Latest Untitled Letter from FDA’s OPDP Underscores Need for Careful Approach to Advertising

Late last month, the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued its fourth Untitled Letter of the year to AbbVie, Inc. FDA uses Untitled Letters to inform of “violations that may not meet the threshold of regulatory significance for a warning letter and request correction of the violations.”

The Untitled Letter addresses a television advertisement for Ubrelvy that features Serena Williams. Among other issues cited in the Untitled Letter, the OPDP asserts that:

• “[T]he TV ad makes false or misleading representations and suggestions about the efficacy of Ubrelvy[ and thus] misbrands Ubrelvy within the meaning of the Federal Food, Drug and Cosmetic Act.”
• “The[] claims . . . misleadingly suggest that Ubrelvy provides greater benefits to patients with acute migraine headache than has been demonstrated.”
• “[T]he use of a celebrity athlete in this TV ad amplifies the misleading representations and suggestions made and increases the potential for audiences to find the misleading promotional communication more believable . . . .”

Managing the Risks of High-Profile Advertising

While companies need to take a compliance-focused approach to all of their advertising efforts, high-profile advertisements require especially close scrutiny. This is particularly true for advertisements targeting consumers. When placing ads on TV, it is essential to ensure that these ads are compliant in all respects—including, but not limited to, accurately reflecting a product's effectiveness or capabilities.

As noted in the OPDP’s Untitled Letter to AbbVie, Inc., advertisements that include celebrity endorsements raise particular concerns from an enforcement perspective, as “the perceived credibility of the source” means that more consumers are likely to take the contents of these advertisements at face value. This is true not only on TV, but also on social media and other online (and print) platforms.

With this in mind, here are some tips for effectively managing advertising compliance:

#1: Develop and Implement Advertising Compliance Policies

All pharmaceutical and medical device companies should have documented advertising compliance policies. These policies should address all pertinent laws and regulations, including (but not limited to) those enforced by FDA.

#2: Provide Training to Relevant Personnel

Relevant personnel should receive training on the company’s advertising compliance policies. This includes (but may not be limited to) members of the company’s sales, marketing, medical affairs, and reimbursement teams, as well as other commercial staff.

#3: Have All Promotional Materials Reviewed By Qualified Medical, Legal and Regulatory Professionals

Prior to publication, pharmaceutical and medical device companies should have all draft promotional materials reviewed by qualified medical, legal, and regulatory staff. This is memorialized in FDA guidance. Experienced legal counsel should be able to identify any potential compliance-related concerns and assist with revising or replacing any offending claims.

Contact the Team at Gardner Law Today

At Gardner Law, we assist drug and medical device companies and other manufacturers with all aspects of FDA compliance. This includes promotional compliance. If you would like to speak with one of our attorneys about your company’s regulatory and compliance policy needs, training needs or proposed advertisements, contact us to schedule a consultation today.