New US bill would provide exclusivity add-on for significant drug combos

Legislation co-sponsored in the USA by Representatives Brian Bilbray (Republican, California), Carolyn Maloney (Democrat, New York) and Rosa DeLauro (Democrat, Connecticut), and supported by the Melanoma Research Foundation, seeks to encourage the development of so-called “significant drug combinations” by offering the carrot of an extension of marketing exclusivity.

HR 6502, the Life-Threatening Diseases Compassion through Combination Therapy Act of 2012, was recently introduced and appears to be modeled after the Generating Antibiotic Incentives Now Act (GAIN Act), which was enacted under Title VIII of the FDA Safety and Innovation Act (FDASIA), notes Kurt Karst, writing on the Hyman, Phelps & McNamara FDA Law Blog.

The GAIN Act, which is intended to encourage the development of antibacterial and antifungal drug products that treat pathogens that cause serious and life-threatening infections, amended the FDC Act to add Section 505E to, among other things, grant an additional five years of marketing exclusivity upon the approval of a New Drug Application for a drug product designated by the Food and Drug Administration as a Qualified Infectious Disease Product. (FDA recently granted the first GAIN Act designation and there have already been winners and losers as a result of the new law, says Mr Karst.