iIn July, President Obama signed into law the FDA Safety and Innovation Act ("FDASIA"), a user-fee act intended to provide the Food and Drug Administration ("FDA") with resources to facilitate drug and medical device approvals. Although all the provisions of the FDASIA support acknowledged public benefits, the pharmaceutical intellectual property community might consider the gem of the act to be the provisions constituting the "Generating Antibiotic Incentives Now," or "GAIN" Act.
The GAIN Act was designed to stimulate pharmaceutical companies' development of innovative antibiotics to treat infections resistant to conventional antibiotics. Antibiotics have unquestionably saved countless lives, but their use and misuse have driven the rise of antibiotic-resistant variants at a huge cost. The cost of combatting the most widely known highly dangerous "superbugs," including methicillin-resistant Staphylococcus aureus ("MRSA"), has been estimated to be in the billions. Nevertheless, the pharmaceutical industry has not been active in developing new antibiotics to meet these changing needs — likely due to the products' general unprofitability (relatively low price, short timeline of use and expense to obtain approval).
The GAIN provisions encourage innovation in combatting antibiotic-resistant pathogens by making New Drug Applications (NDAs) for a drug designated a "qualified infectious disease product" ("QIDP") — where QIDP is an antibacterial or antifungal drug for human use for serious or life-threatening infections such as an antibacterial or antifungal resistant pathogen or specifically identified pathogens such as MRSA, vancomycin-resistant Staph. aureus or enterococcus, multi-drug resistant bacteria including Acinetobacter species, multi-drug resistant tuberculosis and Clostridium difficile — eligible for major incentives. The incentives for filing a QIDP NDA include: (a) FDA priority review, (b) fast track status, which could reduce the standard 12-month review to eight months, and (c) market exclusivity of five years in addition to the current five years of exclusivity for an NCE — without regard to patent status. Since GAIN's enactment in July, several companies have already taken advantage of its provisions, including Rib-X with its delafloxacin and PolyMedix with brilacidin, both being developed for use against MRSA.
The dozens of proponents of the GAIN Act believe its provisions will effectively combat the reluctant development of these products. There remain questions, however, as to whether GAIN will provide sufficiently meaningful incentives. Some commentators have suggested that GAIN's incentives do not overcome the lack of product profitability for short-term products. Others opine that the definition of QIDP is insufficiently broad.
Other provisions of the FDASIA (which passed both houses of Congress with bipartisan majorities) will provide the FDA with additional tools needed to continue to bring drugs and devices to market safely and quickly by accelerating approval of generic drugs, funding the approval pathway for biosimilar biologics, enhancing the ability of the FDA to counter drug shortages, enhancing the safety of the drug supply chain, and renewing mechanisms to ensure that children's medicines are appropriately tested and labeled.
The five additional years of exclusivity and faster track to approval are significant incentives provided by GAIN. When added to any exclusive rights available for a patented product, the GAIN provisions of the FDASIA appear to provide sufficient encouragement for at least smaller innovators.
