This blog post recaps some of the ideas that have been proposed in the recent past and also presents some additional ideas to bring pharmaceutical manufacturing to USA. Task at hand is a challenge as many vested and personal interests that can be a major hurdle to produce active pharmaceutical ingredients (API) and their formulations in the United States of America (1). Perspective presented in my own and devoid of any financial relationship with any profit or non-profit making entity.
Recap:
Every profit making company will manufacture their products in the country where they can maximize their profits. In the last twenty five years US API producers and their formulators could not compete with imports from overseas as the US based manufacturing companies could not give the pharmacy benefit managers and insurance companies the levels of profits overseas companies could give. In addition, companies instead of innovating manufacturing technologies to deal with challenges posed by the environmental laws to preserve the eco systems opted to partner with companies that had to deal with less stringent environmental laws. These could have allowed them to capture the ever growing global markets (2). Consumers (patients) in the developed countries became dependent and addicted to the lower generic drug prices passed on by the companies that came from not proving bioequivalence and much less stringent environmental compliance laws.
New considerations to bring generic pharmaceutical manufacturing:
Ators mentioned in earlier post (1) also need to consider the following if manufacture of pharma has to be brought to the United States.
1) Financial Incentives: Any company establishing a pharmaceutical manufacturing plant in the US should be given a TEN year tax benefit. This would be a great incentive to have a pharmaceutical (API and formulation) plant in US. Companies would lie to get this advantage.
2) Level the playing field: Environmental Laws: Any imports of generics to US have to comply with US environmental laws at producer’s manufacturing sites (3, 4, 5).
3) Eliminate the Formulary lists: If a drug is approved by FDA, it means it is a useful drug for the disease, rather than being selected by PBMs (Pharmacy Benefit Manager) who are in the name of getting the best price benefiting from buying and selling.
4) Direct Marketing to Patients: Let the pharma manufacturing companies do direct selling to patients through approved channels (6, 7). This will bring in competition and quality, a normal expectation, through use of best technologies which has eluded pharmaceutical manufacturing.
Recent Blog Posts:
1) Product Quality: Any company and that includes every PBM or their agent or direct/indirect importer of generic drugs in the supply chain product quality non-conformance has to held accountable through ban of sale of such products in the US. If the product does not meet the established quality as approved by US FDA and agreed by the ANDA filing company its approval should be withdrawn (1, 8, 9). No 483 should be issued.
2) ANDA Approvals: Any company wanting to produce generics in US should have their ANDA review and approval done in THIRTY DAYS (1, 9). This will be a task as US FDA will have to change its modus operandi. If FDA cannot accomplish this approval timetable and stay with the current model, there is no incentive to invest in manufacturing USA.
It should be our expectation that our legislators and regulators (ators), who claim to be really serious about continued supply of drugs and healthcare (PPE, personal protective equipment included), will find pathways to accomplish and serve the strategic needs of the United States of America unless they are influenced by vested interests. Pharmaceutical companies will have to be proactive and compete for the market and profits. PBMs will be an interference as their profit landscape could change if direct prescription sales come to fruition. Regulators could find their influence curtailed.
Creativity and imagination would be needed if US wants to bring pharmaceutical manufacturing home e.g. in the next 365 days.
Girish Malhotra, PE
EPCOT International
1) Malhotra, Girish: Euphoria to Bring Pharma Manufacturing Home to United States its Reality and Challenges, Profitability through Simplicity, May 23, 2020
2) Malhotra, Girish: An Alternate Look at the Pharmaceutical World Revenues and Drug Affordability, Pages 2-5, CPhI Annual Industry Report, 2017
3) Malhotra, Girish: Can Uniform Safety, Health and Effluent and Manufacturing Standards Create Process Technology Innovation and Competition in Pharmaceuticals? Profitability through Simplicity, January 10, 2017
4) Malhotra, Girish: Why Have the Fine and Specialty Chemical Sectors Been Moving from the Developed Countries? Profitability through Simplicity, February 9, 2009
5) Malhotra, Girish: Pharmaceuticals, Their Manufacturing Methods, Ecotoxicology, and Human Life Relationship, Pharmaceutical Processing, November 2007
6) Malhotra, Girish: Improving Drug Affordability for the United States Populous through Alternate Business Models, Profitability through Simplicity, May 4, 2018
7) Malhotra, Girish: Could Amazon (A), Berkshire Hathaway (B) and J.P. Morgan Chase (M) be the Anti-Ballistic Missile (ABM) needed to Control/Curb Rising Healthcare Costs? Profitability through Simplicity, February 9, 2018
8) Malhotra, Girish: ONE PAGE Road Map to Reduce Drug Shortages, Assure Quality and Improve Affordability, Profitability through Simplicity, December 6, 2019
9) Malhotra, Girish: Strategies to Increase Generic Drug Competition and Bring Manufacturing to The United States of America, Profitability through Simplicity, March 16, 2020
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