Update on the Availability of Peptides
Edwin Lee, M.D., and Luis Martinez, M.D.
The Clinical Peptide Society is aware of some recent FDA positions and actions which could severely restrict physicians’ prescribing of peptides and patients’ access to such important therapies. We are currently gathering additional information to better assess the situation and our response to it.
On April 2, 2020 Tailor Made Compounding received a warning letter from the FDA in response to the 2018 inspection of that pharmacy. As of today, April 8, 2020, we have not seen FDA Form 483 sent out to Tailor Made.
Speculation abounds concerning the future of peptides, and we feel that some peptides will be taken away. For instance, Cerebrolysin, a mixture of growth factors and peptides derived from young pigs’ brains, has been recently classified as a biologic. It appears that both growth hormone-releasing hormones and peptides are being restricted, and we feel that the pharmaceutical companies which deal with HGH are pressuring the FDA to impose these limitations. We are not sure what the future holds for other peptides. We suspect that some peptides will be available, like Thymosin Alpha 1, Thymosin Beta 4 and PT 141, but this is only our best guess.
In February, 2019 the FDA defined a peptide as having fewer than 40 amino acids. Anything above that number now constitutes a protein and a biologic. Tesamorelin, a 44-amino acid peptide, is now considered a biologic by the FDA. Thus, this substance cannot be compounded, even though it is FDA approved, unless the pharmacy has a biologic license. Compounding pharmacies are excluded from obtaining a biologic license.
This arbitrary FDA definition of a peptide is contrary to all the research and published data from the 1970s about what a peptide is. Most scholarly articles refer to peptides as having fewer than 100 amino acids. Insulin, consisting of 52 amino acids, is the most famous example of a peptide. Its discovery won the Nobel Prize in Medicine in 1923. With the new FDA definition for these substances, all the textbooks on endocrinology will need to be updated since insulin will no longer be a peptide.
What constitutes a biologic is debatable. Biologics are produced from living organisms or contain components of living organisms. On March 23, 2020 the FDA classified HCG as a biologic, so it can no longer be compounded. Three days later, Dr. Lee called the Center for Biologics Evaluation and Research at 1-800-835-4709 and asked whether HCG was categorized as a biologic. The FDA agent who works for this center replied that she did not consider HCG to be a biologic and had no idea why it was classified as one.
We as a professional society will do everything in our power to assure that peptides continue to be available through reputable compounding pharmacies so that physicians may continue to use these therapies as part of their armamentarium to help patients. However, the range of peptides will be limited, and not all the peptides that we once used will be available.
We will continue to update our members as the situation evolves. The only possibility for change is legislative action. Later on, we will mount a campaign so that all of us and our patients can petition our lawmakers to reverse this new ruling. If peptides compounded in a well-regulated, FDA-approved pharmacy are no longer available, then the huge demand for them on the dark side of the internet will be dangerous to our patients’ health.
Drs. Edwin Lee and Luis Martinez
Clinical Peptide Society
April 8, 2020