GAIN might accomplish two things. It allows congress folks like Dick Blumenthal to crow about how they are helping provide needed new antibiotics for Americans without spending government money. GAIN also has a vague clause that states that the FDA has to provide new guidance for antibiotic development. This might actually provide the FDA cover from congress itself as it seeks new, more rapid but also more risky development pathways for antibiotics that target unmet medical needs like activity against superbugs.
In another bit of news last week, the Innovative Medicines Initiative announced a new public private partnership to foster R&D for new antibiotics. They are targeting the development of new clinical trial designs for antibiotics for unmet medical needs and new discovery pathways for antibiotics active against Gram-negative pathogens. This is all well and good and we all welcome this effort. But, as always, the devil is in the details. And in spite of trying to carefully study and understand the details as presented in all the documents on the IMI website, I find I am completely confused. It looks like all the large funding blocks have already been committed to the two largest European PhARMA (EFPIA) contributors, GSK and AZ. So, if another company wanted sufficient funding to support phase III trials, I am not sure it would be there in any case. It also looks like the partnership is designed to partner companies or academics with EFPIA members and that opportunities for R&D outside the EFPIA group is limited. It looks like I am not the only one with questions on this front. Finally, it looks like the research awards will be similar to those done within the context of the European Framework grants – NO! NOT THAT!!! Anything but that!!!