Letter to THE U.S. SENATE to Save Peptides, Specifically Thymosin Alpha 1

Letter to THE U.S. SENATE to Save Peptides, Specifically Thymosin Alpha 1 We ask our senators and congressmen to pass legislation allowing peptides to be compounded, used responsibly in a clinical setting and studied for patients willing to try this therapy which has been used safely abroad for decades. Background Peptides, currently defined by the FDA as short chains of 40 or fewer amino acids, have been used for decades in the US and abroad. Peptides have been shown to be safe, effective and non-addictive with no major side effects. In particular, Thymosin Alpha 1, discovered in 1972, has been approved and used in the US on a limited basis and in 35 other countries to treat a variety of conditions, including viral, bacterial and fungal infections. Current Situation In March, 2020, the FDA placed new restrictions on compounding pharmacies regarding the production and sale of peptides. On February 24, 2021, the agency banned compounding pharmacies from producing Thymosin Alpha 1 and prohibited this peptide’s use to treat any condition, including Covid-19. With over 500,000 American lives lost in the current pandemic, an urgent need exists to fill in the gaps in immunity left by those unwilling or medically unable to get vaccinated against Covid-19. There are 14 published studies showing that TA1 has benefits against Covid-19. Among those studies, three show that TA1 improves survival in patients critically ill with Covid-19. Real Danger to the Public Unsupervised individuals who order unregulated, impure substances online can waste resources and cause harm, even death. The FDA should focus its actions on peptides marketed in this environment but allow 503A and 503 B compounding pharmacies to produce and sell peptides, especially Thymosin Alpha 1. Petition Therefore, we ask our senators and members of Congress draft and pass legislation allowing 503A and 503B compounding pharmacies to produce peptides, especially Thymosin Alpha 1, based on their proven benefits in research and in years of clinical practice.