FDA ad police hand Outlook 2020's first warning letter, citing sponsored links

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The first FDA letter of 2020 knocks search marketing advertising for misleading and misbranding the drug name. (FDA)

The FDA's promo police are out with their first warning letter of 2020, and it censures an ADHD drugmaker for misleading search engine marketing.

The Office of Prescription Drug Promotion (OPDP) issued the warning to Outlook Pharmaceutical for “false or misleading” sponsored links on Google for ADHD med ProCentra.

The paid ad, which would appear at the top of Google search pages, failed to include any risk information about the drug, simply positing that the med “may be the solution you’re looking for.” The letter also notes that ProCentra was misbranded because the ad did not include the established name, ProCentra (dextroamphetamine sulfate).

RELATED: Careful, reps: Doctors are watching, FDA promo police's latest rebuke shows

The FDA specifically noted the pediatric target audience for the drug in the letter, writing, “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.”

But Outlook’s misstep is not uncommon, Ian Orekondy, founder and CEO of pharma-focused SEM compliance monitoring company AdComplyRx, said by email. AdComplyRx data shows that 40 other prescription drugmakers have inadvertently been running non-compliant search engine marketing ads this year. The complexity in ad platforms like Google Ads and Doubleclick Search makes it “easy” to make a mistake in URL placement, for instance, that could result in a noncompliant ad, he said.

RELATED: Two November warning letters put FDA ad police on cusp of double-digit reprimands for 2019

The FDA letter is the first smackdown in search engine marketing since 2014 but it shows the agency hasn’t forgotten about it.

“This warning letter demonstrates that the FDA continues to monitor the search engine marketing (SEM) landscape for non-compliance and take enforcement action when branded search ads make a benefits claim without including safety information,” Orekondy said.

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