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Latest From Orphan Medical Inc.
In a partial buy-out by new private equity investor Madison Dearborn Partners, Ikaria is refocused on building out its critical care product portfolio, while a new R&D spin-out may take a route to the public markets. Existing investors have already done nicely through a series of dividends.
The government has decided not to appeal the Second Circuit’s Caronia off-label promotion ruling – no doubt in part because of concerns about the broad reading of the First Amendment currently in favor at the Supreme Court. Officially, FDA has adopted a low-key response. Unofficially, agency officials – notably Bob Temple – are outraged by the ruling. What does Caronia mean for the future of FDA regulation and off-label prosecutions?
In December, the federal appellate court in Manhattan overturned the conviction of a former Orphan Medical sales rep, issuing a broad ruling declaring that truthful, off-label communication is protected by the First Amendment. There was one dissent on the three-judge panel—and FDA officials like Bob Temple hope that the dissent gets more attention than the majority ruling.
In a watershed decision, a federal appeals court declares that manufacturers cannot be prosecuted under the FD&C Act’s misbranding provisions solely for speech promoting off-label use of a drug. Industry attorneys predict the decision, if it stands, will change the government’s approach to pursuing such cases.
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