US FDA posted a press release “FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing” (1) outlining its NEW PROGRAM to strengthen its processes. It proposes a PreCheck in response to EO14293 (2).
FDA (1) has suggested TWO steps and they are:
1. First, the Facility Readiness Phase provides manufacturers with more frequent FDA communication at critical development stages, including facility design, construction, and pre-production. This phase also encourages companies to provide a comprehensive facility-specific information through a Type V Drug Master File (DMF), such as site operations layout and description, Pharmaceutical Quality System elements, and Quality Management Maturity practices. This facility-specific DMF can be incorporated by reference into a drug application as appropriate.
2. Second, the Application Submission Phase centers on streamlining development of the Chemistry, Manufacturing, and Controls section of the application through pre-application meetings and early feedback.
I am presenting my understanding of FDA’s PreCheck Program processes. I have no financial relationship with any for profit and/or nonprofit organization.
FDA personnel, my conjecture, will never have complete understanding and/or command of each product and process as that is the jurisdiction of the company producing the products. Companies know their manufacturing processes better than anyone else. If they do not then every chemical and pharmaceutical company has a major problem. FDA through this (1) is suggesting they know more about company’s processes, products and manufacturing. As a regulatory body FDA or for that matter EPA also has to rely on what the company is presenting and saying will do to produce quality product/s. Is FDA suggesting that companies do not understand their product, process and manufacturing processes? With that being the case how FDA personnel, that has minimal and/or no experience in process development, manufacturing and commercialization will be able to advise a company of “facility phase readiness”. FDA just put a CART BEFORE THE HORSE and exposed itself for telling the world that best of the chemical/pharmaceutical companies don’t know much about what they commercialize.
It is my understanding that currently FDA and companies meet to address any questions through in-person meetings. In PreCheck what will be different from the current situation. I would be tempted to call this a case of “sanctioned delays”.
Meeting product’s established quality specification, performance and following cGMP guidelines is company’s responsibility and should be demanded by FDA from every company to produce their products. FDA and or any other regulatory body should have the authority to stop production (3) if they do not deliver expected product quality. FDA should very clearly define the information that each company needs to submit for approval. What FDA has issued is complex and needs simplification. My best postulation is even FDA personnel cannot fill an application. USA needs to adopt and consider processes where NDA(new drug application)/ANDA (abbreviated new drug application) (3,4,5) can be approved in 90 days. They have been discussed since 2017 and for EO 14293 to be a success their adoption and implementation is critical (3,4,5).
I posted my first reaction about FDA’s PreCheck on LinkedIn (6) when I saw the news release (1). I consider this as an official sanction for the delays. EO 14293 (2) will never come true as there is no timetable to be met. Without any timetable for domestic production for critical drugs, FDA’s processes (1) are of no value to US population.
We have to recognize that it is company’s responsibility to produce quality drugs and FDA’s responsibility to expedite the approval process. Fact that the Presidents of The United States have issued Executive Orders (2,7,8,9) for the expeditious manufacture of critical drugs and it seems no one has taken responsibility for their implementation. It seems they (7,8,9) have been ignored and gone by the wayside. How FDA’s PreCheck, a new name for existing practice will promote domestic production?
FDA’s processes need revamp. If not done the issue of critical drugs and shortages will keep rearing its UGLY head every so often. There are many vested interests that will interfere (10) in the process and need to stay out the way.
Girish Malhotra, PE
EPCOT International
References:
1. FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing August 7, 2025
2. EO14293 Regulatory Relief To Promote Domestic Production of Critical Medicines, May 5, 2025
3. Malhotra, Girish: ONE PAGE Road Map to Reduce Drug Shortages, Assure Quality and Improve Affordability Profitability through Simplicity, December 6, 2019
4. Malhotra, Girish: What Is Needed for a Regulatory Approval of NDA/ANDA Filings in 90 Days? Profitability through Simplicity, October 24, 2018
5. Malhotra, Girish: Simplified Roadmap for ANDA/NDA Submission and Approval will change Pharma Landscape, Profitability through Simplicity, November 25, 2018
6. LinkedIn August 7, 2025
7. Executive Order 13588 Reducing Prescription Drug Shortages, October 31, 2011
8. Executive Order 13944 Ensuring critical medicines are made in US August 14, 2020
9. Executive Order 14017 America’s Supply Chains Feb. 24, 2021
10. Malhotra, Girish: Most Favored Nation Pricing & Bringing Pharmaceutical Manufacturing Home, Profitability through Simplicity, July 13, 2025
