With the approval of only 20 ANDAs in May (information derived from the CDER application approvals report), a statistic that is sure to give CEOs heartburn, the industry may start to question the GDUFA goals, unless many more ANDAs are driven to approval. As I have written before, Complete Response Letters (CRL) are the measure of GDUFA success based on the GDUFA metrics, but you can’t market products that receive Complete Response Letters. If I am not mistaken, the 20 monthly approvals are perhaps the lowest since the generic drug scandal back in the late 1980s and early 1990s.
As we used to say when I was at the FDA, the concept of “moving the freight” really motivated OGD staff to getting approvals out the door. Under the GDUFA metrics as outlined in the Goals Letter (here), success is measured by issuance of CRLs and not by approvals. Much has been said about the Goals Letter and it represents the mantra that the industry must live by until GDUFA 2 is negotiated and revised prior to October 1, 2017 to extend the program (and I don’t see any way the industry could make do without the program unless Congress came up with $300 million of additional appropriated funding for the generic program, which is not likely). It is understood that the Office of Generic Drugs (OGD) is not turning a blind eye to the issue of approvals and they recognize that, until an application is approved, it will cycle back through the review process again and again.
With OGD racing to provide Guidance documents that industry is hungry for, with their involvement in training a significant number of new staff, and also developing policy under the GDUFA program, many of the resources that were previously devoted to nothing but application review have been diverted to accomplish these necessary tasks. But how long will Industry give OGD to turn the corner? What type of progress will need to be demonstrated before industry begins to see the light at the end of the tunnel? Good questions, and let’s hope the light is not that of another train coming down the tracks!
Will industry continue to judge success of GDUFA by CRLs or will their bottom line necessitate exerting political pressure if the number of approvals does not increase? Is there a disconnect between the plain reading of the Goals Letter and the industry, even though the industry was at the negotiating table? Only time will tell, as the GDUFA metrics begin for new applications submitted on or after October 1, 2014, which is only 110 days from today.
