New Legislation Would Provide Exclusivity Add-on for Significant Drug Combinations
By Kurt R. Karst, FDA Law Blog
Legislation co-sponsored by Representatives Brian Bilbray (R-CA), Carolyn Maloney (D-NY) and Rosa DeLauro (D-CT), and supported by the Melanoma Research Foundation, seeks to encourge the development of so-called “significant drug combinations” by offering the carrot of an extension of marketing exclusivity.
H.R. 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”) (see here). 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 5 years of marketing exclusivity upon the approval of an NDA for a drug product designated by FDA as a Qualified Infectious Disease Product. (FDA recently granted the first GAIN Act designation – see here – and there have already been winners and losers as a result of the new law – see here.) Similarly, H.R. 6502 would amend the FDC Act – also to add Section 505E (and therefore, either an error/oversight, or perhaps an indication that the bill was in the works prior to the enactment of FDASIA) – to add 6-months of marketing exclusivity to 5-year new chemical entity exclusivity, 3-year new clinical investigation exclusivity, “or” 7-year orphan drug exclusivity for a drug product approved under an NDA and that contains a “significant drug combination” designated as such by FDA. The bill also provides for priority (6-month) review of an NDA for a drug product containing a designated “significant drug combination.”