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Well, you might be interested in the technical guts of that GSK fine. It is related to the idea that no one knows what is legal anymore, and in this case too federal prosecutors drove a man (Peter Gleason) to suicide. Very briefly, once you spend four billion[1] to get a drug approved by FDA for purpose A, a doctor can choose to prescribe it for purposes B, C, and D -- and can publish papers on said applications -- but you as the manufacturer are prohibited from discussing these "off label" applications with other doctors through your salesforce. Even handing out papers is a gray area. So a pharma rep in an office with a doctor concerned about condition B and a patient who suffers from condition B is prohibited, under this FDA theory, from remarking on the utility of his company's drug for condition B. Since ~40% of prescriptions [2] are for off-label uses of drugs, this is a very big deal. The reason for this ban on "off-label marketing" is that the FDA wants you to spend another few billion to take the new application through the entire New Drug Application process; relying on distributed doctors rather than centralized FDA for drug evaluation means FDA loses user fees and review authority. Note that the drug has already been proved safe as dosages in off-label applications are very similar; FDA however does not want doctors to judge on their own whether the drug is efficiacious (these are terms of art in the drug industry). Since FDA cannot regulate doctors directly due to the AMA's clout, they go after drug companies who are under their purview and block them from mentioning anything other than purpose A. With that background, now to the GSK fine:
http://www.justice.gov/usao/ma/news/2012/July/GSKsettlement.... Global health care giant GlaxoSmithKline LLC (GSK) agreed
to plead guilty and to pay $3 billion to resolve its
criminal and civil liability arising from the company’s
unlawful promotion of certain prescription drugs
Under the provisions of the Food, Drug and Cosmetic Act,
a company in its application to the FDA must specify each
intended use of a drug. After the FDA approves the
product as safe and effective for a specified use, a
company’s promotional activities must be limited to the
intended uses that FDA approved. In fact, promotion by
the manufacturer for other uses – known as “off-label
uses” – renders the product “misbranded.”
You might think that sounds a bit like restrictions on freedom of speech. A federal court just agreed: http://online.wsj.com/article/SB1000142412788732371700457815... A federal appeals-court panel on Monday overturned the
conviction of a pharmaceutical salesman for so-called off-
label drug marketing, saying he was protected by free-
speech rights.
The decision could threaten Food and Drug Administration
rules that prohibit the marketing of drugs for off-label
uses, or those that aren't specifically approved by the
FDA.
To make the circle complete, aggressive prosecutions of federal prosecutors for "off-label marketing" resulted in the arrest and subsequent suicide of Dr. Peter Gleason:
http://www.nytimes.com/2006/07/22/business/22drugdoc.html?pa... Indictment of Doctor Tests Drug Marketing Rules
At first, Dr. Peter Gleason thought his arrest was a joke.
In the early afternoon of Monday, March 6, half a dozen
men in suits surrounded Dr. Gleason, a Maryland
psychiatrist, at a train station on Long Island and
handcuffed him.
“I said, ‘Well, this is a gag,’ ” Dr. Gleason recalled in
a recent interview. “They said, ‘No, this isn’t.’ ”
Dr. Gleason, 53, was taken aback because he was arrested,
and later charged, for doing something that has become
common among doctors: promoting a drug for purposes other
than those approved by the federal government.
That was from 2006. Gleason ended up killing himself after his career was destroyed by this prosecution:
http://www.pharmalot.com/2011/07/florida-goes-after-dead-doc... However, the state failed to note one important detail –
Gleason died this past February. The 57-year-old physician
recently saw his medical licenses suspended in
Pennsylvania and California, and the accumulated weight of
the events apparently led him to commit suicide, according
to his sister. We left messages with the Florida
Department of Health about the filing, but not have
received a reply (read the complaint here).
So, to recap here: a federal court has just ruled that the legal theory that Gleason was prosecuted over, and that GSK was fined $3B over, is actually not valid. And a man is dead because of it. Since this is an area I happen to know something about...I'm starting to believe that if domain experts got into the details of these high-profile federal prosecutions (especially for non-violent crimes) they'd find much more abuses like this.[1]: http://www.forbes.com/sites/matthewherper/2012/02/10/the-tru... [2]: http://papers.ssrn.com/sol3/Delivery.cfm/SSRN_ID568402_code3... |