Off-Label Use - Clarification of FDA Policy

Mark Meer

Trusted Information Resource
#1
I've been trying to get a handle as to what the FDA policies are with respect to off-label use of medical devices (and drugs too, assuming the policies are similar).
From the reading I've done thus far, it appears that the following views are held by the FDA:
  1. Off-label use is acceptable in certain circumstances, and is generally the responsibility of the issuing health-practitioner.
  2. Manufacturers may not publicly advertise, promote, or make claims of off-label use.
  3. Manufacturers may, however, provide off-label use information in response to unsolicited requests, provided that the information is delivered non-publicly in a one-to-one communication, and deals only with the specific request.
Can anyone kindly confirm that this is an accurate summary of current FDA policy?

I'd like to open this thread as a general discussion of off-label policies and scenarios. Forgive me if such a thread already exists (Elsmar.com search for "off-label" truncates the "off" due to insufficient characters). If so, kindly link to the existing thread, and we'll continue to discuss over there... ;)
 
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Watchcat

Trusted Information Resource
#2
I'm not sure but what FDA is still trying to get a handle on its policies with respect to off-label use, too.;) I don't find it encouraging that the website's guidance for PIs and IRBs has not been updated since 1998:
Off-Label Use of Marketed Drug or Device

I don't take this as an indicator that they think they got it solid in 1998. I think it is more likely that they have yet to sort things out solidly enough to warrant updating the 1998 guidance. There is certain cover to be found in really old guidance, while more recent guidance, you have to be prepared to stand by it.

I think the fact that their guidance for FDA staff and industry is still in draft form is probably more on point.
Responding to Unsolicited Requests for Off-Label Information About Pre

I concur with #2 and #3.

#1 is one of those areas where I have a strong opinion about what FDA's policy SHOULD be, but, with old and draft guidances abounding, am never quite sure what it is. I don't think FDA has, or should have, any say over whether off-label use is acceptable, because I don't the FDA has the authority to regulate product use, only the use intended by the manufacturer. Thus, off-label use should not be "generally the responsibility of the issuing healthcare provider," but should be entirely at the discretion of the issuing healthcare provider...and the patient, where products are available OTC.

If you focus on the use intended by the manufacturer, then I don't think "off-label" is ever acceptable.
 
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