Recently Enacted Law Offers New Exclusivity Incentives for Drugs Containing "Old" Antibiotics

Recently Enacted Law Offers New Exclusivity Incentives for Drugs Containing "Old" Antibiotics

News
On October 8, 2008, President Bush signed into law S. 3560, the QI Program Supplemental Funding Act of 2008 (Public Law Number 110-379), which, among other things, amends the Federal Food, Drug, and Cosmetic Act (FDCA) to create new exclusivity opportunities for drug products containing "old" antibiotic ingredients. S. 3560 reverses certain provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA) that exempted products containing "old" antibiotics from the Hatch-Waxman provisions regarding marketing exclusivity and the patent listing and certification process. The new law accomplishes this in different ways for different categories of "old" antibiotics. For more, see our recent Email Alert.