Regulating Access to Developmental Drugs for Terminally Ill Patients: Abigail Alliance v FDA

This amicus brief was filed in support of the Abigail Alliance for Better Access to Developmental Drugs in their lawsuit to force the Food and Drug Administration to provide patient access to drugs for cancer and other life-threatening illnesses after those drugs have passed through phase 1 clinical testing and have received FDA approval to enter additional clinical trials as a basis for eventual FDA approval for marketing. We make three arguments: (1) FDA staff face strong incentives to be too cautious in approving new drugs. As demonstrated by experience in cancer drug testing, patients often face a situation in which high-quality data from phase 1 clinical trials strongly indicate that a drug's benefits probably exceed its risks. (2) Permitting terminally-ill patients to access potentially life-saving post-phase-1 drugs still in testing will not unduly discourage patient participation in additional trials or inhibit post-phase- randomized clinical trials needed to obtain FDA approval. This is evident from the widespread and growing phenomenon of post-approval randomized clinical trials of approved drugs. (3) For similar reasons, it is clear that permitting terminally-ill patients to access potentially life-saving post-phase-1 drugs in testing will not discourage manufacturers from conducting additional randomized clinical trials.Health and Safety, Other Topics

UNCERTAINTY, RISK AVERSION, AND OPTIMAL DEFENSE AGAINST INTERRUPTIONS IN SUPPLY

Recent international conflicts have resurrected concerns about how to manage supply disruptions or sudden escalation of need for energy, and other critical imports such as vaccines or military components. Prominent proactive measures include support of domestic production and accumulation of reserves or maintenance of stand-by production. This paper develops a clear transparent method for comparing instruments and for identifying the optimum policy mix. We show how a country's risk aversion influences the best mix of policies and interacts unexpectedly with the degree of risk itself. Specifically, high-risk aversion and low risk are shown to favor domestic production support as the better defense, and to disfavor stockpiling (and vice versa). In clarifying a country's best policy response to risks of supply interruption, this analysis predicts how income level and risk aversion characteristics should shape arguments for and against interference with free trade on grounds of 'national security.'Stockpiles, Risk Management, Embargo Protection, Risk Aversion, Emergency Preparations,

PROTECTING CULTURAL MONUMENTS AGAINST TERRORISM

Famous cultural monuments are often regarded as unique icons, making them an attractive target for terrorists. Despite huge military and police outlays, terrorist attacks on important monuments can hardly be avoided. We argue that an effective strategy to discourage terrorist attacks on iconic monuments is for a government to show a firm commitment to swift reconstruction. Using a simple game-theoretic model, we demonstrate how a credible claim to rebuild any destroyed cultural monument discourages terrorist attacks by altering the terrorists' expectations and by increasing the government's reputation costs if they fail to rebuild.Terrorism, Culture, Monuments, Counter-terrorism, Deterrence,