The Food and Drug Administration (FDA) has acted quite maliciously towards Kratom by continuing to spread misinformation about Kratom despite a plethora of peer reviewed scientific studies which have proven that Kratom is safe and has efficacy in ending addictions to synthetic opioids and opiates. The likely reason for the FDA’s behavior is that they get roughly $1.2 billion per year from Big Pharma, mostly for the drug approval process, influencing the FDA to do what Big Pharma wants, and since Kratom is competition to prescription synthetic opioids, the FDA is trying to get rid of Kratom.
According to the FDA, their annual budget is $5.7 billion, with $3.1 billion being given to the FDA by the Federal government and the other $2.6 billion coming from industry and user fees. The FDA is in charge of a lot of other stuff besides drug approval, but human drugs are the biggest part of their budget relative to their other activities, and comprises 33% of the total budget.
Out of the 33% of the FDA budget that is dedicated to human drugs, 65% of this is paid by Big Pharma. This comes out to over $1.2 billion per year that Big Pharma pays to the FDA.
A lot of this money is from the Prescription Drug User Fee Act (PDUFA), where the FDA requires Big Pharma companies to pay $2.42 million to create a full application for a new drug if it involves clinical trials, and $1.21 million to apply for a new drug with no clinical trials or a supplement with clinical trials.
FDA budget data indicates that these fees paid by Big Pharma have been increasing by hundreds of thousands of dollars per year per new drug application, and in general the amount of money the FDA makes each year from these new drug approvals is increasing by tens of millions of dollars per year, as fees increase and the rate of drug applications increases.
Before 1992, when PDUFA was passed, the FDA did not operate like this, probably because it is obvious that turning the FDA into a money making business would lead to the FDA being biased.
Thus, the FDA makes over $1.2 billion per year from fees paid by Big Pharma, mostly from fees to approve new drugs, and this likely biases the FDA to do what Big Pharma wants, including banning Kratom since Kratom is a competitor to the prescription opioid industry and cuts into Big Pharma’s profits.
Indeed, there is no other rational explanation as to why the FDA would want to ban Kratom, which has caused zero scientifically proven deaths, while supporting prescription opioids, which kill tens of thousands of people in the United States every year.
Unfortunately, money is being chosen over lives by the FDA. Clearly the government should get rid of PDUFA so that the FDA no longer is funded in any way by Big Pharma, and if that happens perhaps the FDA will begin acting like unbiased scientists, which was how the FDA used to operate from its founding in 1906 until the early 1990s when PDUFA was passed.
Perhaps this issue is the way forward to winning the Kratom fight, since if PDUFA was repealed, the FDA would no longer have any incentive to try and ban Kratom.