CAPRA Blog

By 2010, approximately 400,000 women have received breast implants from the French company Poly Implant Prothèse. Little did they know at the time, those implants were ticking time bombs waiting to rupture. The fraudulent story of how PIP knowingly manufactured adulterated implants, alongside high-profile failures like the DePuy ASR hip and Guidant pacemakers, served as the catalyst for a fundamental shift in how the European Union (EU) regulates medical devices.

Although only 20% of all GCP inspections are conducted at sponsor sites, the majority of critical observations are identified there. In this analysis, 11 years of GCP inspections conducted by the GCP Inspector Working Group (GCP-IWG) from 2013 to 2023 were reviewed. The findings indicates that, from a sponsor’s trial management perspective, developing and implementing a robust data management and a monitoring plan can reduce the likelihood of receiving a critical deficiency by 60%.

In the U.S., the system designed to protect Americans from the financial devastation of illness often ends up being the very source of that devastation. While it can be debated whether healthcare is a basic human right or just another commodity, there’s no denying that it’s expensive. Without health insurance, very few Americans can afford to get sick, yet even with insurance, the burden of cost-sharing often forces people to delay or forego necessary care.

Drug pricing is a complex and controversial issue that often sparks debates among patients, pharmaceutical companies, and the government. Prices can vary significantly between countries, with drugs typically being the most expensive in the U.S., followed by Switzerland and Canada [1]. If the price of a new drug is too high, patients may struggle to afford it, either directly or through their public or private insurers.