Pharmaceutical Company Makes the FDA’s Naughty List

NEWS BRIEF

A warning letter was sent from the US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) for misleading advertising for the drug ProCentra, an oral solution used to treat attention-deficit/hyperactivity disorder.¹ The warning letter was in response to a sponsored link on Google.com that failed to include risk information and use the medication’s established name. The letter also notes that the FDA Bad Ad Program received complaints.

The OPDP explained that the ad suggests the drug’s efficacy and ease use by pointing out its “Bubblegum Flavor” and “Liquid Treatment Option,” all of which easily would appeal to parents as desirable for children, without including any risk information.

The OPDP noted:

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 letter was sent to Stefan Antonsson, CEO of Outlook Pharmaceuticals, with specific corrective actions requested. For starters, the company must “immediately cease misbranding.” In addition, they must respond in a letter detailing not only how they will comply with this request, but, since the violations are deemed serious, they must include “a comprehensive plan of action to disseminate truthful, nonmisleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials.”

According to Regulatory Focus, the ad has been removed and the CEO will respond to the letter.²

Meanwhile, its likely Outlook is not alone in such missteps. According to AdComplyRx, more than 30 major prescription brands inadvertently ran non-compliant ads on Google and Bing.³ Nonetheless, the warning letter, which is the first of its kind for this calendar year, shows that the FDA is watching and will hold companies responsible.

References:

1. Haffer AST. Warning Letter: Re: ANDA 040776 PROCENTRA® (dextroamphetamine sulfate) oral solution, CII MA 60. US Food and Drug Administration. February 21, 2020.

2. AdComplyRx. Homepage: 2018 Brand Safety Report. www.myadcomplyrx.com. Accessed March 5, 2020.

3. Brennan Z. OPDP Warns Pharma Company for Sponsored Link on Google. Regulatory Focus. www.raps.org. March 2, 2020.