FDA’s Handling Of Authority To Regulate Compounding Sparks Growing Chorus Of Criticism
The FDA has found itself pulled in many different directions as Congress, drugmakers and industry weigh in on compounding, the science of preparing personalized medications for patients.
Stat:
Congress Ramps Up Its Scrutiny Of Drug Compounding, Putting FDA In A Bind
It’s been five years since Congress gave FDA sweeping authority to regulate compounding, but lawmakers — many of whom wrote that law — still don’t think FDA is properly regulating the growing industry. The problem is, lawmakers can’t seem to agree on the tack the agency should take. And they’re not the only ones pulling FDA in different directions. (Florko, 10/10)
In other news involving the FDA —
Stat:
McKesson Failed To Follow Procedures When Notified Of Illegitimate Products
Amid regulatory concerns over counterfeit medicines, one of the largest U.S. wholesalers failed to follow proper procedures after being notified by customers that illegitimate products had been shipped, according to a recent inspection by the Food and Drug Administration. Specifically, McKesson (MCK) failed to identify and then quarantine “suspect or illegitimate” products. The wholesaler also did not retain samples or promptly notify other customers there was reason to believe illegitimate products were shipped. (Silverman, 10/9)
Stat:
Questions About Funding, Purpose Loom Over An FDA-Affiliated Foundation
A little-known nonprofit established by Congress over 10 years ago to help the Food and Drug Administration work with the private sector is still struggling with a basic question: Where is the cash? The Reagan-Udall Foundation for the FDA is supposed to act as a liaison between the FDA itself and drug companies, researchers, nonprofits, or other businesses with regulated products who might want to support a project to make the agency’s job easier. It has raised just under $15 million during its first decade, according to the foundation. (Swetlitz, 10/8)
