Gabrielle Cosel

Expert Profile: Gabrielle Cosel

Gabrielle Cosel, Project Manager, Drug Supply Safety

''FDA calls for more congressional oversight on global drug economy''

"The Food and Drug Administration called on Congress Tuesday to make the laws that govern the global prescription drug economy stronger. In a report released Tuesday by the Pew Health Group, researchers looked at the globalization of pharmaceutical production and the domestic distribution of prescription drug, with an eye on how the FDA can more effectively regulate both."

Heparin: A Wake-Up Call on Risks to the U.S. Drug Supply

While the vast majority of drugs in American pharmacies and medicine cabinets are safe, globalization and reliance on outsourced manufacturing creates new risks, including deliberate tampering with ingredients and inadequate quality controls in plants that operate largely outside the scrutiny of the FDA.

Case Studies: How Unsafe Drugs Can Reach Patients

The following case studies illustrate breaches to the pharmaceutical supply chain—the route a drug travels from its raw material origins to the delivery of a finished medicine. These examples, all of which are discussed in Pew Health Group’s report After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs, demonstrate the different ways in which contaminated, fake, or otherwise unsafe medicine can reach patients, and underscore the need for reform.

After Heparin

This report provides an overview of the complex pharmaceutical supply chain from manufacturing through distribution of the finished drug, and advances proposed policy solutions to help reduce the risks of counterfeit, adulterated and substandard drugs.

Read two fact sheets describing the heparin adulteration and other examples of breaches to the U.S. drug supply.

View an interactive graphic presenting an overview of today's globalized pharmaceutical supply chain and its vulnerabilities.