Topic: Off-label drugs

JD Supra Corporate Brief: California Fracking, COPPA Rules, Off-label Marketing, FRAND Royalties

Today’s forecast: partly cloudy with a chance of law news: Will California lawmakers succeed in keeping fracking out of the state? (LXBN) Could President Obama’s proposed new cap on tax-favored retirement benefits do a lot more harm than good? (Osler) According to FINRA, employee social media privacy laws may conflict with securities regulations and threaten… Read more »

Off-Label Marketing Opinion Sends Warning to Pharmaceutical Companies

“The Ninth Circuit has reopened a door for off-label marketing prosecutions, and it is important to review your compliance and risk management programs in light of this recent decision.” (Sheppard Mullin) Earlier this month, the Ninth Circuit issued an opinion that sends an important warning to pharmaceutical manufacturers: the First Amendment doesn’t protect off-label marketing… Read more »

Off-Label Marketing Conviction Violates First Amendment

“In an opinion that will certainly be welcomed by many in the industry, the court rejected the government’s interpretation of the Food, Drug and Cosmetic Act’s (FDCA) misbranding provisions, holding, ‘We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful off-label use of an… Read more »

FDA Proposes Social Media Guidance on Off-Label Drug Use

It’s estimated that one in five prescriptions treat ailments other than those for which the drug was originally intended. Off-label use of pharmaceuticals and medical devices, as this practice is called, is big business. But for manufacturers seeking to inform the public about the benefits and dangers of using medications off-label, it’s also risky business: while… Read more »