use of an FDA-approved drug, such speech . . . cannot be the act upon which an action for misbranding is based.”

Yesterday, Amarin and the FDA settled this lawsuit.  The settlement largely mirrors the Court’s preliminary injunction order – with the FDA agreeing “to be bound by the Court’s conclusions that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa®,” and Amarin agreeing that it “bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa® remain truthful and non-misleading.”  The settlement also sets forth a preclearance procedure between Amarin and the FDA on other future off-label promotion of Vascepa.

This settlement cements Amarin’s victory on its preliminary injunction.  The course of this lawsuit has provided a roadmap for drug and device manufacturers looking to promote their products off-label – in terms of how to raise such promotional plans with the courts to obtain court approval and FDA agreement on such off-label promotion.

What Scalia’s Passing Means to Life Sciences Companies

Courtney A. Stevens | Senior Attorney, Loss Control | Medmarc Insurance Group

The recent passing of Justice Antonin Scalia, the Court’s longest-serving justice, means more than just political scuttlebutt over who will get to appoint his replacement. For life sciences companies, it means the loss of a real ally in matters of tort liability and a powerful force in intellectual property.

Preemption

Scalia authored the 8-1 majority opinion in Riegel v. Medtronic, 552 U.S. 312 (2008), a pivotal decision in preemption jurisprudence that held that the Medical Device Amendments to the Food, Drug and Cosmetic Act (FDCA) preempted state-law claims relating to the safety and effectiveness of pre-market approval (PMA) devices. This effectively shields makers of PMA devices from products liability claims.

In Wyeth v. Levine, 555 U.S. 555 (2009), which undermined preemption in holding that FDA approval of a medication does not preempt state law failure-to-warn claims, Scalia joined the dissent (authored by Justice Samuel Alito). The dissent argued that this holding was inconsistent with their previously-adopted “conflict preemption” analysis.

Continue reading “What Scalia’s Passing Means to Life Sciences Companies”

FDA Issues Draft Guidance: Postmarket Cybersecurity for Medical Devices

Jordan Lipp | Partner Davis Graham & Stubbs LLP

A little over a year after issuing final guidance on premarket submissions for management of cybersecurity in medical devices, discussed here, the FDA issued draft guidance on postmarket cybersecurity (available here).  The FDA’s stated purpose of this draft guidance, which it just issued, is to clarify “FDA’s postmarket recommendations and [to] emphasizes that manufacturers should monitor, identify and address cybersecurity vulnerabilities and exploits as part of their postmarket management of medical devices.”  As cybersecurity threats are continually evolving, the FDA explains that it is not possible to completely mitigate cybersecurity risks solely through premarket controls.  Recognizing that “medical device cybersecurity is a shared responsibility between stakeholders,” the draft guidance addresses both risk management and remediation of cybersecurity threats.  It also discusses the interplay of cybersecurity issues and medical device companies’ reporting requirements, setting forth several examples of what should or should not be reported. Continue reading “FDA Issues Draft Guidance: Postmarket Cybersecurity for Medical Devices”

Regulatory Roundup: FDA Reports and Guidances in August

Courtney A. Stevens, Esq. | Senior Attorney, Medmarc Loss Control

Recommendations for a National Medical Device Evaluation System

On August 20, the FDA released, for public comment, a report from the Medical Device Registry Task Force and the Medical Devices FDA logo.jpgEpidemiology Network. The report described the inadequacies in the existing framework for medical device evaluation, what a more effective system would look like, what devices would be particularly ripe for evaluation via such a system, and how the system could be implemented. The full report can be found here.

FDA Issued Several New Drug and Device Guidances

The Agency issued several new guidance documents in August, including the following. Continue reading “Regulatory Roundup: FDA Reports and Guidances in August”

FDA Reopens Comment Period on Generic Drug Labeling Proposed Rule

Jordan L. Lipp | Partner, Davis Graham & Stubbs LLP

Bowing to pressure from stakeholders and Congress, on Tuesday FDA announced that it would reopen the comment period (through April 27, 2015) for its proposed rule that would allow generic drug manufacturers to unilaterally change their labels.  And, FDA set a public meeting for March 27, 2015, in order to “provide a public forum for FDA to listen to comments on the proposed rule.”  As discussed in more depth in an earlier post, FDA’s highly controversial proposed rule would permit generic drug manufacturers to unilaterally change their labels under changes-being-effected (“CBE”) process, which not only would result in the potential for generic and brand-name labels to differ, but would also threaten to undermine recent generic drug preemption decisions by the U.S. Supreme Court. Continue reading “FDA Reopens Comment Period on Generic Drug Labeling Proposed Rule”

FDA Issues Draft Guidance on General Wellness Products

Courtney A. Stevens, Esq. | Senior Attorney, Medmarc Loss Control

On Friday, January 16, the Food and Drug Administration published two draft guidances pursuant to its FDASIA-mandated Health IT Report, released in April of last year: (1) General Wellness: Policy for Low Risk Devices; and (2) Medical Device Accessories: Defining Accessories and Classification Pathways for New Accessory Types. This post discusses the first.

General Wellness Products

The first draft guidance, General Wellness: Policy for Low Risk Devices, does very little in the way of policy. Rather, the majority of the Guidance is devoted to defining what general wellness products are and helping industry determine whether their devices fall under this policy. Continue reading “FDA Issues Draft Guidance on General Wellness Products”