FDA approval, postmarketing surveillance may provide data on relapse rates, drug substitution, and increased sensitivity to the abused drug after sustained treatment, events that may increase the potential for accidental drug overdoses (Kosten and Kranzler, this volume). Overall, these surveillance activities, as well as NIDA-funded health services studies, may offer substantially better data than the traditional clinical trials on the use of these immunotherapy and sustained-release medications in real-world situations. These studies could be conducted in the NIDA Clinical Trials Network.
In view of the strengths and limitations of data from clinical trials to support approval by the FDA for a specific indication, several issues will be particularly important during testing and postmarketing surveillance: NIDA’s working collaboratively with the FDA to test and monitor the immunotherapy medications; NIDA’s role to ensure commercial development of these immunotherapies; uses with a variety of special populations; prevention studies; and potential off-label uses after FDA approval.
It will be important for NIDA and the FDA to work together to establish guidelines for testing and monitoring immunotherapy and depot medications in the general medical community, where off-label use is quite likely. Mechanisms for achieving this cooperation might include reconstituting the FDA Drug Abuse Advisory Committee and conducting joint workshops that involve consultants from outside NIDA and the FDA.
A second key issue involves NIDA support for clinical trials and commercial development through established mechanisms. This is particularly important in light of the barriers to the development of pharmacotherapies for drug abuse, as well articulated in a recent report on addictions medications development (Institute of Medicine, 1998). Established mechanisms to support these efforts include at lest four funding programs: Cooperative Research and Development Agreements, Small Business Innovation Research, Small Business Technology Transfer, and Strategic Program for Innovative Research on Cocaine (and Other Psychomotor Stimulants) Addiction Program. These grant programs have facilitated very productive partnerships among small businesses, such as biotechnology companies, academia, and the federal government. Products have included active vaccines, monoclonal antibodies, and depot medications.