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February 21, 2024
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Top in endocrinology: FDA warns about unapproved drugs; LillyDirect model raises concerns

The FDA has issued warning letters to US Chem Labs and Synthetix Inc. for offering unapproved and misbranded semaglutide and tirzepatide on their websites.

The two companies offered semaglutide and tirzepatide for sale on their websites “for research purposes,” but the FDA said the claims made about the drugs on both companies’ websites suggest that the products are intended for human use.

Source: Adobe Stock
The FDA recently sent warning letters to two companies for offering unapproved semaglutide and tirzepatide on their websites. Image: Adobe Stock

The FDA stated in both letters that the products being offered cannot be legally introduced into interstate commerce without FDA approval.

It was the top story in endocrinology last week.

Another top story was about LillyDirect, a new direct-to-consumer program offering care for diabetes, migraine and obesity.

The announcement of this program could be a turning point in how people acquire medications, according to Susan Cornell, PharmD, CDCES, FAPhA, FADCES, associate director of experiential education and professor in the department of pharmacy practice at Midwestern University College of Pharmacy in Downers Grove, Illinois, and a Healio | Endocrine Today Editorial Board Member.

However, other providers are concerned that the program could erode the patient-provider relationship.

Read these and more top stories in endocrinology below:

FDA issues warnings to two companies for unapproved semaglutide, tirzepatide

The FDA has issued warning letters to two companies for offering unapproved and misbranded versions of semaglutide and tirzepatide on their websites, according to a press release. Read more.

Direct-to-consumer model may improve drug access, but providers warn about possible biases

A new direct-to-consumer health care program launched by Eli Lilly has the potential to improve access to diabetes, obesity and migraine medications in the United States. Read more.

Most adults with obesity are not prescribed obesity medication

Most adults with obesity were not prescribed an obesity medication from 2015 to 2023, and of those prescribed an agent, 55% had at least one prescription fill, according to study data published in Diabetes, Obesity and Metabolism. Read more.

Iodized salt: Celebrating the centennial of a major US public health triumph

Just over a century ago, much of the U.S. population experienced disfiguring and debilitating disorders related to iodine deficiency. In 2024, we celebrate 100 years of salt iodization — a tremendous public health achievement. Read more.

Height and weight can be accurately measured remotely for children with obesity

Height and weight measurements collected through videoconferencing are highly correlated with in-person measurements and support the use of remote assessment of BMI for children with obesity, according to a brief report. Read more.