Thursday, September 26, 2019

FDA - impossible mission


The Food and Drug Administration (FDA) is the regulatory body tasked with insuring the safe human consumption of ggods and services across multiple industries and sectors. Given the size of their budget, their number of employees and the scope of their regulatory responsibility the FDA has an impossible mission. This places our nation at tremendous risk. The swipe of a pen by one irrational person could result in catastrophic social disruption. It is the greed of our free market and unlimited political contributions that created this urgent national security issue and allows for it to persist in plain sight. 

In simple terms the FDA is a regulatory body that ensures safety of 75% of our nation's foods supply, and 100% of: cosmetics, medication, tobacco, radiation producing products, medical devices, animal foods and medications, vaccines, blood and biological products.  Just in terms of food the FDA regulates about 75% of the food supply with the exception of meat, poultry and eggs that is regulated by the USDA. This includes more than 25,000 pet food products and 193,377 human food products that are produced by more than 35,000 farmers distributed by more than 300,000 restaurant chain locations and more than 10,000 vending machine operators that all full under the FDA's regulatory responsibility. The FDA is accountable for all foods produced, sold and consumed in the United States even if they are manufactured overseas. This includes food ingredients and additives. That means food products, ingredients or additives that are manufactured in Russia and later sold and consumed in the US are subject to FDA regulations. There were a total of $137.2 billion in food sold during 2017 plus another $21 billion dollars of beverages, $34 billion worth of animal food and 81.4 billion dollars of plant food for a total of $273.2 billion dollars of only imported food products that are marketed and consumed in the US in 2017. This does not include $38 billion in milk that was purchased in 2017 from domestic sources the FDA also insures is safe for public consumption or any other domestically produced food that is not chicken, eggs or meat. There was a total of $754 billion dollars spent on food and beverage at retail stores in the US during 2018. The US spent approximately $1.7 Trillion on food in 2017.  Chicken, eggs and meat fall under the scope of the United States Department of Agriculture (USDA). 

The FDA also regulates medicines, both prescriptions and over the counter medications as well as vaccines, cellular and gene therapy products, blood and blood products and medical tissues and tissue products. They also oversee medical devices such as; bed pads, pacemakers, prosthetics, hip replacements and other surgical implants. The Food and Drug administration must also govern products that produce radiation such as microwave ovens, x-ray machines, lasers, ultrasonic (ultrasound) therapy equipment, sun lamps and more. The FDA's roles is not strictly limited to human consumption. The FDA also oversees veterinary drugs and devices. In 2018 the total dollars spent on pet food and over the counter medication for pets totally $46 billion dollars. This does not include livestock feed or medication or devices that would also fall under the purview of the FDA. 


In 2016 there was $329 billion dollars spent on prescription medications of the 3.3 trillion dedicated to the national health expenditures of the United States. There was $35 billion spent on over the counter medication for humans in 2018. Then there is at least another $40 billion dollars of durable medical equipment sold during that same year. 


The FDA is also tasked with the regulation of cosmetics sold in the US that is at least another $17 billion of products sold in 2018. Then there are the $258 billion in tobacco products, $3 billion in vaping products, $10 billion of x-rays machines sold and $7 billion in biologics that include things like blood, cells, tissues and other products produced by living things such as certain medications. This is far from a complete list, there are still many products and markets that fall under FDA jurisdiction. The long list of industries that fall under the FDA umbrella is only growing. Just today the FDA clarified their role in the regulation of artificial intelligence and digital medical devices. 

In total the FDA is responsible for the oversight of more than $2.5 trillion in consumption of food, medical products, and tobacco. What would be a reasonable budget to provide oversight for $2.5 trillion dollars in goods? Believe it or not the total FDA budget for 2018 was $5.36 billion dollars. That might sound like a lot of money but lets put that into context. 

Remember that chicken, eggs and meat full under the USDA and not the FDA. IN 2017 there were $7.55 billion worth of eggs sold in the US, 43 billion pounds of chicken consumed at an average cost of $1.50 per pound is $64.5 billion in chicken sales and consumed another 58 billion pounds of turkey, beef, pork, lamb and veal at and average cost of $4.00 per pound is total sales of approximately $232 billion for a rand total of $304 billion dollars in total sales of chicken, eggs and meat sold in the US. The total budget for the USDA dedicated to the regulation of this part of the food supply is "more than $1 billion."   The FDA is tasked with the oversight of $2.5 trillion dollars in products 8 times that of the USDA with a total budget of $5.36 billion dollars. 

Why is this budget short fall based on greed of the open market? Because the industry is supposed to fund the regulation of the industry. It is not supposed to be the responsibility of the consumer to insure that the products they are buying are safe to consume. The companies that earn a profit from the sale of the product that are supposed to insure that their product is safe. This is very common practice across most industries. A nurse is regulated by a state board that is funded by licensing fees, administration fees and other fees that the nurse must pay to the regulatory body in order to participate in the industry. Drug manufactures are no different. They need to pay fees to gain required approvals, they must maintain certification and licenses or get permits to remain FDA complaint.  The companies, drug manufactures, big tobacco, giant commercial farms have so much money and power that the have played the political system to put the consumer on the hook for a greater and greater portion of the funding for oversight of their respective industries each political cycle. These big companies spend big money helping people get elected and government oversight is a common political tool used to gain favor with those that make especially large donations to campaigns.  

The private section, or free market, continues to lobby for less and less regulation and decreased taxes and fees associated with the cost of doing business placing a greater burden on the tax payer to fund the FDA. In 2018 one drug company, AbbVie sold $13.6 billion dollars worth of one medication, Humira that treats inflammatory arthritis, Crohn's Disease and ulcerative colitis. There are approximately 4 million people or about 1.2% of the population that can benefit from this medication. The lack of funding for the FDA is the direct result of these companies working to drive up profits and force down cost. That is the legal requirement of for profit companies. They are legally required to take every action they can to build profits. The FDA should have the ability to adjust fees to accommodate its budget needs but they face the threat of increased consumer cost to cover those fees. This is how greed creates the budget short fall and insure it will continue into the future due the political conundrum manifested by unlimited corporate dollars supporting political campaigns. If the politician is going to survive they must serve their corporate donors to insure that the life giving supply of cash continues. 

How could the oversight of food and drugs be a national security risk? That requires even more numbers to fully explain clearly. Currently "80% of active pharmaceutical ingredients manufacturers are located outside of the U.S." 

The US is heavily dependent upon foreign governments to supply 80% the ingredients used to make medications. It is possible that one government employee could touch off a trade war with one nation that could cripple our pharmaceutical industry with the stroke of a pen. There are 67,000 pharmacies in the US and only 17,000 full-time equivalent employees at the FDA.  There are more than 14 million shipments of food imported into the US every year that those same 17,000 employees that oversee the 67,000 pharmacies need to inspect. Obviously that is not possible that is why the FDA estimates that approximately 2% of food imports are inspected. This is not a secure supply chain. One batch of dirty spinach can put dozens of people in the hospital. What would be the ramifications of a political adversary interrupted the import of food and the active ingredients used to manufacture medications? The cost of food and medication would sky rocket quickly creating a social disruption the US has never seen but has imposed on other nations. These actions are called sanctions. China could easily impose sanctions that prevent companies in China from selling the US food and medicine. That is the same action the US has taken against several of our political adversaries over the years. They are only effective if the nation is dependent on imports to meet the needs of their people. These are few of the ways that a lack FDA funding over a number of years has given rise to this national security crisis. 





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