For The Defense, November 2012 - DRI Today
For The Defense, November 2012 - DRI Today
For The Defense, November 2012 - DRI Today
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Drug and Medical Device<br />
Fitting a Round Peg<br />
into a Square Hole<br />
By Frederick H. Fern<br />
and Kelly E. Jones<br />
It is time for the FDA<br />
to rethink policy, as the<br />
prohibition on off-label<br />
marketing and the recent<br />
Guidance on responding<br />
to unsolicited requests<br />
for information do little<br />
to advance the agency’s<br />
mission to ensure that<br />
all drugs and devices<br />
are safe and effective.<br />
22 ■ <strong>For</strong> <strong>The</strong> <strong>Defense</strong> ■ <strong>November</strong> <strong>2012</strong><br />
FDA Off-Label<br />
Promotion Rules<br />
in the World of<br />
Social Media<br />
<strong>The</strong> Food and Drug Administration (FDA) released new<br />
draft guidance on December 23, 2011, entitled, “Responding<br />
to Unsolicited Requests for Off- Label Information<br />
about Prescription Drugs and Medical Devices.” <strong>The</strong> guid-<br />
■ Frederick H. Fern, a registered pharmacist, is a member of Harris Beach PLLC in New York City and the<br />
leader of its Medical & Life Sciences Practice Group and a member of the <strong>DRI</strong> Drug and Medical Device<br />
Committee. Kelly E. Jones is a senior associate with Harris Beach PLLC and focuses her practice in New<br />
York and New Jersey on litigation and consulting involving FDA- regulated products. Ms. Jones serves on the<br />
steering committees for the <strong>DRI</strong> Drug and Medical Device and Young Lawyers Committees. A special thank<br />
you to Andre Major, a third-year law student at Brooklyn Law School, for his assistance with this article.