OPDP Letters: FDA Closes Out 2017 With Record Low

In the last days of 2017, the Office of Prescription Drug Promotion (OPDP) of the US Food and Drug Administration. UU (FDA) has sent a warning letter to over-the-counter pharmacist Avanthi, Inc. to omit risk information on a panel for the Lomaira weight loss drug (Phentermine hydrochloride, USP).

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

While the number of letters sent each year by the OPDP has steadily declined since the late 1990s, while the office regularly published more than 100 letters per year, 2017 is the second time that the office has published fewer than 10 letters per year. 'action.

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

Warning letter

According to the FDA, a panel sponsored by Avanthi, which appeared in the exhibition halls of the 2017 annual meetings of the Endocrine Society and the American College of Cardiology, failed to mention the risks of Lomaira.

The panel, which advocates "flexible dosing options" and makes other promotional statements such as "The power of three", does not mention any possible side effects, contraindications or warnings of the drug, such as the risk of abuse and dependence.

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

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

In response, the FDA is asking Avanthi to stop labeling Lomaira and provide an action plan to broadcast "true, non-misleading and complete remedial messages" to the audiences who received the promotional material.