Stop Asking the FDA for Covid Vaccine Supply
(Thursday, February 4, 2021)
Apparently, FDA has been getting calls from consumers asking about where to get the Covid vaccines leading it to release the public announcement that it does not control distribution of vaccines, only their approval. It is obvious to the regulated industry, but the public has a different perception of the FDA, in that FDA is seen as an all-powerful government agency that controls all drugs in the country. Part of it is due to the perception created by the manufacturers who suggest to their customers that FDA is delaying or holding approval of their products due to bureaucratic reasons or that FDA does not allow them to provide assistance to the consumers by making unfriendly rules. Partly FDA has been the political scapegoat for delays in approval decisions. And this is not an isolated incidence and it is not limited to Covid vaccines. The media and industry groups frequently misrepresent the role of the FDA to their consumers, particularly when comparing FDA to other regulators. FDA prides itself as the most diligent regulatory agency in the world. It is an agency whose goal is impassionate review of scientific data, which ends up saying NO more than YES since good data takes time and effort to create and review. No other regulatory agency in the world conducts a more thorough independent data review for so many products. So, it is not uncommon for products are legal in other parts of the world not being allowed in the US due to supporting data not being up to FDA’s standards. Yes, sometimes it is an overkill for some lower risk products but there are also rampant deficiencies in the data presented to the FDA by the manufacturers. Blame FDA as you may but we all benefit when the FDA works as intended. Every country has its own basis for setting standards and since we all chose for FDA to have these standards, we need to abide by them. So, next time some one complains for not getting the Covid vaccine faster, blame the people who control distribution, not the FDA. And please don’t call FDA asking where to get the vaccine; they don’t know.

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: mkumar@fdamap.com
​ Linkedin: Mukesh Kumar, PhD, RAC
 Instagram: mukeshkumarrac 
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