Urgent: Restore Access to Detemir Insulin Through FDA Compounding Pathway
A new manufacturer is making detemir insulin and it is currently being tested. It can be made available through a 503B outsourcing facility through compounding after the FDA gives the needed approval, uses enforcement discretion, and places detemir on the FDA Drug Shortage List.
This would be a private pay solution. Compounded products are not typically covered through assistance programs such as Medicare, Medicaid, or private insurance. This compounded version isn't available for use yet as regulatory barriers remain.
Background: The FDA offers a safety mechanism in the case of shortage of an essential medicine. The definition of a shortage is the demand of a pharmaceutical product exceeds the supply. Other discontinued products have been put on the FDA Drug Shortage List. Once a necessary drug is on the FDA drug shortage list, 503B outsourcing facilities can make them available through a faster pathway.
For example, the FDA identified a penicillin shortage in 2024. The FDA did not say there are alternative antibiotics in the U.S., rather the FDA acknowledged that some populations require penicillin. In light of this, the FDA worked with companies to bring penicillin powder from novel locations to provide penicillin in the U.S.
We are asking for similar consideration to permit us to have access to this unique basal insulin through the compounding pathway.
The most difficult part of this journey has been the lack of communication with the FDA. Some people are experiencing harm without detemir insulin. Some pregnant women are not able to achieve optimal blood glucose goals of an A1C under 6 or 6.5, recommended by the ADA for optimal pregnancy outcomes. Some physicians are having difficulty assisting their pregnant patients with the frequent need to change the amount of insulin given to match the often quickly changing insulin needs during pregnancy without flexible detemir. The alternatives are much longer acting and not well prove in pregnancy. Some are able to use the intermediate acting NPH, but others need access to detemir. The difficulty of longer acting basal insulins is especially evident at delivery when insulin needs often drop drastically.
In addition to pregnancy difficulties, some people are reporting dangerous "glargine lows," as well as additional adverse effects as Levemir supplies are running out.
There is a barrier to this necessary FDA approval pathway. Insulin was traditionally regulated as a drug under the Federal Food, Drug, and Cosmetic Act of 1938. In 2010, as part of the Affordable Care Act, it was decided that the designation of insulin would be changed in 2020 to being regulated as a biologic. Apparently the purpose was to increase competition but in reality this regulatory change hurt those who require detemir because it made a company working on a biosimilar unrealistic because the reference product is necessary for a biosimilar to be approved by the FDA. We have discussed the potential of developing a detemir biosimlar with multiple manufacturers and all have told us the biosimilar pathway is not feasible now that Levemir has been discontinued and there will no longer be a reference product to compare a biosimilar against.
Levemir was approved in the U.S. in 2005 and then discontinued in 2024, so it was regulated by the FDA as a drug from 2005-2020 and then as a biologic from 2020-2024. There is not a drug shortage pathway for biologics. We are asking the FDA and HHS to consider detemir a drug as it was initially approved and as it was regulated for 15 of the 19 years of its lifetime, and put on the FDA Drug shortage list so it can be compounded. We need this to sustain our lives.
Please help us advocate for FDA attention to this needed compounding pathway. Reach out to us by email: insulinchoice@gmail.com
or on our website: https://alliancetoprotectinsulinchoice.org/contact