Pre-approval Promotion: Corporate Communications May Draw US FDA Scrutiny

26 Mar 2019

Biopharma sponsors should start with information that needs to be disclosed to satisfy SEC rules and understand how a press release will be used to avoid running afoul of agency regulations, industry exec says; company contracts with investigators also should set limits on what they can say about an unapproved drug.

Corporate press releases announcing information that is material to investors, and clinical investigator comments about pipeline drugs, can create pre-approval promotion enforcement risks for biopharma companies, regulatory and legal experts say.

When it comes to corporate communications, companies should begin with information that needs to be disclosed to satisfy Securities and...