The Dangers Of Information Restrictions On Drugs’ Off-Label Uses - On the Docket - Inside the courtroom - Forbes
Connotea Imports 2012-07-31
Summary:
"Federal policy — in the form of Food & Drug Administration regulation and Department of Justice enforcement actions — deeply frustrates medical professionals’ ability to receive truthful studies and other information about the so-called off-label use of drugs and devices. “Off-label” use — essentially any use of a treatment which does not appear on the product’s “label” — is lawful, common, and in fact constitutes the standard of care in practices such as oncology and pediatrics. For 20 years, federal health and justice officials have concocted and applied a warped set of legal principles which essentially prohibit medical product makers from sharing truthful information (even peer-reviewed journal articles) with doctors about off-label uses. Washington Legal Foundation has fought this policy in the courts and at FDA and DOJ for nearly two decades...."