We all can see from the OGD metrics that ANDA submissions and approvals have leveled off and have even gone down recently. In the negotiation meetings between FDA and industry for GDUFA III, it seems the Agency recognizes this, but there are some things that don’t seem to make sense and one item that is actually laughable.
There are significant increases in the number of post approval change requests in the form of prior approval supplements (PAS) and changes being effected (CBE) supplements being submitted to OGD. In addition, the number of controlled correspondences submitted to OGD are also increasing. Well, in business when one area has a decrease in workload and another has an increase, we usually shift resources to accommodate the changing workload and allocate existing resources accordingly. In the case of the minutes of the GDUFA III negotiations, it appears that FDA is saying, well, we may need more resources that deal with the increased supplements and controlled correspondence submissions without addressing the decrease in ANDA original submissions. There needs to be some fiscal accountability and not a blank check for the Agency. User fees negatively impact a competitive market and have an ever-increasing effect on prescription drug prices. In the current environment and pressure on prescription drug costs, this issue needs to be considered in the fee structure because it is the consumer who ultimately pays the price.
These negotiations are mostly confidential but there are hints of these issues in the scant minutes of the meetings (here). When I read the minutes of the December 17, 2020 meeting, one item almost caused me to run for the antacid bottle. Here is the sentence that caused my stomach acid to reach critical heartburn levels:
“Finally, FDA began an initial discussion of a possible proposal to resource more timely consideration of suitability petitions.”
This, my friends and readers, may be the Agency’s understatement of, perhaps, the last decade. “More timely consideration”, come on now, how about “any consideration”. Now, I might seem a bit bitter about this because I was the first secretary of the ANDA suitability petition committee after the passage of Hatch-Waxman and we used to meet the 90-day statutory ANDA suitability petition response time about 99% of the time. Over the last 5-10 years, the Agency seems almost to be totally ignoring ANDA suitability petitions. I have written on this numerous times going back to 2016 (here, here, here, here, here, here, and here). But to say “more timely consideration” while FDA has not updated the ANDA suitability petition list since 2015, and where most and close to all ANDA suitability petitions go unanswered for years, is really a slap in the face to industry.
In one of the posts a few years ago, I suggested fees to cover hiring staff to deal with suitability petitions. Most firms have abandoned submitting suitability petitions and have opted for submission of 505(b)(2) applications for change that are permitted otherwise through a suitability petition. The (b)(2) route is much more expensive and with yearly recurring program fees of over $300,000 for each strength of a product up to 5 in an application, the economics of the (b)(2) is, in most instances, not sustainable for some of these smaller products. I will close this rant with a simple request, please call the ANDA suitability petition process what it has been, a major failure of the last 10 years and get with the program to get this statutorily mandated process back on track.
