Topic: FDCA

FDA Proposes New Policy to Boost Development of Fixed-Combination Drug Products

“FDA’s new interpretation of these terms would result in a determination of 5-year [New Chemical Entity] exclusivity for each active ingredient in a drug product instead of the drug product as a whole.”  (Carlson Caspers) The Food and Drug Administration has proposed a policy change that should give combination therapies a shot in the arm.… 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 »