Most people don’t know that the FDA is not a proactive watchdog group. By design, they only get involved when there is a problem, and by that time it is often too late as thousands have died and tens of thousands more have been harmed in various ways.
But many people still believe that the US FDA protects them from anything dangerous in our drug and food supplies. That is far from the truth. The fact is that when the FDA approves a new drug for public use for instance, it has not necessarily studied that drug’s safety research. The agency relies on information from the drug manufacturers to make its approval decisions. I don’t know about you, but that seems a little like the fox guarding the hen-house. Additionally, the FDA does not test the safety of ingredients in cosmetics, food, and personal care products either. They wait until enough people get injured, and then they may investigate.
Also, in the United States up to 99% of the ingredients in some products can be withheld from labels under the trade secrecy laws if they are categorized as “inert.” Most inert ingredients are in bug sprays, insect repellents, and other pesticide products. Toxins expert, Doris J. Rapp, claims that at least 200 chemicals classified as inert are environmental pollutants hazardous to human health.
These laws have enabled the chemical industry to obscure its operations under a shroud of secrecy that has hampered efforts to protect public health. Due to these trade secrets, it is nearly impossible to get complete information about these chemicals even for physicians treating poisonings.
Also, consider the many pharmaceutical drugs over the years that have ended up killing or harming so many people before they were finally recalled from the worldwide marketplace - one hundred and seventy-five of them! Also contributing to the ADR (Adverse Drug Reaction) events is the fact that in 1992 the FDA established PDUFA (Prescription Drug User Fee Act), which established an application and processing fee to be paid by the pharmaceutical drug companies applying for approval of a new medication. Drug companies could get approvals through the regulatory pipeline faster, and patients would get new drugs more quickly. Previously, the FDA was taking too long for the drug approval process because it was underfunded and understaffed, and the pharmaceutical industry and even some consumer advocacy groups (supported by the pharmaceutical industry to the tune of $116 million per year) were getting frustrated with the delays. That sounds like a good problem to solve; but there may be a dark side as well. PFUDA puts FDA squarely in the hands of the drug companies who, considering the exorbitant application fees, expect a quick approval for drugs that may not have even been tested properly.
Since the FDA does not do drug safety or efficacy testing, they only require seeing and reviewing testing results from the drug companies themselves, or from outside research groups that support the claims. The standard application fee was $100,000 in 1993. In 2012, the fee for filing a new drug full application with clinical data was $1,841,500.
In 2018, the FDA fee for a full application was $2,421,495 for applications requiring clinical data, about a 30% increase over 2012. In 2017, the FDA collected $837,500,000 in user fees for prescription drug approvals. This, in essence means that the drug companies are now “funding” about 75% of the FDA’s drug review budget. There would certainly be an expectation by the drug companies to get the approvals. In 2008, the FDA rejected “never-before- marketed drugs” 66% of the time. By 2015, the rejection rate had dropped to 4%. Regulatory agencies should not need to depend on the industry that they regulate for their budget.
As patients or their insurers shell out millions of dollars for unproven drugs, manufacturers reaped the windfall. For them, expedited approval can mean not only sped-up sales, but also, if the drugs are intended to treat a rare disease or serve a neglected population, FDA incentives worth hundreds of millions of dollars can be thrown in. “Instead of a regulator in a regulated industry, we now have a partnership,” said Dr. Michael Corome, former US Department of Health and Human Services official. “That relationship has tilted the agency away from a public health perspective to an industry friendly perspective.”
The FDA approved 46 new drugs where the chemical structure hadn’t been previously approved in 2017, the most in at least fifteen years. In that same year, the FDA’s Center for Drug Evaluation and Research denied 19.7% of all applications for new drugs, biologics, and efficacy supplements, down from a 2000 peak of 59.2% in 2010. In return for accelerated approval, drug companies commit to researching how well their drugs work after going to market. But these post-marketing strategies can take 10 years or longer to complete, leaving patients and doctors with lingering questions about their safety and benefit. “Clearly accelerated approval has greater uncertainty,” says Dr. Janet Woodcock head of FDA’s Center for Drug Evaluation and Research.
The more the FDA relied on industry fees to pay for drug reviews, the more it showed an inclination towards approval, former employees say. “You don’t survive as a senior official at the FDA unless you’re pro industry,” said Dr. Thomas Marciniak, a former FDA medical team leader, and longtime outspoken critic of how drug companies handle clinical trials. “Nobody gets congratulated for turning a drug down, but you do get seriously questioned if you do,” said the former staffer. Higher-ups would also send congratulatory emails to medical review teams when a drug was approved.
In his book Overdose, Dr. Jay Cohen quotes a study by three university professors in the Journal of American Medical Association that determined that at least 51% of all FDA approved drugs “have serious adverse effects not detected prior to approval.” This revelation prompted Cohen to write, “Think about this: more than half of our drugs, after being deemed safe by the FDA and then prescribed to millions of people, are subsequently detected to have previously unrecognized medically serious side effects.”
You can find out much more in my book Your Health Has Been Hijacked available here on my website. Click on the link below.
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