On October 1, 2018, the FDA opened a portal (here) that permits firms to submit Controlled Correspondence (CCs) directly and electronically to the FDA. The process is further explained here, including how to register for use of the portal. This could help speed CCs to the Agency, but it is the problem with what happens to some once they reach the Agency that has raised some industry eyebrows, including mine.
I call it CC hell. In reality, it is more frustrating, at least for me, than anything since the failure to include an old DESI notice in an ANDA filing for a pre-62 drug product, which could result in a refuse-to-receive action, and that goes back to 1984-1986.
Having experience problems with CCs, I thought that maybe it was just me. But, in speaking with other industry representatives, there are a few common themes that keep popping up. But let me step back for a minute. According to the FDA, the GDUFA-stated goal for controlled correspondence is 90% responded to within sixty days. The trick is you must have the CC accepted before the clock starts. Not always easy. Format and neatness count is what my seventh-grade English teacher used to say, and God forbid your format is the least bit off. If it is you, you’ll get a very nice correspondence from FDA telling you that you failed the test and to revise your correspondence to the correct format. This causes a delay (and most times that is on the submitter), but come on, if the body of the request is clear, why can’t the FDA just answer the bloody question?
So, after that delay, you revise the format and resubmit the request. In one instance, we got rejected again because the CC reviewer could not find an RLD designation in the Orange Book (OB) for the product cited as the RLD in the CC even though it was an older NDA that was previously designated as an RLD. The FDA had failed to include the RLD designation for that product when it first updated the OB to include all RLD designations. Another delay because the FDA screener either did not recognize it as a previously approved NDA or they just did not go back to look. After a phone call to the FDA, the designation was fixed but that caused another thirty-day delay until the next OB cumulative supplement was published. OK, now we submit again.
The CC screener then said the CC was asking for guidance on the bioequivalence requirements for a specific product and that they would submit our request (which they could have done when it was first submitted) to the appropriate office for review and issuance of a BE guidance. Now we’re sixty days into the process; however, upon closer examination (which the CC never got) our request actually asked for more of a confirmation of a regulatory issue than asking for BE guidance. Because that was not recognized, now we sit waiting for who knows how long for a question to be answered that could have been confirmed in two minutes if whoever initially reviewed the CC really understood what was in it.
I am glad I am hearing the same things from other industry colleagues. This is like several rounds of CC submission to get a relatively easy answer to a simple clarification question. It’s like asking a question about an issue in an FDA guidance document that is unclear and getting a response referring you back to the passage in the guidance document that you indicated you did not understand. It’s like failure of the reviewer to understand the regulatory history of the Hatch-Waxman Act and getting your CC kicked back without an adequate response. And the worst is getting back a response that does not answer the question you asked.
I wonder whether all these kick-backed CCs are included in the number of CCs reported in the Generic Drug Program Monthly Progress Report. Could this explain why the number of CCs reported seems to keep going up?
