Raising the Science Standard for New Drug Development

New drug development has sunk into a state of doldrums in spite of explosive advancement of basic research, especially in human genomics, and enormous investment from both government and industry. 2007 was the worst rate of new drug approvals in a quarter of a century in the U.S. experience. This book proposes raising the science standard for new drug approvals to end the "race to the bottom" the biopharmaceutical sectors are engaged in, and to enhance the role of the U.S. government in new drug development along the lines of the Manhattan Project and the Human Genome Project.

Michael J. Malinowski is the Ernest and Iris Eldred Associate Professor of Law and the Lawrence B. Sandoz, Jr. Endowed Professor of Law at the Paul M. Hebert Law Center, Louisiana State Uinversity. He received a B.A. summa cum laude from Tufts University and a J.D. from Yale Law School, where he was Articles Editor for the Yale Law Journal.