Can’t Hardly Wait: OPDP Issues a Notice of Violation Where Risk Information Was Not Provided Adequately

In 1987, the influential garage rock band, The Replacements, led by Paul Westerberg, sang, “I can’t hardly wait.” Years later, the Food and Drug Administration issued a Notice of Violation — the second this year — to a pharmaceutical company for unlawful promotion, when it found that the company’s celebrity spokesperson posted on her personal Instagram account about the company’s prescription drug product but did not include any safety information.¹ While there was a link to click for more safety information, the agency concluded it was insufficient.

This Bulletin will highlight FDA’s concerns and offer our own recommendations.

Highlights

• The company engaged a celebrity spokesperson who posted on her personal Instagram account about the benefits of the product indicated for, among other uses, emergency treatment of allergic reactions.
• FDA highlighted that the product’s approved patient population includes infants and children “with life-threatening allergic reactions who are at increased risk of adverse outcomes, including death.”
• The post noted “[p]aid partnership with [the product name].”
• FDA found that the post provided the product’s benefits without any risk information.
• FDA acknowledged that the post noted where important safety information could be found, tagging the product’s Instagram page. However, the agency said this was inadequate, and the omission of risk information made the presentation of risk information misleading (i.e., misbranded).

AGG Observations

As we constantly advise clients and have included in previous Bulletins:

• If a company provides the good (i.e., indication and benefits), it must provide some of the bad (i.e., safety information in the same venue or setting).
• A company is responsible for the messaging of its agents where it can control the content. In this case, the company engaged the spokesperson and, even though the messaging was in a personal social media account, the firm could control the content.
• A company does not have to provide all of the safety information in one place, but it must provide some fair balance at the same time. One can offer a link to review additional safety information, but it cannot present all of the good in the first place and require the user or reader to visit a second place for the bad.
• Marketing to parents of children with potentially life-threatening conditions increases regulatory scrutiny.
• While we think it is highly unlikely that Mr. Westerberg was referring to FDA’s fair balance requirement and important safety information when he sang that he could not hardly wait, the agency certainly made it clear that a company can’t make the user or viewer of a social post wait to see such risk information.

[1] The Untitled Letter is available here: www.fda.gov/media/180350/download.