On October 3, 2025 CDER FDA (1) announced “New ANDA (abbreviated new drug application) Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing” (2) process it would like to experiment with in its efforts to bring generic manufacturing home to USA.
FDA has ignored the need for US manufacturing and not done nothing even after numerous testimonies in front of US Congress by various responsible FDA personnel and US Presidential Executive orders (3). The recent proposal/experiment (1) to bring generic drug manufacturing home is due to considerable pressure from the current US Administration.
Following is part of FDA’s acknowledgement (1) and proposal to bring generic drugs manufacturing home.
Overreliance on foreign drug manufacturing and testing creates risks both to national security and patient access, and undermines investments in U.S. research, manufacturing and production,” said Dr. George Tidmarsh, M.D., Ph.D., Director of FDA’s Center for Drug Evaluation and Research. “It also slows down reviews and costs taxpayers more money, as these foreign research and testing sites must be inspected by FDA, and foreign inspections take more time to prepare for and are more expensive to conduct than domestic inspections (2).
The proposed process is flawed, in my estimation, as it has not been thought through and has significant limitations. Perspective presented is my own and not influenced for any outside influencers.
Several proposals to bring generic drug manufacturing home have been proposed (3,4,5,6,7) and all have been shared with CDER (1).
In the current proposal (2) it seems that that every ‘t” has been not crossed and every “i” has not been dotted. It relies on an old FDA proposal (8). Was this ever tested? If it was successful why it was not implemented.
Under the current proposal (1) for the companies to apply for FDA’s consideration they have to meet the following requirements.
1. ANDA applicants have to have conduct the required bioequivalence testing in the United States.
Does FDA have a list of companies that are in the public domain and is their testing acceptable to US FDA? Is the list in public domain? Would FDA accept bioequivalence test results from the US based companies and have they been approved? What is their track record?
2. One of the requirements for the priority review (2) is that “company’s products are made in the U.S. using exclusively domestic sources for APIs.” This would mean raw materials and equipment.
Have the authors and proposers of the guidelines (2) checked the availability of raw materials in USA? Does FDA know and understand that majority of the raw materials are not available in USA? Has FDA thought through the raw material availability limitation? This will result in very few, if any, companies to qualify for “priority review submission”. There are and/or gaping deficiencies in the proposed path (2). Even ONE success should not be considered a total success. US has long ways to go before it can call bringing generic drug manufacturing home.
With that being the case how many companies will qualify and would be able to fulfill the basic requirements of the new proposal (2). Based on nonavailability of US raw materials FDA’s ANDA Prioritization Pilot (2) is destined to failure and possibilities of its success are close to zero on a scale of one to ten. Is this proposal just a window dressing to show the current administration, US Congress and public at large that it is doing something to bring generic drug manufacturing home.
3. The new Pilot ANDA (1) is based on a program that was proposed by FDA (8) in 2006. Was that program ever tested (8)and/or adopted by FDA and or any pharmaceutical company? What are the results? I do not know its success or it has been sitting on the shelves and gathering dust. HAs it been brushed and/or tested/ updated for its validity and applicability to meet 2025 economic and political needs. Are there any case successes?
It seems the current proposal is being suggested under duress and the new proposal (2) is just a trial balloon destined for failure?
US FDA needs to address the doubts cast above and will be cast by many. Another question FDA needs to address is “does it have sufficiently experienced personnel who have prepared the latest proposal and have walked such a talk”. Answers to the above questions will be very interesting. I am sure there are additional questions from others.
Girish Malhotra, PE
EPCOT International
References:
1. CDER
2. New ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing FDA.gov October 3, 2025
3. Malhotra, Girish: Profitability through Simplicity
4. Malhotra, Girish: ANDA (Abbreviated New Drug Application) / NDA (New Drug Applications) Filing Simplification: Road Maps are a Must. Profitability through Simplicity, May 11, 2017
5. Malhotra, Girish: Simplified Roadmap for ANDA/NDA Submission and Approval will change Pharma Landscape, Profitability through Simplicity, November 25, 2018
6. Malhotra, Girish: ONE PAGE Road Map to Reduce Drug Shortages, Assure Quality and Improve Affordability, Profitability through Simplicity, December 6, 2019
7. Malhotra, Girish: What Is Needed for a Regulatory Approval of NDA/ANDA Filings in 90 Days? Profitability through Simplicity October 24, 2025
8. Prioritization MAPP CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 5240.3 Rev. 6
