Discussion of high drug prices, shortages and brining pharma manufacturing home has been an ongoing subject and it is discussed in every Congress. Executive orders (too many to cite) have been issued and nothing has changed. Interference besides pharmaceutical companies comes from TORS. Who are TORS? They are Distributors, Regulators, Legislators and Litigators. Each has financial interest and do what they can do to derail any and every progress.
Current administration has issued Executive Orders (1,2,3) and we will have to see if anything happens as there are many vested interests in their way to prevent their implementation. Perspective presented is unbiased and not influenced by an for profit and non-profit organization.
To get to Most-Favored-Nation pricing and bring pharma manufacturing home, the current business model along with how pharmaceuticals are distributed in the United States will have to change. All of these are going to be a challenge. Companies with about 2.5 TRILLION dollar revenue (pharmaceutical benefit managers (distribuTORS), pharmaceutical companies, health insurance etc.) will exert every bit use of political influence on (legislaTORS), litigaTORs and RegulaTORS. Reason is very simple. Too much distribution disruption and relearning pharma’s development and manufacturing capabilities can be avoided by money if status quo can bought. However, if the current US administration forces the issue, things will have to change staring from pharma’s methods (product development, manufacturing) and regulatory approval methods. Distribution will be disrupted. Alternate approval methods will have to considered and implemented (4).
For the last twenty years I have discussed manufacturing technology issues and published solutions in articles, my blog and books. Manufacturing processes of the Active Pharmaceutical Ingredient (API) and their formulations are bench top processes. I call them round bottom flask and mortar and pestle processes. They could be easily fitted in the equipment of the age and have been the main stay of pharma manufacturing.
Most of the chemical synthesis manufacturing processes and methodologies are batch processes fitted in the existing equipment. Reasons and rational are simple. Minimize investment. There are other ways improve manufacturing process that also minimize investment, discussed in the books. cGMP practices have to followed irrespective of the equipment used. Involvement of the VILLAGE from inception of the product can simplify the manufacturing processes i.e. lower cost. I am not going into the reasons and rationale but internal complacency, tradition and regulatory needs have been an impediment in use of better processing methods (5,6,7). Process of continuous improvement does not exist in pharma manufacturing as each modification has to be approved by the regulators, a very expensive process. Result is companies are afraid to make even minor tweaks to the processes.
To bring pharma manufacturing home and companies to profit their practices have to become current. Very creative and imaginative chemical engineers and chemists at the pharmaceutical companies with the cooperation of FDA can BRING PHARMA MANUFACTURING HOME. No such attempt has been made. Billions are being invested in antiquated methods and manufacturing technologies (too many to cite). These will not deliver what is expected by the current US administration.
If any headway has been made at least it is not obvious. I am not sure about recent announcements for new plants that will come on stream in few years should be a consideration of bringing manufacturing home. This is a harsh observation but is a reality. Question is what do they do for US’s short term needs. It seems more of a public relation ploy in front of legislators and press.
In order to bring manufacturing home, pharmaceutical companies have to proactive and be directed by a Pharma Czar (8) who directly reports to the President of the United States. Drug distribution methods and policies will need to be modified. Again undue influence of TORS will have to be warded off.
Fitting processes not only has not only been less productive but also results in high emissions per kilo of the drug. Yes it minimizes investment but there are alternates. They can lower manufacturing costs and they need to be considered (4,5,6,9). Involvement of village would be necessary as after the fact ways that have been practiced have to go by the wayside.
I have presented my perspective in the following and good, experienced chemists, chemical engineers and business folks need to review. They can practice and/or modify to bring manufacturing home and lower drug prices. Following have been presented to bringing pharma manufacturing home and ways to improve profits.
1. Malhotra, Girish: ONE PAGE Road Map to Reduce Drug Shortages, Assure Quality and Improve Affordability December 6, 2019
2. Malhotra, Girish: Health and National Security Issues for the USA and Is The United States of America Prepared May 8 , 2020
3. Malhotra, Girish: A road map for driving pharmaceutical manufacturing back to the USA by 2025 October 8, 2020
4. Malhotra, Girish: US’s Self Sufficiency for Generic Drugs: A Supply Dilemma and Potential Solutions March 31, 2022
5. Malhotra, Girish: Roadmap to Reduce Drug Shortages and Bring Pharma Manufacturing Home (US) October 30, 2023
6. Malhotra, Girish: Remedy of US’s Drug Supply Chain Shortages and Domestic Production of Generic and Brand Drugs April 15, 2025
7. Malhotra, Girish: An Outlier Plan to Bring Pharmaceutical Manufacturing to USA in One Year April 28, 2025
8. Malhotra, Girish: Implementing Executive Orders on Domestic Production of Critical Medicines and Achieve Most Favored Nation Pricing June 11, 2025
9. Malhotra, Girish: An Unconventional Analysis: Can the Wrath of Most Favored Nation Pricing (1) be Avoided by Bringing Pharmaceutical Product & Process Development and Manufacturing Practices to 21st Century? July 8, 2025
To accomplish the objectives of MFN pricing (2) the MOST IMPORTANT AND CRITICAL item is that every manufacturing change and practice has to come INTERNALLY FROM THE PHARMACEUTICAL COMPANIES as they have command of their culture, process chemistries, understand their manufacturing landscape and every other detail. There are very many vested interests (regulators, consultants, contract manufacturing organizations) that will vie to meddle in but no one knows the business better than folks at the companies. Over the years many have stepped in with no results. Focus has to be razor sharp. Task is not going to be easy unless it is tried and tested internally nothing will change. Companies have the knowledge and what it will take to bring manufacturing home. With the resident talent and application of chemical engineering fundamentals, creativity and imagination the factory costs can be reduced, profits improved and profits improved (5, 6, 7, 8). We need to exploit them. Change has to come and is overdue. May the FORCE be with you.
Girish Malhotra, PE
EPCOT International
1. EO 14293 Regulatory Relief To Promote Domestic Production of Critical Medicines Accessed May 5, 2025
2. EO 14297 Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients Accessed May 15, 2025
3. Executive Order 14273 Lowering Drug Prices by Once Again Putting Americans First Accessed June 2, 2025
4. Malhotra, Girish: ONE PAGE Road Map to Reduce Drug Shortages, Assure Quality and Improve Affordability Profitability through Simplicity December 6, 2019
5. Malhotra, Girish: Active Pharmaceutical Ingredient Manufacturing: Nondestructive Creation De Gruyter April 2022
6. Malhotra, Girish: Chemical Process Simplification: Improving Productivity and Sustainability John Wiley & Sons, February 2011
7. Malhotra, Girish: Chapter 4 “Simplified Process Development and Commercialization” in “ Quality by Design-Putting Theory into Practice” co-published by Parenteral Drug Association and DHI Publishing© February 2011
8. Malhotra, Girish: Profitability through Simplicity