[e-drug] Re: Intra-dermal use of anti-rabies vaccine? (2)

["James B. Russo" <JBRusso@aol.com>]

Practitioners should be able to look to regulatory agencies for help when  
questions about safe and effective use of marketed drugs arise on a widespread basis. Such a concept is not radical, nor it is new. Half a century ago, when it became clear that lidocaine, approved as a local anesthetic, was being used by cardiologists -- it made the news when Dwight Eisenhower's cardiologists used it to manage his heart rhythms.- FDA asked the  original manufacturer, Winthrop Laboratories, to submit evidence showing lidocaine manages arrhythmias, and at what dosages. The grounds were that clinicians needed solid information, in the package insert, if they were going  to use the drug safely in the new use.  Winthrop did as asked. It was the right thing to do, and besides, cardiologists were accounting for a nice increase in lidocaine sales.  
 
Notably, the change making the lidocaine label reflect the reality of its 
clinical uses was made under a law requiring merely that the drug be safe (the US law requiring proof of efficacy did not pass until 1962). However, FDA's logic -- that a drug for which the label provides no advice on effective use is inherently unsafe -- was compelling. Isn't it still? 
 
James B. Russo
Executive Director
The Partnership for Quality Medical Donations
146 Koenig Rd.
Bernville, PA  19506
USA
jbrusso@pqmd.org
610 488 8303
610 488 7036  (fax)