Off Label on the Table

  • by: |
  • 06/02/2014

There’s a difference between off-label communications and off-label marketing – and it’s more than a finesse. It’s one of those 800-pound gorilla issues we’ve been pussyfooting around for too long. And now, at long last, it’s time for a serious conversation.

Here’s a bit of outreach send out by PhRMA. It’s well said. It’s brief. And it's a call to action. Take it seriously.

FDA Restrictions on Medical Communications Can Negatively Impact Patient Care

Some of the regulations and guidances of the Food and Drug Administration (FDA) have a more direct impact on patient care than others.  The FDA’s restrictions on biopharmaceutical companies’ ability to share authoritative, regulated data about prescription medicines limits healthcare professionals’ access to information that can help them make informed decisions based on their patients’ individual healthcare needs and preferences.

Biopharmaceutical companies have the most complete and up-to-date information about the medicines that they research, develop and manufacture for use by patients.  However, companies are often unable to proactively share valuable information about their medicines, especially for information that is not contained in the FDA-approved prescribing information (the package insert you often receive with a prescription), with physicians and other healthcare providers.

To get the best possible health outcome for patients, FDA should revise its regulations to allow companies to share truthful, scientifically accurate, and data-driven information with healthcare professionals to inform treatment decisions.  Some examples of this kind of information include:

·         Observational data and “real world evidence” – Information on the safety and effectiveness of medicines taken from medical records based on actual use of approved medicines.

·         Sub-population data – Information on the safety and effectiveness of medicines in sub-populations including gender and race.  Such information can help healthcare professionals tailor their treatment to meet the needs of individual patients.

·         Observational and comparative data – Information from the use of a medicine outside of randomized clinical trials, especially comparisons between two or more therapies.

·         Pharmacoeconomic information – Healthcare economic data and information on the economic value of medicines can improve the efficiency of patient care.

·         Information on medically accepted alternative uses of medicines – Information on new uses of approved medicines that are listed in major compendia and/or routinely reimbursed by the federal government and major payers.  As the National Cancer Institute states, “Often, usual care for a specific type or stage of cancer includes the off-label use of one or more drugs.”[1] Healthcare professionals help patients by applying new uses of approved drugs in “every specialty of medicine.”[2]  When patients are being prescribed medicines off-label, they deserve to know that their healthcare professionals have the latest information on these uses.

You Can Help.  Patients need their healthcare professionals to have timely, authoritative, FDA-regulated information about available medical treatments.  Currently, the House Energy and Commerce Committee is soliciting comments from patients, providers and other stakeholders about how they learn about new treatments and cures.[3]  If you believe that physicians and other healthcare professionals should have access to sound, evidence-based information that biopharmaceutical companies have about their medicines in order to help patients make informed healthcare decisions, please send a comment to by June 13, 2014.

[1] See National Cancer Institute, Off-Label Drug Use in Cancer Treatment, available at

[2] Christopher M. Wittich, et; al., Ten Common Questions (and Their Answers) About Off-label Drug Use, Mayo Clinic Proceedings, available at

[3] See


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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