FDA to Review Off-Label Marketing Regs

Sep 07, 2016

The FDA is announcing a 2-day public hearing to obtain input on issues related to the extent to which off-label information about treaments can be communicated to health care officials by drug manufacturers.

According to the agency, it is engaged in a comprehensive review of its regulations governing manufacturer's communications about unapproved uses of approved/cleared medical products, and the input from this meeting will inform FDA's policy development in this area.

While the FDA has traditionally taken tough stance on off-label marketing, drugmakers have argued that conveying certain types of information is protected by the First Amendment.

The hearing is scheduled for Nov. 9 and 10 at FDA offices in Silver Spring, Maryland.

Read the hearing notification