A drug marketing rep who got busted for promoting off-label drug uses got his conviction overturned yesterday, and his victory could have a huge impact on Big Pharma, the New York Times reports.
Ex-Orphan Medical sales rep Alfred Caronia successfully argued to a Manhattan appeals court that the First Amendment gives him a right to promote drugs for uses not approved by the FDA.
The ruling could be very good news for major drug companies, which have had to pay out big bucks in off-label marketing cases.
While the ruling only applies in Manhattan, the opinion will likely stop the FDA from pursuing convictions in similar cases until the courts finally resolve the issue, experts told The Times.
It's always been perfectly legal for doctors to prescribe drugs for uses that the FDA hasn't approved. However, federal law has barred drug companies from promoting medicine for anything other than its officially approved use.
Caronia was convicted after being caught promoting narcolepsy drug Xyrem for insomnia, fibromyalagia, and other condictions, according to the Times.
Thomas Liotti, a lawyer for Caronia, told Reuters the decision "increases the marketability of drugs, and means consumers can be fully informed by sales representatives, manufacturers, and their physicians."
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