Labeling Your Health

What if the condition for which the medicine was prescribed is not one of those listed on the FDA-approved label?

Mit SpearsJuly 26, 2012

A physician, equipped with the latest medical and scientific information, prescribes a medicine as the best course of treatment for a patient. The patient follows the doctor's orders, takes the medicine as prescribed and has a positive health outcome.

A remarkable event?

Hardly. This is what doctors do.

But what if the condition for which the medicine was prescribed is not one of those listed on the FDA-approved label? Is that remarkable?

Not at all.

However, an article in today's National Journal suggests otherwise. The article recounts recent penalties against biopharmaceutical companies for allegedly "promoting" off-label usage of medicines, suggests that pharmaceutical manufacturers "prefer sales to compliance" and concludes that stiffer penalties are needed to curb "abusive corporate behavior." Unfortunately, this narrow and one-sided account ignores medical and scientific fact and prefers to rely upon broad mischaracterizations of company motives offered by industry critics.

Prescribing medicines for uses beyond the FDA-approved label is a well-established and accepted part of health care delivery in this country. The FDA itself recognizes that "[o]nce a drug or medical device has been approved or cleared by FDA, generally, healthcare professionals may lawfully use or prescribe that product for uses ... not included in the product's approved labeling." The American Medical Association noted that "the prevalence and clinical importance of prescribing drugs for unlabeled uses are substantial." In 2001, approximately 150 million prescriptions - 21 percent of all prescriptions that year - were written to address conditions beyond those listed on the FDA-approved label. In some medical specialties, such as oncology, the majority of prescriptions are written for unlisted conditions. In many instances, these unlisted uses become the standard of care and both government (Medicaid/Medicare) and private insurers pay for these unlisted uses.

The benefits to patients are manifest. Relying upon available scientific and clinical information, much of which may only have been developed after innovative medicines enter the market, physicians have used medicines in new and innovative ways to combat disease. The fact that HIV/AIDS is now viewed as a treatable disease state is attributable in part to talented physicians using antiretroviral and other drugs in ways unanticipated in FDA-approved labeling.

Physicians need up-to-date information about medicines in order to inform their treatment decisions. What the National Journal piece terms as companies "pushing doctors" is often nothing more than the provision of accurate and truthful information about their medicines, such as clinical research results and articles from medical journals, to help inform physicians about the benefits and potential risks associated with the use of their products.

Instead of creating false dichotomies between "on-label" and "off-label" use, government, healthcare providers and industry should be focused on finding the best ways to ensure that physicians are provided with truthful and non-misleading information about medicines on a timely and effective basis.

For its part, the biopharmaceutical sector has adopted voluntary codes of conduct to ensure companies' communications with patients and healthcare providers are accurate, professional and appropriately focused on patient health and well-being. Individual companies have followed up by adopting and implementing comprehensive compliance plans to accomplish this same objective.

Providing physicians with timely, accurate and non-misleading information about medicines is critical to improving patient care and controlling healthcare costs. Our industry looks forward to working with the FDA and others to improve that process. But in order to do so, we all need to focus on facts, and leave one-dimensional assessments of motives behind.

A note from The Catalyst Editors: This is the inaugural post from Mit Spears, Executive Vice President and General Counsel for PhRMA. Mit leads PhRMA's law department and is an expert on antitrust and trade regulation, consumer law and life sciences issues.


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