VT Compounder Hit With FDA Enforcement

District Court Enjoins Vermont Pharmacy from Distributing Drugs Not Made in Compliance with Federal Food, Drug and Cosmetic Act
Department of Justice press release, June 13, 2022
- A federal court permanently enjoined a Colchester, Vermont, compounding pharmacy from distributing drugs unless they are manufactured in compliance with the Federal Food, Drug and Cosmetic Act (FDCA), the Justice Department announced.
In a complaint filed May 20, the United States alleged that Edge Pharm Inc., and its owners and operators Marc Chatoff and Kurt Radke, violated the FDCA by manufacturing and distributing adulterated and misbranded drugs, by causing drugs to become adulterated and misbranded while held for sale, and by introducing new unapproved drugs into interstate commerce.
According to the complaint, the defendants manufactured injectable drugs intended to be sterile under conditions that fell short of the minimum requirements to ensure sterility. The complaint further alleged that U.S. Food and Drug Administration (FDA) inspections of the Edge facility between 2014 and 2021 revealed record-keeping violations, labelling inadequacies, improper airflow, structural disrepair and the presence in cleanroom suites of mold species that can cause diseases in humans which may be deadly to immunocompromised patients.
“Edge Pharma LLC has put patients’ lives at risk by repeatedly producing drugs under insanitary conditions and failing to follow good manufacturing practice requirements,” said Director Donald Ashley of the Center for Drug Evaluation and Research (CDER) Office of Compliance.
“While compounded drugs are not FDA-approved, all drug firms must prioritize patient safety, which Edge Pharma has been unable to do. This consent decree ensures that Edge Pharma will be held accountable, and FDA will continue to take all necessary steps within our regulatory authority to protect the health of the American public.”

Last Lewis Post

Terri's last post Chemo2 today. It's been a very long day beginning with a port that had a blockage that we finally got cleared. I had an adverse, unexpected reaction to the chemo. We worked through it, learned what to do for next time. I have very low sodium, a bladder infection, and am generally wiped out by the intensity of all of the events of this day. But we got the tumor genetics back and now know exactly what we're dealing with to target for immune therapies. Pharmacogenetics and prescriptions macrobid and more salt ya'll. My thanks to the awesome oncology team at SLC cancer center in Butte. Throughout it all, they were on top of things and didn't miss a beat.

Cadden's Michigan Appeal Denied

The Michigan Supreme Court has denied an appeal by a former pharmacist who will now face a jury on charges of 11 counts of second degree murder.
In a brief order issued today the state's highest court upheld a prior order issued by the state Court of Appeals which found that Barry J. Cadden should go before a Livingston County jury to face the charges brought by the state Attorney General.
Both Cadden and co-defendant Glenn A. Chin were charged for their roles in the 2012 fungal meningitis outbreak which ultimately took the lives of more than 100 patients.
Cadden was president and part owner of the New England Compounding Center, the company that shipped thousands of contaminated vials of a steroid which was injected into unsuspecting patients. Chin was the supervising pharmacist in the clean room where the tainted drugs were produced.
The two already have been convicted on related federal charges, but two separate juries declined to convict them on second degree murder charges. The Michigan Attorney General subsequently filed murder charges on the deaths of 23 Livingston County patients.
The Supreme Court already has denied a parallel appeal filed by Chin. Both Cadden and Chin will now go before Livingston County Judge Michael Hatty to face trial. They had argued that the Attorney General had failed to provide sufficient evidence for the charges to be presented to a jury.
Contact :wfrochejr999@gmail.com

Terri Lewis.. The Ever Advocate, Passes Away

Terri Lewis, the ever advocate for victims of the 2012 fungal meningitis outbreak, has passed away from Cancer..
Lewis died Sunday, not long afterbshe was diagnosed with cancer. She has helped hundreds of outbreak victims get needed care even after they had been abandoned by their medical providers..

60 Minutes Segment on Drug Supply Manipulation

FYI https://mail.google.com/mail/u/0/#inbox/FMfcgzGpFzzdLZSvlfGcCZfxzmDfRDvd

Chin's Michigan Appeal Denied

By Walter F. Roche Jr.

The Michigan Supreme Court has rejected an appeal filed by a former pharmacist seeking to have multiple second degree murder charges thrown out.
In a one paragraph ruling the state's highest court rejected Chin's claim that there was insufficient evidence for the charges to be presented to a Livingston County jury.
"We are not persuaded that the question presented should be reviewed by this court," the ruling states. Chin was a supervising pharmacist at a Massachusetts drug compounding firm that shipped thousands of vials of a contaminated steroid to health facilities across the country.
Over 100 patients, including 11 in Michigan, died after injection with the drug ladened with a deadly fungus.
Chin was appealing a decision by the state Court of Appeals which rejected a similar plea to have the murder charges tossed. The case has been bouncing back and forth between the two courts since last year.
The decision means Chin will face the charges before a jury in Livingston County. The case is being prosecuted by the Michigan Attorney General's office.
A parallel appeal has been filed by co-defendant Barry Cadden, who was president and part owner of the same compounding firm, the now defunct New England Compounding Center. Cadden's appeal is still pending.
Contact: wfrochejr999@gmail.com

Chin Seeks 2.5 Year Sentence Reduction

By Walter F. Roche Jr.

The lawyer for a former pharmacist facing a 10.5 year prison term argued today in a federal apppeals court hearing that a U.S. District Court judge erred when he tacked on another 2.5 years to his sentence for racketeering and related charges.
James Sultan, the lawyer for Glenn Chin, the former pharmacist, told a three judge panel that his client had no way of knowing that the drugs he was preparing contained a deadly fungus.
Chin was the supervising pharmacist at the now defunct New England Compounding Center, the company blamed for the 2012 fungal meningitis outbreak which ultimately took the lives of more than 100 patients. Arguing in the 1st Circuit Court of Appeals in Boston, Mass., Christopher Looney, representing federal prosecutors, said the outbreak victims represented the very definition of vulnerable victims and the 10.5 year sentence should remain in place.
Looney also argued that Chin clearly knew or should have known that the drugs he was preparing could, if contaminated, lead to death or serious injury.
Sultan, however, stated that Chin had been preparing the same drug, preservative free methyl prednisolone acetate, for years without incident.
Chin and co-defendant Barry J. Cadden, are currently awaiting trial in Livingston County Michigan on multiple charges of second degree murder in the deaths of 11 patients who were injected with the same spinal steroid.
The Michigan Supreme Court yesterday denied Chin's motion to have the second degree murder charges thrown out. (See related story) The 10.5 year sentence was set by U.S. District Court Judge Richard G. Stearns after the same appeals court concluded that the original eight year sentence set by Stearns was too lenient. But in today's hearing Looney was asked whether Stearns might have over-read their prior ruling.
Looney responded stating that Chin was aware of the risks involved in injecting drugs into a patient's spinal column.
He cited the trial testimony of a former NECC employee who recounted a conversation he had with Chin in which the risks of such injections were discussed.
Following 45 minutes of arguments, the panel took the case under advisement.
Contact: wfrochejr999@gmail.com