Last week the Pew Prescription Project, an arm of the Pew Charitable Trust, released a report on the risks of substandard and counterfeit drugs. This is a meticulously researched report that will likely be used by legislators and regulators to better understand the problems and potential solutions of U.S. pharmaceutical supply chain security. For this reason it is a must-read for anyone interested in the topics that RxTrace routinely explores. You can get a copy of the full report PDF, view the associated webcast and graphic here: After Heparin: Protecting Americans from the Risks of Substandard and Counterfeit Drugs. I’ll have more to say about the webcast in a subsequent essay.
According to the “Introduction and Background”,
“The U.S. Congress, the U.S. Food and Drug Administration (FDA), the pharmaceutical industry and other organizations have renewed their commitments to remedy existing weaknesses. This white paper seeks to inform these efforts by presenting a holistic picture of the pharmaceutical supply chain and its problems (illustrated by case studies), and to propose a set of meaningful reforms that will better protect patients.”
The report is 77 pages of text with 24 additional pages of references. The text is peppered with numbered references for those who want more details on a particular topic.
There are three Chapters.
- Pharmaceutical Manufacturing: Globalization and Quality Management
- Barriers to FDA Oversight
- Pharmaceutical Distribution
Chapter 1 contains Continue reading Pew Prescription Project: After Heparin