Elton John is among countless patients worldwide who are counting on antibiotics to treat illness. His doctors hope a combination of antibiotics and surgery will correct an inflamed appendix that forced the musician to cancel his summer concert dates earlier this month.
Complicating matters for those on antibiotics is the growing resistance of bugs to the drugs, and the resulting scarcity of new and effective antimicrobial treatments. A year ago this month, Washington sought to start addressing the problem by folding into the wide-ranging FDA Safety and Innovation Act (FDASIA) law incentives designed to stoke commercial development of new antibiotics against superbugs and other viruses, and known by its earlier name of the Generating Antibiotic Incentives Now (GAIN) Act.
Most notably, the law created the “qualified infectious disease product” (QIDP) designation for antibiotic drug candidates, which entitles their developers to faster FDA reviews and five additional years of market exclusivity.
“As of July 11, 2013, FDA has granted 19 requests, for 12 molecular entities, for qualified infectious disease product (QIDP) designation under GAIN,” agency spokeswoman Lisa Kubaska, Pharm.D., told GEN.
Turns out the GAIN anticipated by FDASIA is a small piece in a tapestry of new rules, incentives, and initiatives that officials, researchers, and physicians now say is needed to stimulate the number and types of new antibiotics needed against antimicrobial resistance.
The latest federal effort on antibiotics took place earlier this month, when FDA issued draft guidance intended to articulate its thinking on streamlining antibiotic development programs and clinical trial designs, even for non-QIDP drugs. Drugs that would be considered for streamlined development, according to FDA, include antibacterials for “serious” bacterial infections in patients with unmet medical need—including pathogen-focused antibacterials, even if they treat a single genus and species of bacteria. Conditions deemed “serious” are those associated with morbidity that has substantial impact on day-to-day function.
Because such patients have few or no other options, the agency wrote, “they are likely to be drugs that: 1) act via new mechanisms of action; 2) have an added inhibitor that neutralizes a mechanism of resistance; or 3) have an alteration in the structure of the molecule that makes the drug no longer susceptible to the mechanism of resistance to existing drugs.”
Antibacterial drugs for patients with intolerance or allergy to current drugs are deemed to address unmet medical needs—as opposed to drugs with slightly greater potency, for which FDA recommends traditional development programs.