FDA Goes Off-Label

by Jack Lewin January 22, 2009 04:15

The Food and Drug Administration (FDA) has finalized guidelines for pharmaceutical companies to be further able promote off label uses for drugs to physicians, and particularly through peer-reviewed medical journals. The new guidelines are provoking criticism from some sectors that the FDA is allowing companies to promote products to doctors even if the uses have not been rigorously vetted.

It general this seems a practical thing for FDA to do to me, given the numbers of off-label uses in practice, but with discretion when adverse risks are not well known or documented. Maybe this could allow for more responsible educational venues around off-label uses, given that the funding to research these uses is in short supply now, and will likely be until Bank of America, Citibank, and average taxpayers like you and me are back on our collective feet. This will be an early challenge for the next FDA Commissioner -- haven’t heard anymore about where that decision is this week, except that there are three prominent cardiologists alleged to be close contenders now.

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About the author

Jack Lewin has been chief executive office of the American College of Cardiology since November 2006. Under his leadership the College has continued to build upon its standing as a national leader in advocacy, with a particular focus on reforming Medicare, Medicaid, and the financing and delivery of quality health care. Learn more about Dr. Lewin.

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