OPDP Issues First Warning Letters of 2020

J.W. Schomisch
March 9, 2020 at 11:37 AM EST
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The FDA’s Office of Prescription Drug Promotion (OPDP) issued Warning Letters to two companies for the same product-sponsored link on Google. The agency noted it had received complaints about the link through the FDA Bad Ad Program.

OPDP sent Feb. 21 Warning Letters to Outlook Pharmaceuticals Inc. and Mikart LLC, which are co-located in Cincinnati, over a Google-sponsored link for ProCentra (dextroamphetamine sulfate) oral solution, CII (ProCentra), because of a failure to include any risk information about the drug.

“These violations are especially concerning from a public health perspective because they create a misleading impression about the safety of ProCentra, a drug that is a schedule II controlled substance used in the vulnerable pediatric patient population, and bears a Boxed Warning that describes the high potential for abuse, that administration of amphetamines for prolonged periods of time may lead to drug dependence, and states that misuse may cause sudden death and serious cardiovascular adverse events,” the letters said.

The letters noted the sponsored link included claims and/or representations about the use and/or benefits of ProCentra such as, “Explore Your ADHD Medication Options For Your Child.” “However, it fails to communicate any risk information. By omitting the risks associated with ProCentra, the sponsored link fails to provide material information about the consequences that may result from the use of ProCentra and creates a misleading impression about the drug’s safety,” the letters said.

“This misleading presentation is particularly alarming from a public health perspective given that the sponsored link utilizes claims, such as ‘Liquid Treatment Option’ and ‘Bubblegum Flavor,’ that could appeal to parents as desirable properties for pediatric administration, but fails to communicate that ProCentra is a schedule II controlled substance associated with serious and potentially life-threatening risks, such as those contained in ProCentra’s Boxed Warning that describes the high potential for abuse of the drug and states that misuse may cause sudden death and serious cardiovascular adverse events,” the Warning Letters said.

Established Name Also Not Presented

OPDP also noted the sponsored link failed to present the required established name. “The established name of a prescription drug must be presented prominently, in direct conjunction with the proprietary name. The sponsored link fails to present the established name for ProCentra (dextroamphetamine sulfate), thereby misbranding the product,” the letters said.

OPDP requested the companies “immediately cease misbranding ProCentra and/or cease introducing the misbranded drug into interstate commerce.”

The agency requested the companies submit written responses stating whether they intended to comply with the request and to list all promotional materials (with the Form 2253 submission date) for ProCentra that contained similar statements. OPDP also requested plans for discontinuing use of such materials or, in the alternative, for ceasing distribution of ProCentra. “Because the violations are serious, we request, further, that your 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(s) that received the violative promotional materials,” the letters said.

In addition, “in order to clearly identify the violative promotional piece(s) and/or activity and focus on the corrective message(s), OPDP recommends that corrective piece(s) include a description of the violative promotional piece(s) and/or activity, include a summary of the violative message(s), provide information to correct each of the violative message(s), 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 letters said.

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