Yesterday, I had the opportunity to speak at a conference of regulatory and compliance professionals – those who are dedicated to ensuring that regulation works.
At the conference, I posed two important questions. Have the regulatory processes regarding how biopharmaceutical research companies communicate about their technological advances kept pace with patient needs and with the advances themselves? And, as the ways in which we communicate with each other have been revolutionized in the past decades, is the regulatory paradigm allowing the healthcare community to take advantage of new methods of communication for the betterment of patient care?
My answer to both, I am afraid, is no.
Consider this: 20 years ago, physicians received most of their information from a select group of resources: medical journals, package inserts, and the all-important Physicians’ Desk Reference. Now, there is a flood of information from a wide variety of sources, at the same time that demands on physicians’ time are unprecedentedly high and that the complexity of biopharmaceutical science continues to grow.
As the practice of medicine has evolved, unfortunately the regulations governing biopharmaceutical company communications with the medical community have not. Companies face significant restrictions in terms of how they are able to communicate scientific information about the products they make, including related to medically-accepted alternative uses of approved medicines, often referred to as off-label uses.
These medically-accepted alternative uses are often recognized as the standard of care for patients, and many are even reimbursed. Clearly patients benefit from their healthcare providers being able to learn about these potentially life-saving uses of medicines from the source with the most information on them - the biopharmaceutical companies that researched and developed them.
It is time for us to pivot in terms of how we think about biopharmaceutical company communications with healthcare professionals, including physicians. Let us focus on the message – in this case, truthful, non-misleading scientific information that will help advance patient care – rather than the messenger.
This is an issue that I hope to discuss further here on The Catalyst, and I welcome your thoughts in the comments below.