Posted 03 March 2017
By Michael Mezher
Despite some improvements, drugmakers say the US Food and Drug Administration (FDA) has not fully clarified its expectations for developing new antibiotic drugs or detailed how to access new incentives, according to a new report by the Government Accountability Office (GAO).
Specifically, GAO says that FDA has issued 14 updated or new guidances focused on antibiotics since the Generating Antibiotic Incentives Now (GAIN) Act was passed as part of the Food and Drug Administration Safety and Innovation Act of 2012, but roughly half of those guidances remain in draft form.
GAO also says that FDA has yet to provide guidance to sponsors on how to navigate the GAIN Act's main incentives.
Under the GAIN Act, drugs that receive qualified infectious disease product (QIPD) designation are eligible for several incentives, including fast track designation, priority review designation and an additional five years of market exclusivity if approved.
According to GAO, half of the ten drugmakers interviewed for the report said they wanted to see written guidance from FDA on how to obtain fast track designation for a QIDP designated drug.
"The lack of clarity on the role of draft guidance for and the lack of written guidance on the QIDP designation create uncertainty for drug sponsors about how much reliance they should place on these draft documents and could diminish the likelihood that drug sponsors apply for the designation because they do not fully understand its requirements and benefits," GAO writes.
Despite the lack of clarity, GAO says that FDA has approved more than 100 requests for QIDP between 2012 and 2015, approximately 90% of the total requests made, and has so far approved six of those drugs.
And, while FDA has granted fast track designation to every QIDP designated product that has requested it, not all sponsors have requested fast track designation despite being eligible.
According to GAO, 40% of QIDP designated drugs have not gone on to receive fast track designation, though GAO notes that some of the drugs may earn fast track designation in the future, or may have already had fast track designation prior to the creation of the QIDP designation. Of the six QIDP designated drugs approved so far, two did not receive fast track designation, as their sponsors, Merck and the Medicines Company, did not request it.
However, drugmakers have also acknowledged other improvements from FDA since the GAIN Act's passage.
According to the report, all ten drugmakers said the GAIN Act "has facilitated FDA's review of their drug applications," and eight said they experienced "increased communication" with FDA following the implementation of the GAIN Act, though, GAO cautions that it is still too soon to tell whether the act has actually spurred the development of new antibiotics as intended.
"The GAIN provisions were passed five years ago, but it generally takes ten to 15 years to develop a new drug and obtain approval from FDA. Therefore, GAIN has not been in place long enough yet to have been a factor in motivating any drug sponsors to develop and submit an application to FDA to market a new antibiotic," GAO writes.