All opinions are my own.

Friday, May 8, 2020

Health and National Security Issues for the USA and Is The United States of America Prepared

Lack of vaccine and proven treatment for COVID-19 has had the world scrambling to find treatments. Every pharma company is looking for ways to control the disease. Hydroxychloroquine and other drugs have been suggested and used. They might work on individuals but its efficacy is anecdotal. US had difficulty in acquiring sufficient dosages from overseas. FDA had to let that company it had banned to export to US ship to US. US and Indian governments at its highest levels had get involved. This brings up a point of discussion of having capabilities to acquire or produce critical drugs. There is no financial interest with any entity.

Answer to this question for the developed countries is flat NO. 

Most of the generic drugs which are better than 80% of the total US prescription market are imported from China and India (1). If the drugs stop coming from these countries, US will have no capability to serve its populations pharma needs (2)

I am sure US legislators are cognizant of these facts and considering alternate options. Ultimate remedy has to bring pharma manufacturing home. However, there are three bottlenecks. They are:

  1. US FDA
  2. Pharma lobbies
  3. Pharmacy Benefit Managers (PBM)
There is no point in discussing what these have done as everyone is aware of there doings. They can implement plans to remedy the situation and bring pharma manufacturing home. 

Pharma and PBM lobbies have to be contained. In addition US FDA has to fix its broken ANDA approval system and create an environment and incentive to bring manufacturing home. Some of these plans are laid out in eth linked blogs. 

1.     What Is Needed for a Regulatory Approval of NDA/ANDA Filings in 90 Days? http://bit.ly/31ALUcu

2.     Impact of Regulations, Manufacturing and Pharmaceutical Supply Chain (PBMs) on Drug Shortages and Affordability Part 2 https://bit.ly/2TYQeOQ

3.     Drug Shortages, Quality and Prices: Who is Responsible? http://bit.ly/2oVgmAD

4.     ONE PAGE Road Map to Reduce Drug Shortages, Assure Quality and Improve Affordability http://bit.ly/34RYypH  

5.     Strategies to Increase Generic Drug Competition and Bring Manufacturing to The United States of America http://bit.ly/3d0gjaO

6.     How Would US FDA Behave/React if They Were on the Receiving End? https://bit.ly/3bwGiVW

7.     Long Term Drug Quality Supplies for US, FDA and A New Reality https://bit.ly/3aKaxZw

Above are ideas that can be used to fine-tuned to create and implement viable plans.  

Girish Malhotra, PE
EPCOT International

  1. https://www.statista.com/statistics/205042/proportion-of-brand-to-generic-prescriptions-dispensed/ Accessed May 8, 2020
  2. Gibson, Rosemary, China Rx: Exposing the Risks of America’s Dependence on China for Medicine, https://www.uscc.gov/sites/default/files/RosemaryGibsonTestimonyUSCCJuly152019.pdf, accessed May 8, 2020

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