OPDP Issues Warning Letter Over Radio Ad

J.W. Schomisch
September 16, 2020 at 04:25 PM EST
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The FDA’s Office of Prescription Drug Promotion (OPDP) issued an Aug. 31 Warning Letter to Sprout Pharmaceuticals in Raleigh, North Carolina, concerning a direct-to-consumer (DTC) radio advertisement for Addyi (flibanserin) tablets for oral use.

This is the second Warning Letter and third enforcement letter OPDP has issued in 2020.

OPDP alleged that the Sprout ad made false or misleading claims about the risks associated with Addyi, which is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder. “These violations are concerning from a public health perspective because they create a misleading impression about the safety and effectiveness of Addyi, a drug that bears a Boxed Warning due to the risk of severe hypotension and syncope in certain settings,” the Warning Letter said.

OPDP noted advisory comments the agency made in August 2016 to Valeant Pharmaceuticals International, which at the time was the parent company of Sprout Pharmaceuticals, expressed similar concerns. “We are concerned that, in the radio ad, Sprout is continuing promotion of Addyi in a manner that does not adequately convey the FDA-approved indication nor the important risk information for the drug,” OPDP said.

The Warning Letter said the ad included numerous claims and presentations regarding the benefits of using Addyi, but “it completely omits all the contraindications associated with the use of Addyi.” In addition, while the ad presented some risk information from the Boxed Warning such as: “. . . low blood pressure and fainting in certain settings . . . ” it omitted material information pertaining to these risks.

“Specifically, the radio ad fails to disclose material information from the Boxed Warning that the use of Addyi and alcohol together close in time increases the risk of severe hypotension and syncope,” the Warning Letter said.

The radio ad also failed to disclose material information from the Boxed Warning that the use of Addyi with certain prescription medications or in patients with liver problems increases the risk of severe hypotension and syncope, OPDP said. “The radio ad also omits the warning and precaution regarding central nervous system depression, and it fails to include material information that the use of Addyi − without other concomitant medications known to cause hypotension or syncope – can cause hypotension and syncope.”

“By omitting risks associated with Addyi, the radio ad fails to provide material information about the consequences that may result from the use of the drug and create a misleading impression about the drug’s safety,” the Warning Letter said.

OPDP noted the ad included the following claims:

  • “1 in 10 premenopausal women suffer from frustrating low libido, also known as HSDD.”
  • “Meet Addyi – the first and only FDA-approved non-hormonal pill for acquired, generalized HSDD in premenopausal women. In other words: An FDA-approved pill for women frustrated by their low libido.”
  • “Ladies, add your desire back with Addyi.”

“These claims create a misleading impression regarding the scope of the approved use of Addyi by omitting material information about the product’s approved indication and the limitations of its use. Specifically, the “What is Addyi?” section of the Medication Guide states: “Addyi 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; or medicine or other drug use. . . . Addyi is not for use to improve sexual performance.”

“By failing to adequately communicate the indication and limitations of use associated with Addyi, the radio ad creates a misleading impression about the FDA-approved indication. This is particularly concerning given the serious risks of this product and the suggestion that Addyi is approved for all women ‘frustrated by their low libido’ when this is not the case,” the Warning Letter said.

Corrective Advertising Requested

OPDP requested the company “immediately cease misbranding Addyi and/or cease introducing the misbranded drug into interstate commerce.” The agency also requested a written response to the Warning Letter stating whether the company intended to comply with the request and listing all promotional materials (with the 2253 submission dates) for Addyi that contain similar statements.

The FDA also requested a “plan for discontinuing use of such materials, or, in the alternative, for ceasing distribution of Addyi.” In addition, because the violations were deemed serious by the agency, OPDP also requested the submission include “a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience that received the violative promotional material. In order to clearly identify the violative promotional piece and/or activity and focus on the corrective messages, OPDP recommends that corrective piece include a description of the violative promotional piece and/or activity, include a summary of the violative messages, provide information to correct each of the violative message, and be free of promotional claims and presentations. To the extent possible, corrective messaging should be distributed using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated.”

The agency noted that if the company believed the product was not in violation of the Food, Drug and Cosmetic Act, it should include the reasoning and any supporting information in the response.

Editor’s note: All FDA Warning and Untitled Letters are available in Thompson Information Services’ FDA Enforcement Letter Database, which is available to subscribers of Thompson's FDA Compliance Expert.

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