New FDA Print Disclosures

The FDA has undergone a radical switch in relation to its risk disclosure requirements. What originally started as the FDA expecting The Office of Prescription Drug Promotion (OPDP) to make exhaustive disclosures about risks in print advertisements has now led to the FDA urging a more restrained approach to risk disclosure.

The FDA requires that print advertisements of prescription drugs must contain the statement of the product’s established name, quantitative composition, information in brief summary relating to side effects, contraindications, and effectiveness. In the case of published direct-to-consumer advertisements, the FDA requires and additional statement encouraging consumers to report negative side effects.

Consumer-directed print advertisements for prescription drugs typically must frequently include the complete risk-related sections of the PI. To fulfill the adequate directions for use requirement for promotional labeling pieces, the full PI has generally been used. The FDA has, however, recently decided to change its approach for consumer-directed prescription drug print advertisements and promotional labeling pieces because many consumers are unable to understand it.

To help with this process, the FDA has begun recommending alternative ways of disclosing risk information. This has included eliminating the discussion of minor risks, use of a “Drug Facts” like box of information, a Question and Answer type box, and a Highlights version.

Of course, this information has been set forth in a guidance and is not binding. Nevertheless, it is important that a Sponsor consider appropriate alternatives and stay in line with FDA thinking.

 

See if your proposed promotion meets the new FDA expectations by reaching out to the Firm at Darshan@conformlaw.com or call 215-813-8769.