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.
Caution is once more the watchword.
From an economic perspective, the risk to the individual of serious or even life-threatening effects should be traded against the disbenefit of slowing the advent of new drugs to the market. From an ethical standpoint, risk of serious effects to even a tiny minority of patients might be unacceptable. Risk evaluation is, of necessity, a long-term process. As drugs are tested on larger and larger numbers of patients in clinical trials, the chance of discovering unwanted side-effects increases. One possible shorter-term option would be to limit reform efforts to trying to improve FDA administrative procedures and management, with a view to further cuts in drug approval times.