Pharmaceutical Companies and Compliance – The Many Levels of Enforcement

Compliance and quality go hand in hand. You can’t ignore one and expect the other. Pharmaceutical companies take compliance very seriously; it would be unreasonable to question whether or not they do. However, because compliance is a broadly encompassing term that in isolation is ambiguous, a better question to ask is, “Which aspects of compliance are taken seriously by sponsors and which are not?”
[Read more…]

Clinical Trial Data Sharing: Landscape, Trends, and Risks

The Clinical Trial Data Sharing Landscape
The potential benefit of sharing clinical trial data (patient-level data and clinical documentation) has been recognized by various industry groups over the past several years, but the reality of sharing data is emerging. While several successful initiatives have launched, e.g. the Coalition Against Major Diseases (CAMD), and contributed to the cumulative trend to share data, recent industry commitments and policy decisions have propelled this effort in a significant way.
[Read more…]

The Efficiency of Bringing Drugs to Market Versus the Fairness of Making Drugs Accessible

As the 2014 Ebola outbreak continues to spread in West Africa, drug companies, national governments, and public health entities as a whole are coming under increasing criticism for failing to offer what many would view as equitable approaches to addressing public health epidemics, particularly those occurring in poor or developing nations. Indeed, public health threats like the Ebola virus challenge drug companies to find the right balance between making unproven treatments available to desperate populations and ensuring the safety and efficacy of treatments that have yet to undergo comprehensive clinical testing. Furthermore, striking such a balance highlights a medical ethics issue that has haunted some of these drug companies in the past: conducting clinical trials on foreign populations with few of the ethical and safety protections required by western cultures, yet then pricing drugs out of the market for these same populations once they are FDA approved.
[Read more…]