In the wake of the recent Ebola pandemic, we realize the importance of pushing drugs and pharmaceuticals through the FDA approval process as quickly as possible. From drug discovery to FDA approval, the average drug takes roughly ten years costing $2.6 billion dollars during the process. Delaying the drug from reaching market just one day can cost the sponsor millions and potentially the lives of patients hindered by the condition the drug is to treat. With the pressing need for cures and treatments, an expedited approval has the potential to be advantageous for all. Over a series of blogs, I will review the four FDA expedited review programs.
The Fast Track approach to FDA expedited review is intended for drugs aimed to treat serious or life-threatening conditions and fill an unmet medical need. According to Section 506(b) of the FD&C Act, a product is eligible to be labeled as a fast track product “…if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.”
Another qualifying criterion is that the drug has been designated as a qualified infectious disease product, or QIDP. A QIDP is defined as an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by an antibacterial or antifungal- resistant pathogen or another qualifying pathogen, as listed by the FDA secretary.
Also for a drug to be considered for Fast Track eligibility, it must be advantageous to current available treatments. This is determined by: showing superior effectiveness, avoiding serious side effects of available treatments, improving the diagnosis of the disease, and decreasing a clinically significant toxicity of an available treatment.
Title VIII of the FDA Safety and Innovation Act (FDASIA) provides incentives for the development of a pharmaceutical that treats a serious or life threatening infection. This blog describes the Generating Antibiotics Incentives Now (GAIN) provision of FDASIA, which is an attempt to develop drugs in response to growing rates of microbial resistance to antibiotics. It is under the FDA’s discretion on what pathogens/diseases are qualified for this program.
Pharmaceutical companies are to request a fast track expedited review for their product, ideally before the pre-Biological License Application (BLA) or New Drug Application (NDA). Upon receipt of the request, the FDA has 60 calendar days to issue a response. Once a drug is designated as a Fast Track drug, communication between the sponsor and FDA is encouraged to be more frequent, so that questions and issues may be resolved more quickly, potentially leading to earlier approval.
There are other differences between a Fast Track drug and regular drug approval processes. A sponsor may meet with the FDA more regularly to discuss the drug development plan and ensure the collection of applicable data. The sponsor is also encouraged to have more frequent written communication with the FDA regarding clinical trial design. Eligible drugs may enter “rolling review”, allowing completed sections of the BLA or NDA to be submitted rather than waiting for the entire application to be completed before submitting. The primary purpose for these revised processes is getting the drug approved as soon as possible. There are more details on this process, as noted in the Expedited Programs Guidance document, which was published in May 2014.
When a serious disease or condition effects a large population, speeding up the drug approval process, even by just a few days, may significantly improve the quality of life for many patients while saving pharmaceutical companies time and resources. What are your thoughts on this expedited process?
Stay tuned for upcoming blogs on the other expedited review processes!heat-1a.7252.race via photopin (license)