Beyond the Label

New Regulatory Paradigm Must be Driven by Commitment to Achieving Best Possible Patient Outcomes

12.17.13 | By Mit Spears

Last week, I had the opportunity to participate in a panel discussion at the Elsevier Business Intelligence FDA/CMS Summit entitled, “Beyond the Label.” 

Members of the panel discussed whether we need to revisit how the biopharmaceutical industry communicates with healthcare professionals about the medicines that our companies develop, manufacture and distribute. We addressed whether our evolving communications landscape – for example, social media – calls for changes to the ways in which exchange of healthcare information is regulated.

I believe that it does. But the impetus for a new regulatory paradigm is much bigger than any one medium. Rather, I believe that a new regulatory paradigm must be driven by a commitment to achieving the best possible outcomes for patients.

Right now, biopharmaceutical companies are restricted from discussing basic scientific and medical information with physicians if it exceeds the bounds of the FDA-approved labeling, regardless of whether this information is truthful or whether it relates to an approved use of an approved medicine or a medically-accepted, even widely prescribed, alternative use.

Quite simply, I do not believe that patients benefit when their treating physicians do not have access to information that would help them make important prescribing decisions. In fact, quite the opposite is true: I believe that restricting the flow of factual, data-driven information ultimately lowers quality of care.

For example, the current regulatory regime makes it more difficult for physicians to get information about how approved medicines affect key patient sub-populations differently or how different medicines compare in terms of efficacy and cost.  And it makes it extremely difficult for physicians to obtain timely basic information, such as dosage and potential interactions or side-effects, relating to medically-accepted alternative uses of medicine that may be the standard of care and routinely reimbursed by private and public insurers.

Instead of trying to divine the “promotional intent” behind a communication, the focus of a patient-centric regulatory inquiry should be on whether the communication in question is truthful and provides relevant facts so that prescribers can make appropriate treatment decisions.   

Just as there can be no tolerance for provision of information that is not truthful or is misleading, there should also be no blanket prohibitions against the provision of truthful and non-misleading information.  And any restrictions on communications should reflect an appropriate balance between the value of the information to the prescribing physician and patient and the potential, if any, for harm to the patient. 

Biopharmaceutical companies look forward to engaging in a dialogue with physicians, patients, and payers to make sure that healthcare professionals receive accurate, data-driven information to meet the needs of patients. 

It is time to move beyond the label.

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