New Lawsuit Chips Away at FDA’s Unwritten Off-Label Rules


Par Pharmaceutical, Inc. filed suit on October 14, 2011 to curtail prosecutions for off-label promotion based solely upon the physician specialties to which pharmaceutical manufacturers market their products.  In short, Par wants to promote its AIDS-related wasting drug, Megace ES®, for on-label uses but to physician specialties in long-term care and oncology settings that would likely use it predominantly for off-label indications.

FDA’s prior off-label promotion cases against pharmaceutical manufacturers have included allegations that a manufacturer’s promotion of a product to a physician more likely to prescribe the product for an off-label use than an on-label use demonstrated that manufacturer’s intent to encourage the off-label use of its product.  The question Par is asking the courts to consider is, should the manufacturer be responsible for physicians’ decisions if they can demonstrate intent to market on-label?

Free Speech

Physicians are legally allowed, based on their expert medical judgment, to prescribe drugs for off-label.

For example, in its complaint against Eli Lilly related to its promotion of Zyprexa®, the government’s allegations of off-label promotion included allegations that the company promoted the drug approved for schizophrenia in long-term care facilities where the incidence of schizophrenia is low. As a result, many pharmaceutical and medical device manufacturers tightly control the list of physicians their sales representatives may call on, and otherwise seek to avoid promotion of even on-label uses of their products to customers who are unlikely to use the product on-label.

Here are the key elements of Par’s complaint:

  1. Specifically, Par seeks a declaratory judgment that FDA’s prohibition against promotion of the on-label uses of its AIDS-related wasting drug Megace ES® to physicians practicing in oncology and in long-term care settings violates the First Amendment.  Par also seeks a preliminary injunction prohibiting the United States from prosecuting the company or its executives for these activities.
  2. Par alleges that the threat of criminal prosecution for misbranding or sale of an unapproved new drug has chilled its permissible speech regarding the on-label uses of Megace ES®.
  3. Par’s complaint seeks a declaratory judgment and injunction against prosecution for any of its intended speech, as described in the complaint, that the government deems to be off-label.
  4. It also asserts that the expansive definition of “labeling” in the prescription drug advertising regulations to include oral communications by sales representatives is overly broad, violates the First Amendment, and is invalid as a matter of statutory construction because it is more expansive than the definition set forth in the Federal Food, Drug and Cosmetic Act.

Par’s final assertion that oral communications by sales representatives should not constitute product labeling will hopefully create, along with their other complaints, a judicial dialogue that provides insights and clarity which chip away at FDA’s unwritten off-label rules.

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2 responses to “New Lawsuit Chips Away at FDA’s Unwritten Off-Label Rules

  1. Pingback: 2012 Digital Trends for Medical Marketing (Sales and iPads too) | Good Promotional Practices

  2. Pingback: 2012 Digital Trends for Healthcare Marketing slideshow | Good Promotional Practices

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