First Amendment, False Claims, and Off-Label Promotion Allegations

The Drug & Device Law blog recently posted an analysis of an interesting case, United States ex rel. Solis v. Millennium Pharmaceuticals, Inc., that takes an issue the government has fought in the past – off-label promotion – and attempts to provide a link between it and the false claims issues that relators bring under the government’s name. Solis asserts that the dissemination of certain published medical articles on the part of the defendant constituted off-label promotion and resulted in the submission of false claims for federal reimbursement.

As Reed Smith partner Jim Beck discusses in his post, False Claims Act (FCA) litigation may provide drug and medical device counsel with ample opportunity to cite the First Amendment as a means of defense. The defense in Solis – supported in an amicus curiae brief filed by the Pharmaceutical Research and Manufacturers of America– argues that the dissemination of the medical articles was not “false” in that it did not present incorrect or misleading information, was protected by First Amendment, and did not lead to the submission of any false claims.

New Jersey Appropriations Committee Approves Off-Label Drug Coverage Legislation

This post was written by Jennifer Pike.

On March 7, 2013, the New Jersey Assembly Appropriations Committee approved legislation related to off-label drug coverage. Assembly bill A1830 would require health benefits plans offered to individuals and small employers, the State Health Benefits Program (SHBP) and the School Employees’ Health Benefits Program (SEHBP), to provide coverage for certain off-label uses for drugs that are approved by the U.S. Food and Drug Administration. The health plans would be required to provide coverage for off-label use of a drug if the drug is recognized as being medically appropriate for the specific treatment for which is has been prescribed in one of two established reference compendia (the American Hospital Formulary Service Drug Information or the U.S. Pharmacopeia Drug Information), or if the drug is recommended by a clinical study or review article in a major peer-reviewed professional journal. According to bill sponsor Herb Conaway M.D., "the purpose of [the] bill is to extend the medical benefits that may derive from the use of off-label drugs to individuals who may not be able to access these medications. In particular those individuals who are suffering from a terminal or chronically debilitating illness, because their insurance carriers won’t cover these drugs.” The full text and status of the bill are available here.

"Illegal" Off-Label Promotion

Over at the Drug and Device Law Blog, there are several posts analyzing the meaning of the Second Circuit’s opinion in United States v. Caronia, 703 F.3d 149, 160 (2d Cir. 2012), including this one and this one.  Most Caronia commentary has focused on the court’s First Amendment holding, that the FDCA does not ban truthful off-label speech. But today’s Drug and Device Law Blog post zeroes in on the Second Circuit’s recognition that “[t]he FDCA and its accompanying regulations do not expressly prohibit the ‘promotion’ or ‘marketing’ of drugs for off-label use” (id. (emphasis added)), and what that may mean for regulation and for ancillary issues, like medical device preemption under 21 U.S.C. Section 360k(a).

FDA's Emerging Internet Policy: Themes and Recommendations From Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools

This post was written by Areta Kupchyk, Kevin Madagan, and Paul Sheives.

Following a decade-long hiatus, the Food and Drug Administration (“FDA”) appears ready to finally address industry Internet communications. FDA’s Center for Drug Evaluation and Research (“CDER”) in collaboration with other divisions within FDA, held a two-day hearing on November 12th and 13th to help the Agency determine how the statutory provisions, regulations, and policies governing advertising and promotional labeling should be applied to product-related information on the Internet and emerging technologies.

Much has changed since 1996, the last time FDA held a public hearing on this topic. The Internet is now widely used as a medium for companies to disseminate information about their products, and the Internet's ability to facilitate communication and collaboration has substantially evolved over the last few years primarily as a result of a second (Web 2.0) and now third (Web 3.0) generation of Internet development and website design. The inherent flexibility and intelligence of Web 2.0 and 3.0 is great for society, but also fraught with risk for an FDA-regulated industry that must carefully control its interactions with consumers and health care practitioners. Indeed, the industry has largely avoided using Web 2.0 out of fear that any social media use may result in FDA enforcement action. 

Given the above, it is not surprising that FDA’s hearing was a welcome relief to many. Even though the hearing technically was only an information gathering exercise for FDA, it was an important opportunity for industry leaders and stakeholders to contribute to FDA’s emerging Internet policy. This Client Alert provides a brief summary of the major themes and recommendations from the presenters at the hearing.

In addition, please see a related commentary on the blog Adlaw by Request (“FDA Seeks To Understand Social Media”). Adlaw by Request is a blog designed to provide regular news on advertising law developments in the United States and elsewhere, with practical commentary and analysis from Reed Smith’s Advertising, Technology and Media (ATM) practice.

Advertising of medicinal products versus freedom of expression of a journalist - European Court of Justice Decision dated 2 April 2009 (C-421/07) "Frede Damgaard"

The European Court of Justice ("ECJ") recently had the opportunity to opine on limits on the scope of advertising for medical products in the European Union, when a journalist who had reprinted factual information about a pain medication sold in Norway but prohibited in Denmark, was made an example under Danish legal provisions prohibiting advertising for medicinal products that are not lawfully marketed in Denmark. As exmplained by Paule Drouault-Gardrat, Julie Gottenberg and Juliette Peterka in "Advertising of medicinal products versus freedom of expression of a journalist - European Court of Justice Decision dated 2 April 2009 (C-421/07) 'Frede Damgaard' " (available also in French), the ECJ concluded the issue was a matter for the national court in the first instance, relying in part on a line of French cases holding that any publication praising the merits of a medicinal product must be considered as advertising whomever its author, regardless of whether the manufacturer sought or paid for publication.

"Off-Label" Uses Are Not Off-Standard

In a recent law journal article authored about FDA approved labels and off-label uses, authors Mark Herrmann (of the and Pearson Bownas demonstrate the folly of letting the standard of care in medical malpractice cases be defined by whether the doctor used a prescription product "on label" or "off label." The article succinctly explains how off-label use is a prevalent and necessary part of the practice of medicine, and that off label use is not and cannot be legally regulated by the FDA. Off label treatments are undeniably common, whether because manufacturers face prohibitive costs to obtain approval for certain uses when those uses are already accepted in the medical community, or because doctors are ethically obliged to provide the best treatment possible for their patients regardless of the indications for use approved by the FDA . Further, the authors point out that in many instances off-label use may be the standard of care for providing the "safest, most effective, state-of-the-art treatment." Thus, in light of the accepted and prevalent practice of off-label use, the authors point out that allowing FDA approved drug and device labels as "some evidence" of the standard of medical care should be outweighed by the significant risk of prejudice, confusion and time wasting that admission of evidence about the label indications for use would cause. Of relevance to the Life Sciences and Health Industry, the article provides a good overview of the reasons and authorities existing to mitigate the force of a product's label in failure-to-warn off-label use cases.

Commentary: FDA's New Good Reprint Practice Rule

This post was written by Areta L. Kupchyk, James M. Wood and Kevin M. Madagan.

FDA's Good Reprint Practice (GRP) Guidance went into effect in January 2009. The GRP Guidance establishes criteria that FDA will now use to determine whether the distribution of medical or scientific reprints and reference texts about off-label uses of a drug or device would constitute impermissible promotional activity under the Food, Drug and Cosmetic Act.

Read Reed Smith’s full commentary analyzing the GRP Guidance, which includes a Good Reprint Practice Checklist.

Current Issues Under The Civil False Claims Act: Worthless Services, Off-Label Use, and More

This post was written by Elizabeth Carder-Thompson and Andrew L. Hurst.

A dizzying array of civil and criminal provisions address false or fraudulent representations made to, and false claims filed with, Medicare, Medicaid, and state and federal health care programs. This attached article, first published by the American Health Lawyers Association, briefly identifies relevant criminal and civil provisions relating to these issues, and then focuses more closely on recent uses of the civil False Claims Act (“FCA”) in government investigations of health care providers, suppliers, and manufacturers, including a section on state false claims legislation. Finally, it discusses the issue of distinguishing overpayments from false claims and provide information on the voluntary disclosure program of the Office of the Inspector General (“OIG”) of the Department of Health and Human Services (HHS).

Review Of Final FDA Guidance On Off-Label Use Publications

This post was written by Areta L. Kupchyk, James M. Wood and Kevin Madagan.

On January 13, 2009, eleven months after the Food and Drug Administration (FDA) issued a draft guidance document, and 2 1/2 years after the sunset of the statute intended to permit the dissemination of medical literature about unapproved uses of drugs and medical devices, the FDA issued a final guideline for such dissemination. Often referred to as “the distribution of off-label use journal articles,” FDA’s final guidance is aptly named “Guidance For Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.”

As with the 2008 draft guidance, the final version begins by succinctly discussing the historical attempts to regulate the distribution of literature about unapproved uses, including noting the need to balance the law’s prohibition on distributing or promoting “unapproved uses of approved drugs and approved or cleared medical devices” with the “important public policy” of providing information that “may even constitute a medically recognized standard of care.” FDA concludes that the touchstone for lawful dissemination of literature about unapproved uses is that the publications “are truthful and non-misleading.”

To meet this standard, the FDA final guidance lists “principles of Good Reprint Practices” that include criteria for determining the type of publication, and the manner in which the publication can be distributed. Although the final guidance closely tracks the draft guidance, it has some important clarifications.

Click here to read the full alert, which highlights these clarifications and provides an overview of the final guidance.

UPDATE: Much obliged to Drug and Device Law for the link and thoughtful discussion, and more also is at the FDA Law Blog.

Medical Monitoring: Oregon Requires 'Present Physical Injury' - Or Does It?

This post was written by Peggy Sanner.

On May 1, 2008, in Lowe v. Philip Morris USA Inc., et al.1, the Oregon Supreme Court rejected a smoker’s bid to mount a medical monitoring class action against five cigarette manufacturers. The court concluded that the plaintiff’s admitted lack of any present physical injury doomed her negligence case.

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Review of Proposed FDA Guidance on Off-Label Use Publications

This post was written by Areta L. Kupchyk, James M. Wood, Joseph W. Metro, and Kevin M. Madagan.

On February 15, 2008, a year-and-a-half after the sunset of the statute (Section 401 of the Food and Drug Administration Modernization Act) intended to permit the dissemination of medical literature about unapproved uses of drugs and medical devices, the Food and Drug Administration (“FDA”) proposed a draft guideline for such dissemination. Often referred to as “the distribution of off-label use journal articles,” FDA has saddled the proposed guidelines with a much heftier title: “Guidance For Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.”

The FDA has invited comments—which must be submitted no later than April 14, 2008—on the draft guidance. Only after consideration of any comments will FDA move to finalize the draft guidance.

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