Marketing of off-label use

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Marketing of off-label use is advertising the use of drugs for purposes not approved by the regional government. The practice is often illegal and has led to most of the largest pharmaceutical settlements after Franklin v. Parke-Davis , in which a court ruled off-label marketing a violation of the False Claims Act.

Contents

List of off-label promotion pharmaceutical settlements

Many of the conflicts among the list of largest pharmaceutical settlements were because of off-label promotion.

Franklin v. Parke-Davis

In 1993, the FDA approved gabapentin, marketed by Pfizer under the name "Neurontin", only for treatment of seizures. Pfizer subsidiary Warner-Lambert illegally used scientific activities, including continuing medical education and research, to commercially promote gabapentin, so that within five years the drug was being widely used for the off-label treatment of pain and psychiatric conditions—conditions that had not been approved by FDA. In 2004, Warner-Lambert admitted to charges that it violated FDA regulations by promoting the drug for these off-label uses: pain, psychiatric conditions, migraine, and other unapproved uses. [1] The company paid $430 million to the federal government to settle the case. [2]

Marketing of off-label use

Access to pharmaceutical industry documents has revealed marketing strategies used to promote drugs for off-label use. [3] The United States federal government is aggressively pursuing criminal and civil cases against pharmaceutical companies and their employees for promoting off-label uses of prescription drugs. [4] Between 2003 and 2008, U.S. federal prosecutors and state attorneys general brought more than a dozen cases against drug manufacturers for off-label marketing and won more than $6 billion in criminal and civil settlements. [5] In September 2009, Pfizer paid $1.3 billion, the largest criminal fine ever imposed in the United States, for the off-label marketing of Bextra and three other drugs. Pfizer paid an additional $1 billion in civil penalties resulting from the same illegal activities. [6]

First Amendment issues

The FDA takes the position that a drug manufacturer may not promote its drug for an unapproved use, and that any such promotion is false and misleading simply because it is not FDA-approved. However, many off-label uses are in fact effective and safe, as is evidenced by subsequent FDA approval of such uses for numerous drug products. The Supreme Court has in recent years begun to address the boundaries between government regulation of pharmaceuticals and the First Amendment free speech guarantee. Some legal observers have suggested that the trend in the Court's decisions may ultimately reduce the ability of FDA to prevent broader dissemination of off-label information about approved drug products. [7]

A three-judge panel of the United States Court of Appeals for the Second Circuit in Manhattan ruled on December 5, 2012, that a drug sales representative who was criminally prosecuted for making off-label promotional statements about Xyrem had suffered a violation of his First Amendment right to freedom of speech. [8]

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<span class="mw-page-title-main">Pfizer</span> American multinational pharmaceutical and biotechnology corporation

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<span class="mw-page-title-main">Parke-Davis</span> Pfizer subsidiary

Parke-Davis is a subsidiary of the pharmaceutical company Pfizer. Although Parke, Davis & Co. is no longer an independent corporation, it was once America's oldest and largest drug maker, and played an important role in medical history. In 1970 Parke-Davis was acquired by Warner-Lambert, which in turn was acquired by Pfizer in 2000.

<span class="mw-page-title-main">Off-label use</span> Use of pharmaceuticals for conditions different from that for which they were approved

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Continuing medical education (CME) is continuing education (CE) that helps those in the medical field maintain competence and learn about new and developing areas of their field. These activities may take place as live events, written publications, online programs, audio, video, or other electronic media. Content for these programs is developed, reviewed, and delivered by faculty who are experts in their individual clinical areas. Similar to the process used in academic journals, any potentially conflicting financial relationships for faculty members must be both disclosed and resolved in a meaningful way. However, critics complain that drug and device manufacturers often use their financial sponsorship to bias CMEs towards marketing their own products.

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<span class="mw-page-title-main">Peter Rost (doctor)</span>

Peter Rost is an American former drug marketing executive who is most known for taking public stances critical of the pharmaceutical industry as an "insider" and whistleblower. He sued his last two pharmaceutical employers, Wyeth and Pfizer, the latter of which fired him in 2005. At Wyeth, he uncovered tax evasion practices, and after informing senior company executives, was transferred from Sweden to a post in New Jersey. Rost sued the company, saying that the transfer was a retaliatory demotion, though the company said it was a promotion. Rost settled with Wyeth for an undisclosed amount in 2003. At Pfizer, Rost filed a qui tam suit disclosing off-label marketing of Genotropin at Pharmacia prior to its purchase by Pfizer. The U.S. Department of Justice declined to join in Rost's suit as the marketing violations had already been disclosed to the Department by Pfizer. Rost was eventually fired by Pfizer, and sued for wrongful dismissal, but this lawsuit was summarily dismissed by the court based on evidence that Pfizer had decided to fire Rost prior to discovery of his whistleblowing activities. Since then, Rost has worked outside the pharmaceutical industry, as a public speaker, blogger, writer, and litigation consultant.

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David Franklin is an American microbiologist and former fellow of Harvard Medical School who while employed by Parke-Davis filed the 1996 whistleblower lawsuit exposing their illegal promotion of Neurontin (gabapentin) for off-label uses. Franklin's suit, filed on behalf of the citizens of the United States under the qui tam provisions of US federal and state law, uncovered illegal pharmaceutical industry practices and created new legal precedent that resulted in a cascade of criminal convictions and civil and criminal penalties against Pfizer and several other pharmaceutical companies totalling more than $7 billion. Civil cases also followed Franklin v. Parke-Davis. Insurance companies, led by Kaiser Permanente, sued Pfizer for fraud and violation of the federal Racketeer Influenced and Corrupt Organizations Act; the Kaiser case settled in April 2014 after Pfizer's appeal at the US Supreme Court was rejected. Franklin v. Pfizer also spawned more than a thousand wrongful death (suicide) suits associated with use of Neurontin. Numerous books have addressed the social, economic and healthcare implications of Dr. Franklin's stance and actions. The settlement was the first off-label promotion settlement under the False Claims Act.

<span class="mw-page-title-main">Wyeth</span> American pharmaceutical company

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Pharmaceutical fraud involves activities that result in false claims to insurers or programs such as Medicare in the United States or equivalent state programs for financial gain to a pharmaceutical company. There are several different schemes used to defraud the health care system which are particular to the pharmaceutical industry. These include: Good Manufacturing Practice (GMP) Violations, Off Label Marketing, Best Price Fraud, CME Fraud, Medicaid Price Reporting, and Manufactured Compound Drugs. Examples of fraud cases include the GlaxoSmithKline $3 billion settlement, Pfizer $2.3 billion settlement, and Merck $650 million settlement. Damages from fraud can be recovered by use of the False Claims Act, most commonly under the qui tam provisions which rewards an individual for being a "whistleblower", or relator (law).

<i>Franklin v. Parke-Davis</i>

Franklin v. Parke-Davis is a lawsuit filed in 1996 against Parke-Davis, a division of Warner-Lambert Company, and eventually against Pfizer under the qui tam provisions of the False Claims Act. The suit was commenced by David Franklin, a microbiologist hired in the spring of 1996 in a sales capacity at Parke-Davis, a pharmaceutical subsidiary of Warner-Lambert. In denying the defendants' motion for summary judgment, the court for the first time recognized off-label promotion of drugs could cause Medicaid to pay for prescriptions that were not reimbursable, triggering False Claims Act liability. The case was also significant in exposing the degree to which publication bias impacts the randomized controlled studies conducted by pharmaceutical companies to test the efficacy of their products. Ultimately, the parties reached a settlement agreement of $430 million to resolve all civil claims and criminal charges stemming from the qui tam complaint. At the time of the settlement in May 2004, it represented one of the largest False Claims Act recoveries against a pharmaceutical company in U.S. history, and was the first off-label promotion settlement under the False Claims Act.

The STEPS trial was a clinical trial sponsored by Parke-Davis to evaluate the anticonvulsant Neurontin. It is notable for being a seeding trial to promote that drug and for contributing to the drug companies loss in the court case Franklin v. Parke-Davis.

References

  1. ↑ Jane E. Henney, MD (15 August 2006). "Editorial: safeguarding patient welfare: who's in charge?". Annals of Internal Medicine. 145 (4): 305–307. doi:10.7326/0003-4819-145-4-200608150-00013. PMID   16908923. S2CID   39262014.
  2. ↑ US Department of Justice Press Release: Warner-Lambert to Pay $430 Million to Resolve Criminal & Civil Health Care Liability Relating to Off-Label Promotion, retrieved 14 August 2006
  3. ↑ Michael A. Steinman, MD; Lisa A. Bero; Mary-Margaret Chren, MD & C. Seth Landefeld, MD (15 August 2006). "Narrative review: the promotion of gabapentin: an analysis of internal industry documents". Annals of Internal Medicine. 145 (4): 284–293. doi:10.7326/0003-4819-145-4-200608150-00008. PMID   16908919. S2CID   20779923.
  4. ↑ Erika Kelton, "Sales tactics, whistleblowers and qui tam lawsuits in the pharmaceutical industry" Archived 2007-01-04 at the Wayback Machine
  5. ↑ Chris Adams (February 1, 2009). "Late move on drugs by Bush FDA could be dangerous". McClatchy Newspapers. Archived from the original on February 3, 2009.
  6. ↑ Archived September 5, 2009, at the Wayback Machine
  7. ↑ "Government Regulation of Commercial Speech After Sorrell v. IMS Health, Inc". www.wileyrein.com. Archived from the original (PDF) on 2011-11-26. Retrieved 2012-12-12.
  8. ↑ "Off-Label Drug Marketing Is 'Free Speech,' Court Rules". ABC News. Retrieved 10 December 2012.
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