|Footnotes for this article are available at the end of this page.
On August 31, 2020, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent a Warning Letter to the sponsor of a drug for a violative direct-to-consumer (DTC) radio advertisement.1 The radio advertisement was submitted to FDA under the cover of FDA Form 2253.
According to OPDP, the sponsor’s radio advertisement made false or misleading claims about the risks associated with the prescription drug product and omitted other material facts. Thus, the radio advertisement misbranded the drug within the meaning of the Federal Food, Drug, and Cosmetic Act. The product, which has a Boxed Warning due to a risk of severe hypotension and syncope, continues the agency’s trend to focus on Boxed Warning products and other products that pose significant safety risks to consumers.
We will summarize OPDP’s concerns with the radio advertisement.
- The radio ad did not adequately convey the important risk information for the drug.
- The radio ad included numerous claims regarding the benefits of using the drug, but omitted all the contraindications associated with the drug.
- The radio ad presented some risk information from the Boxed Warning, but it failed to disclose material information from the Boxed Warning that use of the drug and alcohol together close in time increases the risk of severe hypotension and syncope. The radio ad also failed to provide material information from the Boxed Warning that the use of the drug with certain prescription medications or in patients with liver problems increases the risk of severe hypotension and syncope.
- The radio ad omitted other warnings and precautions and failed to include material information that the use of the drug, without other concomitant medications known to cause hypotension or syncope, can cause hypotension and syncope.
- The radio ad created a misleading impression regarding the scope of the FDA-approved indication and the limitations of use, which are part of the indication, for the product.
- The following information included from the Medication Guide for the drug was not included in the radio ad:
- [The product] is a prescription medicine used to treat hypoactive (low) sexual desire disorder (HSDD) in women who have not gone through menopause, who have not had problems with low sexual desire in the past, and who have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner. Women with HSDD have low sexual desire that is troubling to them. Their low sexual desire is not due to:
- a medical or mental health problem
- problems in the relationship
- medicine or other drug use
. . .
[The product] is not for use to improve sexual performance.
- Failure to include the indication and limitations for use associated with the product created a misleading impression about the FDA-approved indication.
- Finally, FDA noted that it had sent previous advisory comments regarding the product and was concerned that the advertisement for the product still did not adequately convey the FDA-approved indication or important risk information for the drug.
- In spite of focusing efforts on the COVID-19 pandemic, FDA continues to enforce what it perceives to be unlawful prescription drug advertising and promotional activities.
- Sponsors are reminded to include material information associated with a product, including the limitations for use of the product, to ensure advertisements and other promotional materials do not create misleading impressions about the FDA-approved indication for the product. We have seen this type of citation noted in other Notice of Violation and Warning Letter communications.
- FDA is particularly focused on Boxed Warning products and high-risk products and ensuring that sponsors adequately disclose such risks in advertisements and promotional materials.
- OPDP’s reference to its previous advisory comments serves as a reminder to follow, or at least consider, these comments or resolve any outstanding issues with OPDP itself. This is particularly important to remember if the company has acquired or licensed the product in a transaction and may not have been the original product owner.
- With a Warning Letter, the company must take corrective action not only for the specific advertisement, but for any and all materials with similar violative messaging.
For questions, please contact Alan G. Minsk.
 The Warning Letter is available at the following: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sprout-pharmaceuticals-inc-610569-08312020.