FDA Proposes Looser Marketing Rule

The US Food and Drug Administration is a weird chimera: it contains
some elements of rule-bound regulatory hell, and some elements of
laissez-faire libertarianism.  On the libertarian side, they allow
physicians to prescribe any drug that they have approved, even if was
not approved for the use for which it is being prescribed.  On the
rule-bound side, they have incredibly complex rules for how the drugs
can be marketed.  

One such rule is that drug companies are not allowed to market a drug
for any purpose for which the drug has not been approved explicitly.
 That particular rule has been broken a lot, and there have been a
few rather large fines imposed by the FDA because of it.  

Now, the FDA is thinking about changing that.  

Seeks to Broaden Range of Use for Drugs


Published: February 16, 2008

WASHINGTON -- When federal drug regulators approve a
medicine for sale, they limit how drug makers sell it. A drug approved
to treat only breast cancer cannot be marketed for lung cancer even if
some studies suggest that the medicine may save lung patients.

But the Food and Drug Administration proposed guidelines Friday that
would change this, and advocates on both sides of the issue say that
lives are at stake.

The rules would allow drug and device makers to provide doctors with
copies of medical journal articles that discuss product uses that have
not been vetted or approved by the F.D.A. The rules also say that drug
companies do not have to promise to adequately test the unapproved use
discussed in the article...

The basic problem is this: if you don't let the drug companies hand out
information on unapproved (off-label) uses, then doctors might not have
information that could save lives; but if you let companies hand out
whatever they want, then doctors might prescribe medications in ways
that could be dangerous.

Describing it on a higher level of abstraction, the problem can be
stated: if you stop people from performing a class of actions, then you
might stop them from doing something good; if you let people perform
those actions, they might do something bad.  Of course, those
statements usually are true.  There are risks either way.

One might ask, "what's the harm?" in letting drug companies hand out
research papers?  Most of them end up in the trash, anyway, barely
looked at.  I suppose that might be OK if they only handed out
articles printed on recyclable paper, provided recycling bins, and
emptied them at every visit.

But no, even if the doctor only glances at the title, that is enough to
influence prescribing decisions.  In fact, looking at the title
and not reading the whole paper is part of the problem.  The other
part of the problem is that there are very few papers that can be
interpreted properly in isolation.  In order to evaluate the paper
critically, it is necessary to know all the other research that has
been done on the topic.  If there isn't anything else, it is
necessary to know that, too.  

According to the article, some patient advocacy groups are in favor of
the looser marketing restrictions.  This is based on the notion
that greater publicity for off-label prescribing could help people with
whatever disease the group is organized to fight. 

Personally, I think the "saving lives" argument is not valid. 
Physicians who are treating life-threatening conditions really ought to
know what they are doing anyway; they should not need salesmen to tell
them something they don't know.  Physicians who are not experts
with a particular drug or condition should not be using a drug
off-label to treat a that condition. 

If advocacy groups want greater publicity for a given off-label use,
they are free to generate the publicity themselves. 

Yes, some advocacy groups are linked (allegedly) to drug makers. 
Don't know what to do about that.


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I'm not sure that one or two papers should suffice to allow promotion for off-label use, but certainly once a certain number of papers are published (not sure what number would work best) then maybe the FDA could allow an "experimental indication" status that could even be included in a "provisional" package insert (including any dosage information, warnings and precautions specific to that use).

I remember that shortly after Valium (diazepam) injectable was approved as a muscle relaxant someone discovered its rather amazing efficacy in treating status epilepticus. A couple case histories were published, and within a year Valium injectable was recommended as the drug of choice for status epilepticus, even though Roche still didn't have enough case data to file a supplemental NDA with the FDA.

Basically, it boils down to trying to make sure that physicians have the necessary information to prescribe the drug safely for any off label indication.