An incalculable amount of time, money, and effort have been invested recently to purportedly improve American patients’ health care.  But nothing has been done to address a federal policy which undermines a basic, fundamental need of physicians, which, in turn, has a direct impact on patients: access to the latest and best information on medical treatments. 

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.

We are pleased to see some of this work reflected in an important new law review article authored by former Cephalon, Inc. Executive Vice President and General Counsel John E. Osborn while he held a visiting academic appointment at the Centre for Socio-Legal Studies at Oxford.  The article, Can I Tell You the Truth? A Comparative Perspective on Regulating Off-Label Scientific and Medical Information will appear in the Yale Journal of Health Policy, Law, and Ethics.  Our friends at the Drug and Device Law Blog provided a link to the study in a post yesterday.

Osborn writes that the federal off-label speech policy “may be . . . the single greatest threat to the pharmaceutical industry” in the U.S.  His article makes a compelling case that despite WLF’s courtroom victories against FDA and the agency’s supposed concessions that some off-label communication is permissible, the federal government uniformly believes that off-label “promotion” is inherently misleading and the government will continue to twist law and logic to silence such speech.  Osborn refers to WLF’s 2004 request that DOJ provide clearer guidance on the investigation of off-label communications cases, and notes how DOJ’s response was indicative of the government’s determination to keep its approach to off-label matters as unclear and unpredictable as possible.

Osborn compares the punitive and counterproductive U.S. approach to how off-label speech is policed in Great Britain, which is mostly through a government-private partnership of self-regulation with clearer government standards as to what is and is not permitted.  Osborn acknowledges that the U.S. lacks Britain’s tradition of self-regulation, but urges U.S. officials to emulate Britain’s “efficiency and transparency.”  He adds:

[O]ur current system, which is based on the precept that a paternalistic FDA is uniquely situated to shield consumers and doctors from the vulgar commercial motivations of industry, is grossly unbalanced.

Federal policy-makers would do well to read John Osborn’s article and give serious consideration to his arguments and policy prescriptions.  We can spend billions on improving access to health care, but if doctors can’t have access to the best and newest information on treatments, those billions could go to waste.