There has even been speculation on possible legislation to require FDA to factor drug pricing into the regulatory framework. The FDA must be seen to impose the highest ethical principles in dealing with public health and safety issues. Given the pivotal commercial importance of new drug approval, the potential for bias in either drug discovery or clinical trials is obvious, and more widespread financial arrangements between corporate sponsors and academic scientists and clinicians have heightened public concerns. Cases of fraud by pharmaceutical company employees have reminded the public of the value of the FDA's policing role. Recently, the FDA proposed conflict of interest guidelines to provide oversight of financial ties between corporate sponsors and independent clinicians in academic centers.
Similar controls are under consideration for pre-clinical research scientists.
This is the most significant attempt at enhancing productivity. Approval of New Drug Applications offering substantial gain in the treatment of severe and life-threatening diseases has been accelerated. Despite attempts to speed up drug approvals, there are doubts about the amount of change the regulatory system can tolerate. Fast track drug development procedures introduced in the late 1980's and early 1990's to bring through new treatments for diseases such as AIDS and cancer are being reevaluated. Prompted by unexpected patient deaths, the FDA recently announced a further tightening of its procedures for submission of safety data for clinical trials.