Slow Down, You Move Too Fast: OPDP Issues a Warning Letter for Promoting an Investigational New Drug

In 1966, Simon & Garfunkel sang “The 59^th Bridge Song,” which opens with the lyric, “Slow down, you move too fast.” A drug company recently found out the hard way that pre-approval promotion does not leave the Food and Drug Administration “feeling groovy.” The Food and Drug Administration’s Office of Prescription Drug Promotion issued a Warning Letter to the drug company for promoting an investigational new drug.¹  It is not typical for OPDP to send a Warning Letter for pre-approval promotion, but there was a perfect storm of concerns. It has also been some time since OPDP issued a letter for such messaging, reaffirming that it will take action when it believes there is unlawful promotion.

Highlights

• According to 21 C.F.R. § 312.7, a company cannot promote an investigational new drug as safe or effective.
• In this case, the then-CEO and president took part in a video interview, which was hyperlinked on the company’s website.
• The CEO suggested the investigational drug had a clinical benefit to help with COVID-19 treatment, notwithstanding previous FDA public communications to the contrary that the drug did not provide any clinical support for the treatment of COVID-19.
• The video made claims such as, “Our results were really strong,” touted impressive survival rates after giving patients the unapproved drug, and offered other “conclusory statements” about the product’s safety and effectiveness.
• As is typical with a Warning Letter, FDA required the company to provide a plan of corrective action, preferably using the same media and for the same duration of time and with the same frequency that the unlawful messaging occurred.

AGG Observations

• As noted, it is not typical for OPDP to issue a letter for pre-approval promotion, much less a Warning Letter.
• However, there were so many areas of concern (e.g., COVID-19/public health risks, prior communications by FDA, conclusory statements of safety and efficacy) that OPDP believed a Warning Letter and corrective messaging were necessary.
• Companies must pay attention to links to their websites that could contain violative messaging; if the company wants the benefit of the story, it assumes the regulatory risks.
• To make another song reference (this time from the band Foghat), a company with an investigational new drug should “slow down, take it easy,” and not promote the product as safe and effective until it receives FDA marketing approval.

[1] https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cytodyn-inc-626957-02112022.