Archives: Off-Label Use

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Off-Label Promotion And The First Amendment Updates

Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist. The FDA has announced a two-day public hearing on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”  In-person … Continue Reading

A Proposed End to “Amarin Pharm v. FDA” has FDA Agreeing to Abide by District Court’s Order

We have been closely following Amarin Pharm, Inc. v. FDA with respect to the preliminary injunction granted by the Southern District of New York that prohibited the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug Vascepa. We’ve also been following the similar Pacira Pharm., Inc. v. FDA case, which … Continue Reading

UPDATE: Pacira Pharmaceutical Inc. v. FDA Lawsuit Settled

The Pacira Pharmaceutical Inc. v. FDA lawsuit has been a frequent topic of discussion on the blog, and now, in breaking news, the case has been settled.  Pacira will be receiving essentially everything it wanted in a “favorable resolution,” and the FDA is formally withdrawing its warning letter that attempted a retroactive reduction in the … Continue Reading

Updates Regarding the Pacira Pharmaceutical Inc. v. FDA Lawsuit Regarding First Amendment and Off-Label Promotion Issues

As readers of this blog know, following Amarin’s success in obtaining a preliminary injunction limiting FDA enforcement action against it for truthful, non-misleading off-label promotion of its prescription drug Vascepa, Pacira Pharmaceuticals filed a similar lawsuit regarding off-label promotion of its prescription drug Exparel. While we await the FDA’s response to Pacira’s motion for preliminary … Continue Reading

Change Coming to FDA’s “Intended Use” Regulations?

Over at the Drug And Device Law Blog, our colleagues call attention to proposed changes to the “intended use” regulations for prescription drugs and devices, 21 C.F.R. §201.128 and 21 C.F.R. §804.1, somewhat hidden within a proposed rule regarding tobacco published in the Federal Register on September 25, 2015. As the FDA explained, the changes … Continue Reading

First Amarin Pharm v. FDA, Now Pacira Pharm, Inc. v. FDA

The Southern District of New York certainly is becoming a hotbed for issues relating to the FDA’s ability to take enforcement action against manufacturers who promote their FDA-regulated products for uses outside the approved label indications.  The Amarin Pharm v. FDA litigation has garnered a good deal of attention, and after Amarin and the FDA … Continue Reading

What Comes Next In Amarin Pharm v. FDA?

The Southern District of New York’s preliminary injunction in Amarin Pharm, Inc. v. FDA—prohibiting the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug Vascepa—understandably has been big news, analyzed here  and  elsewhere. Some are asking whether the FDA will pursue appellate review of the decision.  An indication about … Continue Reading

Amarin Obtains Preliminary Injunction Against FDA Regarding Off-Label and First Amendment Issues

In our prior posts about Amarin Pharma, Inc. v. FDA, we wondered what the Southern District of New York would make of Amarin’s request for an order prohibiting the FDA from taking enforcement actions against it over speech regarding “off-label” uses of its prescription drug, Vascepa.  Although Vascepa is regulated as a drug, equivalent products … Continue Reading

Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment

Our prior  posts  looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses.  We provided links to amicus briefs by the Pharmaceutical Research and Manufacturers of America and the Washington … Continue Reading

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses.  As we noted, on June 8, 2015, … Continue Reading

FDA Sued By Drug Manufacturer Over Constitutional Right To Discuss Off-Label Uses

The FDA has long sought to ban manufacturers from promoting off-label uses of approved drugs and medical devices.  In taking the position that manufacturers and their agents cannot promote off-label uses, the FDA suggests they are safeguarding the public from misbranded medical products and ensuring that manufacturers do not circumvent the drug- and device-approval processes. … Continue Reading

Proposed 21st Century Cures Act Addresses Off-Label Promotion Issues for Drugs and Devices

Over on the Health Industry Washington Watch blog, Reed Smith attorneys Katie Pawlitz and Jeremy Alexander highlight the proposed changes to the Sunshine Act contained within H.R. 6, the “21st Century Cures Act,” which (as previously reported on Life Sciences Legal Update) was approved by the House Energy and Commerce Committee last Thursday, May 21, … Continue Reading

New Jersey Appropriations Committee Approves Off-Label Drug Coverage Legislation

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.… Continue Reading

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

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...… Continue Reading

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 explained 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.… Continue Reading

“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 http://druganddevicelaw.blogspot.com) 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.… Continue Reading

Commentary: FDA’s New Good Reprint Practice Rule

Recent posts on www.lifescienceslegalupdate.com include: "Commentary: FDA's New Good Reprint Practice Rule". The Food and Drug Administration's new Good Reprint Practice ("GRP") Guidance went into effect 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. http://www.lifescienceslegalupdate.com/2009/01/articles/regulatory-developments/commentary-fdas-new-good-reprint-practice-rule/ ...and "Dept. of Bad Ideas: Criminalization of Product Liability" regarding the 2006 proposal by Senator Arlen Specter (R.-PA) to criminalize aspects of product liability law. http://www.lifescienceslegalupdate.com/2009/01/articles/product-liability/dept-of-bad-ideas-criminalization-of-product-liability/… Continue Reading

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

Recent posts on www.lifescienceslegalupdate.com include: "Current Issues Under The Civil False Claims Act: Worthless Services, Off-Label Use, and More" which 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). http://www.lifescienceslegalupdate.com/2009/01/articles/product-liability/offlabel-use/current-issues-under-the-civil-false-claims-act-worthless-services-offlabel-use-and-more/ ...and "Life Sciences Industry Members Who Contract With Government Should Note Recent Amendment to the Federal Acquisition Regulation" which discusses an amendment to the Federal Acquisition Regulation ("FAR") to establish: (1) mandatory disclosure requirements for certain violations of federal criminal law and the False Claims Act; (2) requirements for contractors to establish and maintain specific internal controls to detect, prevent, and disclose improper conduct in connection with the award or performance of any government contract or subcontract; and (3) new causes for suspension and debarment. See 73 Fed. Reg. 219, 67,064 (Nov. 12, 2008). http://www.lifescienceslegalupdate.com/2009/01/articles/regulatory-developments/life-sciences-industry-members-who-contract-with-government-should-note-recent-amendment-to-the-federal-acquisition-regulation/… Continue Reading

Review Of Final FDA Guidance On Off-Label Use Publications

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 [www.lifescienceslegalupdate.com/wp-content/uploads/sites/500/2015/05/alert09007.pdf] to read the full alert, which highlights these clarifications and provides an overview of the final guidance.… Continue Reading

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 … Continue Reading
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