Drugmakers: Prepare for a Smackdown

For years the Food and Drug Administration has failed to adequately monitor the pharmaceutical industry. That conclusion by a special committee at the Institute of Medicine in a September 2006 report titled “The Future of Drug Safety” helped prompt a sweeping reform bill that became law last September. The Food and Drug Administration Amendments Act of 2007 gives the FDA the dollars and legal clout it needs to make a number of important fixes. Its key provisions and other new initiatives include these: