All opinions are my own.

Friday, April 3, 2020

Long Term Drug Quality Supplies for US, FDA and A New Reality

In the United States, we have come to rely on FDA to make sure that the drugs that are dispensed through pharmacies and mail order are quality drugs. However, COVID-19 has changed the immediate landscape for a while or may be forever. 

A new reality has to be accepted. We need to learn from it and plan for the long term. If we don’t, my apprehension is consequences could be grave. There in financial affiliation with any for/non profit organization. 

Since 1962 US FDA has made regulatory improvements/enhancements in assuring drug quality consistency to the US population. Generic drugs have become part of our lives. Countries have accepted US FDA standards as the gold standard. With time generic drug manufacturing has moved off-shore. FDA has made plant inspections (1) part of routine NDA/ANDA approval process. Deviations from cGMP, record keeping and sanitation etc. result in 483 citation/s (2). However, repeats do not seem to be stern enough reprimands. They might have made companies bold, my conjecture, by taking liberties with their practices. Closure of total sites has been rare and a last resort. 

In the last SIX weeks, Charles Darwin’s “Theory of Evolution”, which occurred over millions of years has been replaced by “Reality of COVID-19 Revolution”. Globally things have changed and we are adjusting to the new reality. If we do not embrace and work with the new reality to address needs of tomorrow , people will die and we could have consequences that will be far different from what has happened to date.  

My conjecture is FDA should change certain aspects of its NDA/ANDA approval processes if it wants US population to have continued supply of quality drugs. There is an opportunity (3). If we don’t hold manufacturing companies are not held accountable (4), we could have prolonged ill effects due to less than quality drugs and non-availability. Their impact could be far greater than the current crisis. 

My recommendation for the US FDA is to consider an alternate proposal that was been suggested earlier (3, 4). I am sure there are other viable proposals. My proposal can be implemented just by stork of pen and I don’t think companies, legislators or lobbyists are going to raise raucous about it as it will save lives in the short and long term. Stipulation would be that instead of having to inspect generic drug producing plants, US FDA will accept CEO/MD signature as guarantee and confirmation that the product/s being produced will meet FDA’s quality requirements and company will comply with what has been submitted in its NDA/ANDA approval application. Signature also means that if company’s product through surveillance testing do not comply with what the company says it will produce, US FDA can simply tell the company that they cannot ship their products to the United States of America for the next FOUR years. 

Consequence of above will be multifold. Companies will be spared the wrath, agony and expense of FDA inspections. They will be proactive to assure quality and use to best technologies which will force competition. FDA personnel will not have to bear the wrath of travel to remote places. They will devote more time to approve NDA/ANDA applications and will be able to create templates to simplify NDA/ANDA approval processes (3)

It is understandable that with the current COVID-19 crisis, attention is focused on the immediate problem. It needs to be. However, we need to think and address how US will address continued supply of quality drugs (4) for now and future. The current crisis should be a­ lesson. If we don’t US could be holding an empty bag later part of this year or come the next crisis. 

Girish Malhotra, PE
EPCOT International 

1.     Inspection citations. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-citation, Accessed April 3, 2020

2.     Malhotra, Girish: Are US FDA 483 Citations a "Medal of Honor" or “Rite of Passage” to Disgrace for the Pharma companies? Profitability through Simplicity, October 16, 2019

3.     Malhotra, Girish: Strategies to Increase Generic Drug Competition and Bring Manufacturing to The United States of America, Profitability through Simplicity, March 16, 2020

4.     Malhotra, Girish: ONE PAGE Road Map to Reduce Drug Shortages, Assure Quality and Improve Affordability, Profitability through Simplicity, December 6, 2010