The Food and Drug Administration Confronts Homeland and National Security: Report on a Workshop of the RAND Center for Domestic and International Health Security

On December 19, 2002, the RAND Center for Domestic and International Health Security hosted a workshop on the challenges the U.S. Food and Drug Administration (FDA) faces as a result of the chemical and biological threats of international terrorism to domestic and overseas U.S. targets: people and organizations, civilian and military. Awareness of these threats was dramatically heightened by the September 11, 2001, attacks on the World Trade Center and Pentagon and by the distribution of anthrax through the U.S. postal system in fall 2001. Awareness of chemical and biological threats was reinforced in late 2002 by the then prospect of armed conflict in Iraq and the knowledge that Saddam Hussein had used chemical weapons previously against Iran and on his own people. It was widely, but not universally, believed that Iraq had both chemical and biological warfare weapons and capabilities. The workshop originated from several sources. From 1997 to 2000, RAND conducted an extensive review of the scientific literature related to the risk factors identified as potential causes of Gulf War illnesses. A related report examined the Interim Rule that FDA adopted in late 1990 at the request of the Department of Defense (DoD), authorizing the Commissioner of Food and Drugs to waive the informed consent requirement governing the use of Investigational New Drugs (INDs) in certain military situations. Recently, RAND examined the interactions between DoD and FDA regarding the acquisition of drugs and biologics for defense against chemical and biological warfare agents, focusing primarily on how DoD ought to respond to FDA. As a result, RAND commissioned a paper by Gail H. Javitt to address how FDA might respond to increased national and homeland security needs for drugs and vaccines. The Javitt paper provided the point of departure for workshop discussion. The larger stimulus to the workshop was the limited availability of vaccines to protect both military personnel and civilian populations against such biological agents as anthrax and smallpox. The concern for vaccine availability also raised the issue of the adequacy (or inadequacy) of the industrial base. This industrial base issue has been debated within DoD for some time in terms of the advantages and disadvantages of having a government-owned, contractor-operated (GOCO) vaccine production facility. It has been addressed in other venues as well. Most notably, in 2002, the Council of the Institute of Medicine recommended the creation of a National Vaccine Authority. That same year, the Gilmore Commission recommended creating a GOCO for vaccines. In this context, workshop participants agreed that FDA regulation was an important piece of a much larger picture. Accordingly, workshop discussion focused on how FDA might modify its policies and procedures to make drugs and biologics, and especially vaccines, more readily available. However, a tension ran RAND RESEARCH AREAS