The U.S. Food and Drug Administration recently announced sending warning letters to firms responsible for two popular e-cigarette products and issued draft guidance relating to diabetes drug efficacy.
The FDA released a draft industry directive May 25 titled "Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products Guidance for Industry." The document provided a 15-year update to the FDA's earlier recommendations on effectiveness endpoints for antidiabetic medications, according to a May 26 news release.
“Diabetes is a common disease that affects nearly 40 million people in the U.S. and is projected to affect more in the coming years," Lisa Yanoff, deputy director of the Office of Cardiology, Hematology, Endocrinology and Nephrology at the FDA’s Center for Drug Evaluation and Research, said in the release. "The need for more antidiabetic treatment options is clear. Today’s draft guidance demonstrates the FDA’s ongoing commitment to providing industry with up-to-date recommendations on how to approach developing new drug therapies.”
The FDA's recommendations on the effectiveness of antidiabetic medications for adults and children with type 1 and/or type 2 diabetes are outlined in the draft guidance, according to the release.
The average blood sugar measurement hemoglobin (A1C) is "still a valid primary efficacy objective, but when coupled with either a decrease in or maintenance of an acceptable A1C, the FDA now views a reduction in the risk of hypoglycemia (low blood sugar) as "a therapeutically relevant outcome metric for diabetic medication clinical studies," the release reported.
Additionally, letters were sent to Shenzen Innokin Technology Company, which makes Esco Bars, and Breeze Smoke LLC for concerns of violating the the Federal Food, Drug and Cosmetic Act, which forbids the production, distribution or importation of tobacco products without FDA approval, the release reported.
"Given their appeal to youth, these products are a priority for FDA compliance and enforcement action," the release said. "The FDA remains steadfast in its commitment to protecting youth from the harms of tobacco products by ensuring illegal products are not marketed, distributed or sold. These efforts include ongoing surveillance of the marketplace to identify violative products, including e-cigarettes."
