How Low Are the FDA’s Standards of Evidence for New Drug Approval?

Last Updated on October 31, 2022 by Shaun Snapp

Executive Summary

  • There is a great misunderstanding about what standard the FDA uses for new drug approval.
  • We cover the standard they use and the implications.

Introduction

Since its inception, “FDA approved” has carried much meaning. Little known are the basic standards the FDA uses to approve a new drug. Pharmaceutical companies leverage this lack of knowledge to trick the public regarding the effectiveness and safety of drugs.

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The History of the FDA

The history of the FDA is quite interesting and a great jumping-off point to evaluate the modern standards employed by the FDA in drug testing.

A few quotes from the FDA’s website tell the agency’s history.

The Food and Drug Administration is the oldest comprehensive consumer protection agency in the U. S. federal government. Since 1848 the federal government has used chemical analysis to monitor the safety of agricultural products — a responsibility inherited by the Department of Agriculture in 1862 and later by the FDA.

Although it was not known by its present name until 1930, FDA’s modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law a quarter-century in the making that prohibited interstate commerce in adulterated and misbranded food and drugs.

And from Wikipedia.

In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, also known as the “Wiley Act” after its chief advocate.[1] The Act prohibited, under penalty of seizure of goods, the interstate transport of food which had been “adulterated,” with that term referring to the addition of fillers of reduced “quality or strength,” coloring to conceal “damage or inferiority,” formulation with additives “injurious to health,” or the use of “filthy, decomposed, or putrid” substances. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove fraudulent intent.

What comes across very clearly is the enormous amount of lying and unsafe products to the public by private companies.

This historical insight should not be lost on the public. Only the government can be brought to bear on private companies to either provide accurate information or safe products.

As I will show, the objective of private companies since the precursor to the FDA was created under the Department of Agriculture has been to corrupt the agency to sell products that do not work, products that are unsafe, and sold based on false claims.

Wikipedia continues.

After passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of “prescription-only” drugs was securely codified into law by the 1951 Durham-Humphrey Amendment.[1] While pre-market testing of drug efficacy was not authorized under the 1938 FD&C Act, subsequent amendments such as the Insulin Amendment and Penicillin Amendment did mandate potency testing for formulations of specific lifesaving pharmaceuticals.[8]

This did a few important things.

  • First, it brought a large amount of business to physicians. The law required you to visit and pay a doctor if you wanted to access certain drugs. It is likely the 1938 act would have been strongly lobbied for by the American Medical Association. Yes, it increased patient safety, but it provided physicians a guaranteed income stream.
  • Unfortunately, as time passed, the drug companies could manipulate the doctors into prescribing what the drug company wanted.

Furthermore, the quote explains that “pre-market” testing was still not part of the approval process in 1938. This means that many drugs were put on the market and then later had to be removed by the FDA.

Wikipedia continues.

The FDA began enforcing its new powers against drug manufacturers who could not substantiate the efficacy claims made for their drugs, and the United States Court of Appeals for the Ninth Circuit ruling in Alberty Food Products Co. v. United States (1950) found that drug manufacturers could not evade the “false therapeutic claims” provision of the 1938 act by simply omitting the intended use of a drug from the drug’s label. These developments confirmed extensive powers for the FDA to enforce post-marketing recalls of ineffective drugs.

We see very clearly private drug companies attempting to contest that they should have to provide any substantiation for efficacy claims. Think about that for a moment. They fought in court to keep from having to show their products were effective. This provides insight into the mindset of drug companies, which is that they want to sell defective and ineffective medications. The evidence is that they have repeatedly fought in court to do just that.

Pre Capture FDA

This marks a time when drug companies have not yet captured the FDA, and the evidence is its oppositional attitude towards drug companies. Drug companies should be complaining about the FDA. As soon as drug companies praise the FDA or begin talking about their “public-private” partnership, this is when you know the drug companies have captured the FDA. And consequently, the public interest has been sold out. The following support for the FDA by industry should raise suspicions.

Over recent months, the biopharmaceutical industry has been increasingly vocal in its support of U.S. health agencies, including the Food and Drug Administration and the Centers for Disease Control and Prevention, and the scientists who work for them. They’ve committed to follow government guidance on how to report safety and efficacy data on vaccinesand therapeutics — something that hasn’t always needed to be verbalized.

Why be so protective of their government counterparts? Because distrust doesn’t operate in a vacuum. If Americans don’t have faith in regulators and other checks and balances, they’ll lose faith in the products at the end of pipeline, too. – Bloomberg

Yes, that is Bloomberg’s explanation, but Bloomberg is the mainstream media and highly corrupt with many corrupt connections. I explain that the pharmaceutical companies run the FDA and CDC, so they will defend them. This is one example. However, as you will note, it is very rare to hear any complaints about the FDA from drug companies in the modern era. And that is a bad sign for the public interest.

Wikipedia continues.

The 1962 Kefauver-Harris Amendment to the FD&C act represented a “revolution” in FDA regulatory authority.[11] The most important change was the requirement that all new drug applications demonstrate “substantial evidence” of the drug’s efficacy for a marketed indication, in addition to the existing requirement for pre-marketing demonstration of safety. This marked the start of the FDA approval process in its modern form.

This is the process that I will critique later in this article. But note that until 1962 there was no process for submitting a formal clinical trial to the FDA.

Wikipedia continues.

Drugs approved between 1938 and 1962 were also subject to FDA review of their efficacy, and to potential withdrawal from the market. These reforms had the effect of increasing the time required to bring a drug to market.[12] In the mid-1970s, 13 of the 14 drugs the FDA saw as most important to approve were on the market in other countries before the United States.

What this indicates is that the FDA was applying standards. One should not endeavor to approve drugs quickly or to approve them as quickly as other countries.

Wikipedia continues.

Concerns about the length of the drug approval process were brought to the fore early in the AIDS epidemic. In the mid- and late 1980s, ACT-UP and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections, and staged large protests, such as a confrontational October 11, 1988 action at the FDA campus which resulted in nearly 180 arrests.[14] In August 1990, Dr. Louis Lasagna, then chairman of a presidential advisory panel on drug approval, estimated that thousands of lives were lost each year due to delays in approval and marketing of drugs for cancer and AIDS.

This is only looking at one side of the equation, which is deaths due to drugs not being approved.

However, this one-sided view was the death knell for standards at the FDA, and the new lower standards were applied not only to AIDS drugs but to all drugs. Recall from what I covered earlier that companies want to sell ineffective products to the market and will use any excuse to reduce standards. What begins as a “tug at the heartstrings” about dying patients ends with standards being dropped.

Since then, the FDA’s standards have continually declined as the drug companies have controlled the agency more. The intent of food and drug companies is always the same, to sell ineffective and, in many cases, unsafe products to the public.

They found the stamp of approval provided by the FDA to be quite useful. So they want the best of both worlds to sell ineffective drugs based on false claims while being government-approved.

The company Red Bull makes an unhealthy product where the active ingredient is high levels of caffeine. However, Red Bull has aggressive marketing that has daredevils performing various stunts. What this has to do with the product is hard to fathom. The false claim of Red Bull and other energy drinks is that they provide “Energy.” In reality, they offer high doses of caffeine. 

The drug ads are enormously deceptive, and the FDA has little oversight of these advertisements. These types of ads are illegal in most developed countries. The drug ads repeatedly refer to FDA studies, which, as I will show, is a useless indicator for whether the drug is effective. Direct-to-patient advertising is a way to get the patient to prompt their doctor to prescribe a medication they would ordinarily not prescribe. 

How Many Studies Are Required to Obtain FDA Approval for a New Drug?

Many have claimed that there is a lack of scientific evidence for the use of Ivermectin to treat the coronavirus. The claims of the lack of evidence of the effectiveness of Ivermectin for treating coronavirus are made preposterous when one considers how the FDA approves drugs were far less evidence and with the studies, or clinical trials, is entirely run by financially biased parties, which are the pharmaceutical companies.

The following quotation explains the number of studies required.

Generally, the agency expects that the drug maker will submit results from two well-designed clinical trials, to be sure that the findings from the first trial are not the result of chance or bias. In certain cases, especially if the disease is rare and multiple trials may not be feasible, convincing evidence from one clinical trial may be enough. – FDA

The FDA leaves out that the pharmaceutical company runs the clinical trials without any oversight from the FDA. The following quote from the FDA also gives this false impression again.

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