Exclusive: Dr. Michael C. Burgess: We Need a New Playbook to Guard Against Counterfeit Drug Ingredients from China
The Green List trusted the letterhead. The powder came from somewhere else.
Summary
- Breitbart published former Rep. Michael C. Burgess, a physician, warning that FDA's GLP-1 Green List still gives preferential border treatment to trusted foreign firms shipping unapproved active pharmaceutical ingredients, a trust he calls obsolete.
- FDA disclosed that Harbin Jixianglong Biotech, a Chinese Green List manufacturer, obtained unapproved semaglutide API from an off-list facility, relabeled it, altered manufacturing and retest data, and shipped it into U.S. commerce. FDA said the conduct may have been an attempt to get around Import Alert 66-80.
- In the August 2026 revision of that alert, FDA said it evaluated 48 sites making unapproved GLP-1 API and found 21 percent noncompliant. Some makers registered, refused records, then deregistered. Thirty-eight attorneys general warned FDA in February 2025 about counterfeit GLP-1 products from China, Turkey, India, and other sources.
- On August 27, 2026, the Fifth Circuit upheld FDA findings that shortages of Novo Nordisk's Ozempic and Wegovy and Eli Lilly's Mounjaro and Zepbound had ended. Novo reported capacity of about 5.8 million packages a month versus about 520,000 compounded packages. Burgess wants the Green List ended for unapproved foreign GLP-1 API and replaced with shipment-specific proof. The 2012 NECC fungal meningitis outbreak sickened more than 700 and was tied to at least 64 deaths.
Commentary
A night-shift dad still counts pills into a weekly box and knows a pen is supposed to be the dose on the label, not a relabeled crate from a plant nobody named. He did not pay the copay so a Green List stamp could hide the real floor.
Harbin relabel. 21 percent of 48 sites noncompliant. Shortage ruling upheld August 27. The honest household already paid the pharmacy. The linoleum at that counter still waits on a bottle that matches the print.
Look every working father who still writes a copay in the eye and answer this: if the letterhead already lied about the powder, who still owns the next vial that Green List lets through?
Comments
Harbin relabel. Green List. 21 percent fail. Keep that order.
I stood a line so a pill still meant the plant on the label. A trusted-firm stamp is not a lab test.
Import Alert 66-80. Fifth Circuit Aug. 27. 38 AGs. Print the three.
Allied inspectors still test the lot, not the stationery.
5.8 million vs 520,000. NECC 700 sick, 64 dead. File both.
I still clock a dock at 2 a.m. I want the next crate tied to a real floor, not a Green List name.
A relabeled Chinese API in a weight pen is not a bargain. It is a warning the street already paid.
A trusted-firm shortcut is a second border around a kitchen table. The first lot test should have been enough.
Breitbart printed Burgess, Harbin, and 21 percent. Argue those nouns.
Kill the Green List for unapproved API. Inspect the shipment. A letterhead is not a medicine.
