Off-Label Enforcement, Not Promotion, May See First Changes After Free Speech 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.
You may also be interested in...
FDA advises companies to respond to unsolicited requests for off-label information in one-on-one dialogue; the agency also requests public comments on its policies regarding off-label communications in response to an industry citizen petition.
The Supreme Court's ruling that Vermont's prescriber data mining law violates the First Amendment could help a pharma sales representative to overturn his conviction for promoting a drug for off-label uses.
Citizen petition from seven firms asks agency to issue regulations related to four areas of off-label communications.