The Irish drug manufacturer Amarin, has filed a lawsuit seeking to limit the powers of the Food and Drug Administration (FDA) in prohibiting so called “off label” promotion of uses of drugs. The FDA gives approval of specific uses of drugs after reviewing the proper testing data submitted by the drug companies. That approval is the “on label” use allowed. However, many drug companies promote and sell their drugs to physicians for different uses. The lawsuit seeks to have a federal court rule that the FDA prohibitions of off-label promotion violates the company’s First Amendment rights and that its sales representatives should be able to convey off label uses to doctors.
Amarin filed the suit after the FDA denied the company the right to sell its prescription fish-oil pill Vascepa to individuals who do not have very high levels of triglycerides, a fat in the blood which can lead to heart disease. Presently the oil is allowed to be marketed only to individuals with very high levels of triglycerides. The pharmaceutical companies want more freedom to promote their products without constraint. Patient advocates say that this would undermine the drug-approval process and essentially allow the companies to go around the FDA.
The issue of off –label drug promotion is a problem with wide scale dimensions involving billions of dollars to the drug manufacturers. In November 2013, John & Johnson paid $1,391 Billion to settle a False Claims Act case for its off-label promotion of Risperdal, Invega and Natrecor. Risperdal had been approved only to treat schizophrenia by Janssen, a Johnson and Johnson subsidiary promoted it to physicians to treat elderly dementia patients for symptoms such as anxiety, agitation, depression and confusion.
In July 2012, GlaxoSmithKline (GSK) paid $1.043 Billion to settle a False Claims Act case for its off lable promotion and sales of the drugs Paxil and Wellbutrin. It also promoted Lamictal an anti-epileptic medication for off-label, non covered psychiatric uses, neurpathic pain and pain management. In May 2004, Warner-Lambert agreed to pay $430 million to resolve civil and criminal liability in False Claims lawsuits for promotion of the epilepsy drug Neurontin for uses not approved by the FDA. Pfizer and other companies eventually paid more than $7 billion. The suit alleged that Parke-Davis had used fraudulent scientific evidence which was supported by tens of thousands of payments to doctors for “consultations” and “studies” to encourage them to prescribe the drug for conditions including migraines, bipolar disorder and attention deficit disorder even though it had been approved for use only as adjunctive treatment in patients with partial seizures and postherpetic neuralgia.
Jeffrey Newman represents whistleblowers