All opinions are my own.

Monday, November 2, 2020

Comment posted for Public Health Focused Essential Meds, MCM and Their Critical Inputs List to Address Section 3(c) of EO 13944(1)

FDA posted List of Essential Medicines, Medical Countermeasures, and Critical Inputs as they are required by the executive order. 

By providing a list, it is good to see FDA has done some constructive work to alleviate essential drugs. My rating on a scale of ONE to TEN is about TWO. WHY? My explanation is as follows. 


Significant work is and would be needed to produce the identified drugs. Following questions need to be addressed. I am not sure if FDA has any capability or the expertise to address any of the questions. 


That being said without a timetable set by the US Government, we should not expect much or be ready for a long time unless someone has better ideas. 


We should not be surprised if any of the needed APIs are NOT manufactured in the United States. If they were, we would not have shortages. Based on how much API is needed to produce large dosages, one should not be surprised that any company opting to produce these drugs would be challenged. 


There are many hurdles/obstructions to the list. The task is not going to be easy. All of the following questions need to addressed. Significant concerted effort https://bit.ly/3nxOlIz (2) is needed.   


Following information would be needed. 


1.     What are the quantities needed for each API? 

2.     Has anyone at FDA spent time to figure out where the needed raw materials for API will come from? Most likely the needed raw material are not manufactured in the United States.  

3.     If there are plants in US do they have the necessary and adequate equipment and trained personnel to produce any of these APIs? 

4.     Since these APIs are not produced at any of the US based plants what kind of ANDA approval time would be needed from FDA. Is it going to be its routine 36-48 months? Is so, the basic need to have these drugs readily available would be defeated. Unless FDA alters its current practice from 36-48 months to 90 day approval http://bit.ly/33SiqHS (3) not much will change. It is possible to make the change but effort would be needed and that includes mindset at FDA. 

5.     Do the companies who opt to produce these APIs in the United States have the processes that are economic to meet the price constraints PBMs put on the suppliers? One has to remember that unless PBMs make their required or necessary margins they will not distribute these drugs in the United States. Would the API producers be able to make their margins in light of PBM constraints? 

6.     In FDA’s proposal it keeps on touting that “Advanced Manufacturing” will or can alleviate COULD reduce shortages. Irony is that FDA has never tested whatever they call “advanced” on a commercial scale for any product. FDA does not have the manpower that is experienced to test any of what they call “Advanced Manufacturing”.  Their feasibility and economics have never been put to test. There is HUGE difference between what works in the laboratory and what works on a commercial environment. 


Based on the bureaucracy of FDA which it wants to protect at every cost, just publishing this list is nice effort but unless there is government edict or API producing companies have huge financial incentive not much will happen with respect to drug shortages of essential drugs. 


Girish Malhotra, PE

EPCOT International


1.     https://www.federalregister.gov/documents/2020/08/14/2020-18012/combating-public-health-emergencies-and-strengthening-national-security-by-ensuring-essential

2.     Malhotra, Girish: A road map for driving pharmaceutical manufacturing back to the USA by 2025, Profitability through Simplicity October 6, 2020 Accessed November 2, 2020 

3.     Malhotra, Girish: Can the Review and Approval Process for ANDA at USFDA be Reduced from Ten Months to Three Months? Profitability through Simplicity, March 25, 2017 Accessed November 2, 2020