The journal "Nature Medicine" has a disturbing article on a legal decision
concerning whether a Food and Drug Administration (FDA) approved drug
can be used or advertised for "off-label" use. The FDA typically requires
that a drug company demonstrate evidence that a drug is effective in the
treatment of a condition and, if shown to be effective, the drug can then be
marketed for treatment of this disease/disorder. However, physicians
sometimes (often?) will use a drug shown to be effective for one condition
for another condition for which it has not been researched, a practice
called
"off-label" use. Physicians can take any FDA approved drug and use it
in an off-label manner for a condition that they and their patients are
willing
to treat even though there is no research evidence that such use is
effective.
It should not come as a big surprise that off-label drug use is a widespread
practice among physicians. However, according to the FDA such use is not
legal but it usually prosecutes cases where significant marketing is
involved..
The FDA will prosecute individuals and companies that promote off-label
use of its approved drug, especially in advertising, and this is the heart
of
our story. Quoting from the article:
|In a 2-to-1 decision, the judges stated that banning off-label marketing
|violated the representative's freedom of speech. This ruling is a mistake,
|as it upholds the freedom of speech of people with a vested interest in
|promoting a product without considering the risk this represents for
patients.
|By opening the door to off-label drug promotion by people with commercial
|motivations, the court decision undermines the authority of the FDA and the
|process whereby new drugs are approved. Indeed, the dissenting judge,
|Judge Debra Ann Livingston, argued that if pharma companies can promote
|FDA-approved drugs for nonapproved uses, "they would have little incentive
|to seek FDA approval for those uses." In other words, why bother with a
|long and expensive clinical trial if one can just market a drug without it?
|
|The court found that, as long as the information that pharma sales
representatives
|give to doctors is true, the FDCA cannot curtail their freedom of speech.
The
|decision therefore changes the burden of proof for prosecution of companies
|for misbranding a drug in accordance with the FDCA. It will no longer be
|enough to spot off-label marketing to cry foul; instead, it will be
necessary to
|show that the information presented is false.
Here is the critical part:
|But, considering that there are essentially no clinical efficacy data for
using
|Xyrem to treat Caronia's broad list of diseases, the ruling did not seem to
|take into account whether his statements were true or not. For the purpose
|of the decision, they seem to have been considered as true enough.
http://www.nature.com/nm/journal/v19/n1/full/nm.3061.html?WT.ec_id=NM-201301
The original case involved a physician's treatment of several conditions
(e.g., fibromyalgia, chronic pain, Parkinson's disease) with the drug Xyrem
(a drug FDA approved to treat catalepsy and narcolepsy; it is also known
as GHB and has been used as a date-rape drug). The judges essentially
said that banning off-label marketing of a drug was a violation of a
person's
freedom of speech. The issue is whether any claim that the drug is
effective for
conditions that it was not originally FDA tested for, should be considered
a "true" statement because there is no evidence that it is an appropriate
treatment
for the condition. Yet it appears that the judges did not appreciate this
point
and/or considered the truthfulness of the statement as not as important as a
person or drug company's "right" to claim that the drug can be used for
almost
any condition.
Something to think about.
-Mike Palij
New York University
[email protected]
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