On Monday we posted about an issue that was brought to our attention relative to OGD’s position on goal date assignment, or lack thereof, to an ANDA with unresolved eCTD problems. We provided examples of some of the issues that firms were finding and we found that while there is merit to asking firms to fix their submissions if problems are found in the review, we were stunned that OGD was now taking an action to file the ANDA (because they really are prohibited from refusing-to-receive an ANDA until May 5, 2017, the date on and after which all submissions (ANDAs, DMFs, etc.) must be in electronic format, but not assigning a GDUFA goal date to the ANDA. The reason most people we talked to were upset is that this came out of left field without any warning, notice, or acknowledgement of a policy change.
OGD was obviously surprised that industry was surprised by their actions. In discussions with OGD senior management, I expressed what I felt was the real reason for industry’s concern and that was OGD implemented what appeared to be a new policy to treat ANDAs that had unresolved eCTD issues by deciding that they did not comport with the requirements for eCTD submission and would be treating them like paper or hybrid submissions and not assigning goals dates. Prior to implementation of this policy, OGD would have refused to receive the ANDA, the firm would lose 25% of its user fee, would fix the ANDA when it could, and then resubmit and if the ANDA was received, they would still be assigned a GDUFA goal date. It should be noted that FDA has been up front that a paper submission or hybrid submission would not receive a GDUFA goal date and industry had always been aware of that fact. The question then is what is the definition of an electronic submission?
OGD provided the following rationale to me in our discussions:
- In all instances industry is given time (7 days) to correct the eCTD issues. If they or their contractor cannot meet that timeframe, then we must take some action and that action must be consistent among applicants.
- If there are problems, such as illegible pages, then it is not possible to fully review the ANDA and those items need to be fixed before the ANDA is accepted for review. If they are not fixed in time, then no GDUFA goal date will be assigned.
- The individual made an interesting point that even if an ANDA had come in when I was at OGD (when dinosaurs walked the face of the earth) where some of the pages of the application were in a foreign language, we would have refused it. (While that is correct, we would have refused-to-receive it. However, there is a regulatory provision in the ANDA refuse-to-receive provisions that address this specific issue see 21 CFR 314.101(d)(5)). In addition, we were not collecting over $300 million dollars in fees back in the day.)
- FDA also addressed another interesting point related to the level of quality control that the sponsor employs in review of the ANDA submission prior to sending it to FDA. These are the types of issues that should be caught prior to pushing the send button on the FDA gateway. Sponsors need to do a better job of QC on their submissions. (Hard to argue with that, but sometimes the problems are not evident to the sponsor – my observation was met by OGD saying if the problem is caused by the system, then OGD is willing to speak to the applicant to resolve the issue.)
- What about the fee issue if the 7-day deadline can’t be met? The reply was, well, that is an issue that is out of FDA control and there should be a better relationship between the sponsor and any contractor to assure that a quality electronic submission is developed, or if it happens to be a bioequivalence report, that the CRO should be held responsible for assuring the quality of the report. But ultimately, it is the sponsor’s responsibility to ensure the quality of the submission. FDA noted if the time period for correction cannot be met, the sponsor could always withdraw the submission and resubmit, and will then be able to be assigned a GDUFA goal date, if the ANDA is received.
- As to the issue of the implementation without notice to the industry, FDA noted that perhaps they should have done a better job of disseminating this policy, but we had to do something and the only way we could implement the program was to treat everyone (big and small firms) the same.
While there is some right and what I perceive as some wrong on both sides of the aisle, the fact that OGD could implement a policy that differed so dramatically from how they had handled the same situation since the beginning of GDUFA without any notice to the industry, is yet another example of where a little communication could have gone a long way towards providing the type of transparency the industry is seeking. The next steps are unclear, but certainly there will likely be more dialog between FDA and industry on this issue.