What a Failed Vegas Sex Pill and The Meningitis Outbreak Have In Common - ProPublica

What a Failed Vegas Sex Pill and The Meningitis Outbreak Have In Common - ProPublica

This could have been prevented. More than a decade ago, David Kessler, former FDA commissioner, issued a warning about the future of compounded drugs at a Congressional hearing prior to passage of the Food and Drug Administration Modernization Act of 1997. He said that ambiguity in the law could allow for “large scale manufacturing under the guise of pharmacy compounding,” leading to a “shadow industry” of unapproved generic drugs.

An Iv-B and Oy-R business caused by weak I-O regulation, it is like the shadow banking industry that led to the GFC. The FDC was not permitted to police it which is like Clinton and later Greenspan preventing regulation of derivatives. 

Provisions in the act designed to clarify FDA oversight of compounding pharmacies — including restrictions on their ability to advertise drugs — were later struck down by courts. Still, the FDA says it can act in some circumstances, such as when a drug is contaminated or mislabeled.

Miller said he believes only a few rogue compounding pharmacies are operating outside traditional boundaries. The New England Compounding Center “appears to have been acting as a manufacturer without being registered as a manufacturer with the (Food and Drug Administration), or registering with the Massachusetts Board of Pharmacy as a manufacturer,” he said.

“Something does need to change. That’s something our association is grappling with right now,” he said. In the wake of the outbreak, officials from the academy are in contact with congressional staffers to discuss how to increase oversight without stifling traditional pharmacy practices, Miller added.

Other cases have raised alarms. In 2007, a Portland Tribune investigation revealed patient deaths that were linked to a bad batch of drugs, used to treat back pain, from a Texas compounding pharmacy. A pharmacist who consults with the advocacy group Public Citizen called the compounding pharmacy industry a “shadow drug industry,” in an interview with the newspaper.

The Iv pharmacies and B patients create chaos between them, they interact with each other having no police or public Bi discussion to moderate their behavior so it grows to a ceiling and then crashes to a floor.