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Category Archives: Legal
Off-Label Comments Online: Keep Doing What You're Doing, Says FDA
Those in favor of a less is more approach to FDA social media guidelines got what they wanted for the holidays: a trim, 15-page document on how to respond to unsolicited off-label comments
Also posted in Advertising, E-Media, FDA, Marketing, Regulatory, Technology, compliance, social media Tagged FDA Leave a comment
Why the Delay on Facts Boxes?
Despite a near-complete absence of criticism coming from industry, academia, clinicians and patients, the drug facts box – a concise, quantitative, easy-to-read format for presenting a drug’s risk/benefit profile in print advertisements – seems at least three years away from launch.
Also posted in Advertising, FDA, Marketing, Regulatory, Strategy, patient education Tagged facts box 1 Comment
Supreme Court Strikes down Vermont Law, Upholds Rep Free Speech
June 23rd was a good day for the pharmaceutical industry. The Supreme Court released two decisions that largely went pharma’s way. There was much rejoicing across the industry, and for good reason, business as usual won out.
In PLIVA v. Mensing, the Court ruled that generic drug companies should comply with federal regulations instead of [...]
Supreme Court Ruling Makes Generics More Dangerous
Today’s Supreme Court ruling on Pliva v. Mensing, which held that generic drug companies are not responsible for updating drug labels in light of new safety concerns, makes taking generic drugs a riskier proposition for consumers, Justice Sonia Sotomayor wrote in her dissenting opinion. Justices Stephen Breyer, Elena Kagan and Ruth Bader Ginsburg also dissented [...]
Genentech Runs Voluntary Corrective Ads for Boniva