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Regulatory Focus™ > News Articles > OPDP Letters: FDA Closes Out 2017 With Record Low

OPDP Letters: FDA Closes Out 2017 With Record Low

Posted 03 January 2018 | By Michael Mezher 

OPDP Letters: FDA Closes Out 2017 With Record Low

In the last days of 2017, the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a warning letter to over-the-counter (OTC) drugmaker Avanthi, Inc. for omitting risk information in a panel for the weight loss drug Lomaira (phentermine hydrochloride USP).

The warning letter brings the total number of enforcement letters issued by OPDP in 2017 to four (three warning letters and one untitled letter), a record low for the agency.

While the number of OPDP letters sent each year has steadily declined since the late 90s, when the office routinely issued more than 100 letters per year, 2017 marks only the second time the office has issued fewer than 10 action letters.

In 2015, OPDP issued just nine action letters (two warning letters and seven untitled letters) and in 2016 the office issued 11 action letters (three warning letters and eight untitled letters) after a burst of six letters in the final weeks of the year.

Warning Letter

According to FDA, a panel sponsored by Avanthi that appeared in the exhibit halls of the Endocrine Society and American College of Cardiology's 2017 annual meetings left out any mention of Lomaira's risks.

The panel, which touts "flexible dosing options" and makes other promotional statements such as "The Power of Three," does not mention any of the drug's potential side effects, contraindications or warnings such as risk of abuse and dependence.

"By omitting the risks associated with Lomaira, including serious and potentially fatal risks, the panel fairs to provide material information about the consequences that may result from the use of the drug and creates a misleading impression of the drug's safety," FDA writes.

FDA also notes that Lomaira is only indicated for short-term use in patients with a body mass index of 30kg/m2 or greater than or equal to 27kg/m2, with other risk factors such as controlled hypertension, diabetes or hyperlipidemia.

In response, FDA calls on Avanthi to cease misbranding Lomaira and provide an action plan to disseminate "truthful, non-misleading and complete corrective messages" to the audiences that received the promotional materials.

FDA, Promotional Materials


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