Legal Analysis: A Low Dose Prescription

December 10, 2007

Criminal Prosecution of Off-Label Drug Promotion

Excerpt:

Drug company scientists discover that a rare debilitating disease may be treated with a drug licensed to treat an unrelated ailment. The Food and Drug Administration (“FDA”) has not approved the drug for the rare disease. While the company begins time consuming and expensive clinical trials to test this discovery, patients with the rare disease ask their doctor for the drug. Doctors seek as much information as possible on this “off-label” use. The drug company wants to get the word out quickly about the new use.

  • Should a drug company be permitted to promote the drug for the new use before FDA approval, and if so, what can the company say?
  • Should doctors be permitted to prescribe a drug for an unapproved use, and if so, under what conditions?
  • If doctors can prescribe the drug, how do they obtain information on the correct dosage and adverse side effects?
  • Under what circumstances can a company provide “off-label” information to doctors?

Download A Low Dose Prescription: Criminal Prosecution of Off-Label Drug Promotion (.pdf)