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.