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

Alex Tabarrok: COVID-19 Interview

A discussion on the COVID-19 pandemic, with Alex Tabarrok, Professor of Economics at George Mason University. Listen to the Policy@McCombs podcast to learn more about the data shaping public policy and the data that should be. Subscribe to our YouTube Channel to watch video versions of the podcasts.Salem Cente

To Serve and Collect: The Fiscal and Racial Determinants of Law Enforcement

We exploit local deficits and state-level differences in police revenue retention from civil asset forfeitures to estimate how incentives to raise revenue influence policing. In a national sample, we find that local fine and forfeiture revenue increases faster with drug arrests than arrests for violent crimes. Revenues also increase faster with arrests of blacks and Hispanics than with whites’ drug arrests. Concomitant with higher rates of revenue generation, we find that arrests of blacks and Hispanics for drugs, driving under the influence, and prostitution, and associated property seizures, increase with local deficits when institutions allow officials to more easily retain revenues from forfeited property. Whites’ drug and driving under the influence arrests are insensitive to these institutions. We do, however, observe comparable increases in whites’ prostitution arrests. Our results show that revenue-driven law enforcement can distort police behavior and decision-making, altering the quantity, type, and racial composition of arrests

To Serve and Collect: The Fiscal and Racial Determinants of Law Enforcement

We exploit local deficits and state-level differences in police revenue retention from civil asset forfeitures to estimate how incentives to raise revenue influence policing. In a national sample, we find that local fine and forfeiture revenue increases faster with drug arrests than arrests for violent crimes. Revenues also increase faster with arrests of blacks and Hispanics than with whites’ drug arrests. Concomitant with higher rates of revenue generation, we find that arrests of blacks and Hispanics for drugs, driving under the influence, and prostitution, and associated property seizures, increase with local deficits when institutions allow officials to more easily retain revenues from forfeited property. Whites’ drug and driving under the influence arrests are insensitive to these institutions. We do, however, observe comparable increases in whites’ prostitution arrests. Our results show that revenue-driven law enforcement can distort police behavior and decision-making, altering the quantity, type, and racial composition of arrests