Drugmakers Ask FDA to Clarify DTC Ad Summary Content Requirements

Drugmakers are urging the FDA to clarify how and why the consumer brief summary in direct-to-consumer print advertisements should differ from FDA-approved patient labeling and medication guides.

In its February draft guidance on disclosing risk information in DTC ads, the FDA says the summary should limit adverse events to those most common for each indication. Further, it may need to include information not contained in patient labeling.

In one of 148 comments to the agency, Merck says that would undermine the gains achieved through step-by-step regulatory approval of product labeling and could confuse patients as to which information they should rely on — the labeling or the CBS.

Allergan asks the FDA to provide an example to help drugmakers visualize what the complete format should look like if done properly and what risk information is considered most important. Sanofi also requests that the final guidance be more definitive about the specific prescribing information that should be included in print ads.

Allergan says that, in cases where a product has multiple package inserts, one consumer brief summary should suffice if the risk information within each PI is similar. This would also reduce consumer confusion that could arise from seeing different summaries, the company says.

PhRMA takes issue with the FDA’s plan to use discretion in enforcing labeling regulations to permit labeling that complies with the guidance, saying the regulations should be amended to reflect the new policy.

The guidance should also make clear that failure to include the entire package insert in the ad summary doesn’t mean the consumer ad fails to meet the labeling requirements, PhRMA adds.

Sanofi suggests that companies be allowed to include the most serious product risks in the body of the ad and display the remaining important risk information in the accompanying brief summary. This could help consumers view the overall ad more holistically, the company says.

View the draft guidance, Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs, at www.fdanews.com/02-06-15-riskinfoguidance.pdf. — Kellen Owings