Topic: Drugs

FDA’s Proposed Rule on Generic Drug Labeling Could Sow Confusion and Chaos (and Lawsuits)

The FDA wants to give generic drug makers the same labeling authority as their branded peers. Attorneys Erin Bosman, James Huston, and Julie Park of Morrison & Foerster explain: [T]he U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule … in an effort to ‘create parity’ between brand-name and generic manufacturers for their… 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 »

Supreme Court Rules Generic Drug Makers can Challenge Brand-Name Patents

On April 17, 2012, the Supreme Court ruled in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S that generic drug makers can sue brand-name drug makers when the latter claim exaggerated descriptions of indications covered by their patented drugs. The Food and Drug Administration has historically allowed brand-name drug makers to write their own descriptions… Read more »