Back in the BR
Member since Oct 2003
Off-label promoting of drugs ruled Free Speech by 2nd circuit (Posted on 12/10/12 at 4:59 pm)
NY Times article
In a case that could have broad ramifications for the pharmaceutical industry, a federal appeals court on Monday threw out the conviction of a sales representative who sold a drug for uses not approved by the Food and Drug Administration.
Under the Food, Drug and Cosmetic Act, which gives the F.D.A. the authority to regulate drugs, selling a “misbranded drug,” or one that is intended to be used for purposes not listed in the label, is illegal. Doctors, on the other hand, are free to prescribe a drug for any use.
Good? Bad? What's your take?
IMHO, this is a good thing as it does not allow "snake-oil" sales pitches, but does allow dissemination of more current study data without requiring the manufacturer to spend additional tens of millions of dollars to have the FDA approve new indications.
Case in point: when Nasacort AQ, a steroidal nasal spray for allergies first hit the market it was indicated for the symptomatic relief of seasonal allergies only. Aventis, the manufacturer, did not want to spend the additional money to also get the perennial allergy indication. This saved Aventis over $10 million in study and filing expenses.
The more a drug company has to spend to get a drug to market, the higher the selling price for the drug.