Investors from the biotech accelerator Haus Fund alongside telehealth brand Hims & Hers are advocating for domestic peptide production to counter the unregulated global gray market. A controversial interim policy from the Department of Health and Human Services permits certain unapproved peptides for compounding, offering an opening for local supply chains. Despite this, career Food and Drug Administration scientists warn there is insufficient evidence proving these substances are safe or effective. Experts also emphasize that onshoring faces massive hurdles, given that 51 percent of U.S. prescription active ingredients come from India and the European Union, while China supplies 10 percent.
Key points
Onshoring proponents argue domestic manufacturing will better protect consumers from unve…: Onshoring proponents argue domestic manufacturing will better protect consumers from unvetted overseas research peptides originating largely from China.
The domestic push exploits an interim Department of Health and Human Services policy allo…: The domestic push exploits an interim Department of Health and Human Services policy allowing compounding pharmacies to use certain unapproved peptides.
Industry experts warn that bypassing standard clinical trials risks establishing an under…: Industry experts warn that bypassing standard clinical trials risks establishing an underregulated parallel drug market amidst deeply entrenched global supply chains.
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Meet the people who want peptides to be made in America
For some, the answer to a dodgy gray market is to bring the pharmaceutical supply chain back to American soil.
The SS Jeremiah O’Brien is a World War II Liberty ship. The hulking vessel was built in 56 days. It made 11 trips to Normandy, France, to supply the Allied powers in the fight against German U-boats. Last week, it was the site of a black-tie peptide party thrown by a trio of Gen Z venture capitalists.
Roughly 150 people attended the event, where four types of peptide samples were provided to guests — no injections. One was a topical cream with GHK-Cu, while the other three were dissolvable sublingual strips from peptide startup Afterglow. GHK-Cu is a popular skincare…
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