OPDP Cites Lack of Risk Information in Second Warning Letter of 2018

Nov. 2, 2018 – Providing information about a drug product’s benefits without including any risks is an issue that the FDA’s Office of Prescription Drug Promotion (OPDP) does not take lightly, as evidenced by an Oct. 22 Warning Letter from OPDP to Vanda Pharmaceuticals Inc. This Warning Letter is the second Warning Letter issued in 2018; the first Warning Letter was issued Oct. 5 to Mannkind Corp. for allegedly making false or misleading claims and/or representations about its product’s risks.

“OPDP Director Thomas Abrams cautioned, at last month’s Food and Drug Law Institute Advertising and Promotion Conference, that industry should not focus solely on the number of Warning Letters, as these are only one aspect of the overall program of enforcement. But he also noted that in determining when to send Warning Letters, OPDP will give priority to those situations they consider to have the greatest potential negative impact on public health,” said Jon Bigelow, executive director of the Coalition for Healthcare Communication.

In the enforcement letter to Vanda, OPDP states that the company’s “Products” webpage for FANAPT® (ilerperidone) tablets for oral use and HETLIOZ® (tasimelteon) capsules for oral use is false or misleading, “in that it presents information about the benefits of Fanapt and Hetlioz, but fails to include any risk information about either drug.”

According to OPDP, this violation is a public health concern “because it creates a misleading impression about the safety of Fanapt and Hetlioz,” particularly for Fanapt, which is a drug that bears a Boxed Warning due to serious, life-threatening risks. Promotional materials for other products with Boxed Warnings were cited in the Mannkind Warning Letter and in an Oct. 11 Untitled Letter sent by OPDP to Eisai Inc.

Although Vanda’s webpage includes the statements “For U.S. full prescribing information, including box warnings and safety information, please visit,” and “Full Hetlioz prescribing information can be found at,” these statements do not “mitigate the omission of risk information from the webpage. By omitting the risks associated with Fanapt and Hetlioz, the webpage fails to provide material information about the consequences that may result from the use of the drugs and creates a misleading impression about the drugs’ safety.”

In addition to the Warning Letters for Vanda and Mannkind, OPDP has issued five Untitled Letters in 2018. This represents an increase from a total of five enforcement actions (two Warning Letters and three Untitled Letters) issued in 2017.