GAO Criticizes the FDA’s ability to Oversee Clinical Trials

According to this post on outsourcing-pharma.com, the US Department of Health and Human Services has identified that the FDA has failed to provide sufficient oversight to ensure the protection of patients participating in clinical trials. This has in turn caused the GAO to conduct its own investigation of the FDA’s ability to oversee clinical trials, which started in 2007. The GAO is highly concerned that the FDA is not analyzing the impact age has on the safety and efficacy of the drug when the drug generally treats conditions for the more elderly.

Senator Criticizes Transparency Laws in Clinical Trials

According to this article on outsourcing-pharma.com, Senator Richard Moore has criticized laws in Massachusetts that enable pharma companies to hide payments made to physicians conducting clinical trials.

Moore believes that gifts and monetary compensation is public information and that it should not be hid from everyone. Moore later mentions:

“Patients and consumers generally have no idea what kind of relationships exist between their doctors and pharmaceutical companies or medical device manufacturers, relationships that result in billions of dollars per year in payments to health care practitioner.

Do you think that payments for physicians conducting clinical trials should be hid?

People in the Move in the Clinical Trials Industry

This latest article one outsourcing-pharma.com reports some very important changes in personnel within the clinical trials industry. Some changes include GVK Biosciences appointing Dr. Shoibal Mukherjee to the post of senior vice president, clinical development, and The appointment of Joerg Reinhardt as chief operating officer of Novartis. There are plenty more changes, you can read the full article here.