The Conference Committee released the PDUFA V bill text late Monday. The structure of the GAIN Act is unchanged – 5 years of additional exclusivity for qualifying infectious disease products.
2 good things about the new version: (1) it follows the Senate on the definition of qualifying infectious disease products, giving the FDA some leeway to consider impact on human health before making a designation; (2) HHS will present a full review of the program after 5 years, including recommendations for antimicrobial stewardship (why wait 5 years?)
2 disappointing elements: (1) the antibiotics prize study (Sect. 906 in the Senate Bill) was stripped out; and (2) the unsuccessful Priority Review Voucher program was extended to rare pediatric diseases, following the House.
Congress continues to be enamored with IP strategies for antibiotics, refusing to even think about de-linkage mechanisms like prizes or value-based reimbursement. Meanwhile, in Europe, the Lancet reports that money is flowing directly to antibiotics researchers without lengthening patent and exclusivity terms.
Previous TIE coverage here.