Topic 34: New FDA Consumer Advertisement Guidance and Potential MA Impact

Have you seen the new FDA guidance about disclosing risk in consumer-directed print advertising that came out in February? (You can see it here) Unless you are a gluten for FDA guidance-reading punishment, my guess is that you skipped this one since it seems to be commercially focused.

BUT, there is actually something that MA should be aware of and perhaps an opportunity to add some value to our commercial brethren. The focus of the guidance is straight forward – under current law print advertising has to also disclose risks, and the safest approach for disclosing that risk is to publish the full package insert (PI) along with the print ad. As we know PIs are a tough read normally, but when shrunk down to fit in a magazine they are almost unreadable and certainly mostly incomprehensible to the very audience they are supposed to be protecting – consumers.

This has not been lost on the FDA and the guidance linked to above was entirely focused on resolving this issue.

In an FDA survey, few respondents reported reading half or more of the brief summary presented in the traditional format. Of those who read at least some of the brief summary, 55 percent described it as hard to read. Over 40 percent of respondents in the survey reported they do not usually read any of the brief summary in direct-to-consumer prescription drug print advertisements.

The FDA realizes that the full PI is aimed at medical professionals and full of details that the vast majority of consumers don’t care about like clinical pharmacology or chemistry. So the FDA is suggesting that manufactures should have the flexibility to replace the PI with something they are now calling “consumer brief summary.”
What is a consumer brief summary? Per the guidance it is an explanation written in consumer-friendly language (ie. drowsiness not somnolence) that includes:

• Boxed warnings
• All contraindications
• Certain information regarding Warnings and Precautions:
  • The most clinically significant information from the Warnings and Precautions section(s) of the PI;
  • Information that would affect a decision to prescribe or take a drug;
  • Monitoring or laboratory tests that may be needed;
  • Special precautions not set forth in other parts of the PI;
  • Measures that can be taken to prevent or mitigate harm
• Most frequently occurring Adverse Reaction, and those ARs that are serious or that lead to discontinuation of use, and the severity of the risk
• Indications for use
• Significant drug interactions

And this is where Medical Affairs comes into play. Now our commercial colleagues and their agencies are going to be needing to develop information that includes medical judgement, like:

• What is the most clinical significant information?
• Why is that information considered most clinically significant?
• How do practitioners view what is most clinically significant?
• What information should affect the decision to take or prescribe the drug?

These questions are great ones for Medical Affairs to either provide guidance, answer directly or gather information from practitioners during their interactions to answer these questions and others. Given the proper but strong firewalls between MA and commercial, this new guidance provides a value-added opportunity for MA to provide some guidance to commercial.

MA leaders may wish to discuss this topic with their commercial colleagues.

Do you have any thoughts on the new guidance? Leave them in the comments by clicking HERE and scrolling down to the comment box.