Health Care

The FDA Is Stifling Pharmaceutical Innovation

Scientists work in a lab testing COVID-19 samples at New York City’s health department in New York City, April 23, 2020. (Brendan McDermid/Reuters)
Mary Ruwart’s Death by Regulation gives many shocking — and telling — examples.

“Power tends to corrupt and absolute power corrupts absolutely.” — Lord Acton

I started looking into the Food and Drug Administration (FDA) when I found it is preventing America from effectively responding to the COVID-19 epidemic. By blocking businesses and schools from using cheap, fast tests that could enable them to identify and send home COVID carriers, the FDA is stopping us from employing a technology that would allow us stay open while crushing the pandemic.

Is this an isolated case of malfeasance by the FDA? Or is it part of a consistent pattern?

In further researching the matter, I encountered numerous reports of similar past instances, but nowhere were they better analyzed and summarized than in the 2018 book Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It. Written by former Upjohn research scientist Dr. Mary Ruwart, the book is a comprehensive — and frankly shocking — indictment of a federal bureaucracy gone mad.

The FDA was established in 1906 by the Pure Food and Drug Act, but it was relatively harmless until its powers were radically expanded in 1962 by the passage of the Kefauver–Harris amendments that gave it absolute power over the pharmaceutical industry. As documented extensively by Ruwart, since that time, the FDA has indulged in ever greater abuse of these powers, inflicting alarming harm on America — and humanity at large — in the process.

By radically and continually expanding the paperwork, testing, and other legal and regulatory obstacles to bring a new drug to market or treatment to practice, since 1962 the FDA has caused the development time for new drugs to triple (from an average of four years before the amendments to twelve today), the cost to multiply 40-fold, and the number of new drugs introduced per year to be cut fivefold. Within five years of the amendments’ passage, 98 percent of U.S. drug companies (including all the small innovative ones) were eliminated from the drug-development business. Before the amendments, 50 percent of all new drugs invented worldwide were developed in the U.S. Today, it is 15 percent. Not only that, many new life-saving drugs have been kept out of the United States for as many as 20 years after they were put into use in the U.K. or Europe.

One such FDA stall was the agency’s banning in the 1980s of life-saving European anti-AIDS drugs, denying readily available treatments that could have saved hundreds of thousands of lives. This ban provoked underground resistance (depicted in the 2013 movie The Dallas Buyers Club) and eventual successful legislative reversal by the gay-rights movement. But sufferers of numerous other diseases without such effective political organization were not so lucky.

In fact, according to the figures assembled by Ruwart, the total number of deaths caused by FDA delay of approval of drugs for treating heart conditions, cancer, diabetes, and numerous other ailments is at least 15 million — or more than ten times the total number of American combat deaths in all of our wars since 1775, combined.

Unfortunately, the amendments not only give the FDA the power to approve drugs, they grant it the power to control what companies can say about drugs. The FDA has maintained (and the courts have supported its position) that, regardless of what the Bill of Rights might imply, it has the power to control “commercial speech” on all matters concerning foods and drugs. This ability to control speech, and thus knowledge, has had disastrous consequences.

Aspirin is a prime example of this. Medical researchers knew in the 1960s that aspirin, on sale in the U.S. since 1899 as a pain reliever, could also be effective in averting heart attacks. In 1969 the Squibb company asked the FDA for permission to have its sales representatives inform doctors about this new “off-label” application for this widely available inexpensive drug. The FDA refused and threatened to prosecute any drug company that made any such statements unless and until they conducted billions of dollars’ worth of tests to verify that conclusion to the FDA’s satisfaction. Because aspirin could not be patented, no company was willing to conduct those tests, and the treatment remained unknown until 1989, with millions of Americans dying needlessly of preventable heart attacks as a result.

The FDA repeated this reprehensible action by forbidding dissemination of the knowledge that folic acid (a cheap B vitamin) could prevent a large class of birth defects, thereby causing tens of thousands of babies to be born with horrible and easily preventable deformities — an affair Ruwart justly calls “the American thalidomide.” (Thalidomide was a drug used in Europe in the early 1960s that caused birth defects. It was never used in the U.S. because the limited tests mandated by the pre-amendments FDA were readily able to identify it as unsafe. Testing for drug safety is relatively cheap and quick, and clearly worth doing with new drugs. The problem is that the post-amendment FDA also required testing for drug effectiveness prior to use — even for new uses for older, demonstrably safe drugs. This can take many years and is open to endless dispute.)

The problems don’t end there. The nature of science is such that several major drug companies are frequently working on minor variants of the same new drug. The drugs may be virtually identical, but whichever company is allowed to reach consumers first will typically obtain at least 80 percent of the market. The FDA can decide the outcome of such billion-dollar-stakes competitions at a whim, simply by sitting on one company’s paperwork for a few extra months. Not that the agency can’t be reasonable about such matters. If a company is willing to pay the FDA directly, the agency will help speed things up by adding personnel to the force it assigns to sifting through the truckloads of documents it requires for each new drug application. The bill for this service is typically over a million dollars for each extra person. Given the billions at stake, pharmaceutical companies apparently consider that a bargain — so much so, that the FDA now obtains more funds though this racket than it does from Congress. Of course, it doesn’t hurt if a company can also make clear that it is willing to provide FDA officials with plush jobs at their firm after they retire from government. So everyone wins, except those who can’t pay to play, and of course, the public.

Under the circumstances, it should not be surprising that the FDA opposes letting companies with vitamin supplements, fish oil, elderberry syrup, or similar items (even walnuts!) inform the public about the benefits of their products — to the point of launching SWAT team raids on their facilities — unless and until they pay the agency its extortionate tolls. As a result, unless a company has the billion-dollar treasuries of the largest pharmaceutical companies at its disposal, it can’t properly market its cheap remedies for all sorts of conditions.

Not only that, the FDA actively spreads disinformation against vitamin cures that are well-established. For example, it has been known to medical science since 1920 that rickets, a debilitating skeletal disease, can be cured by vitamin D. Yet the entirely true claim on my vitamin D bottle that it “promotes healthy bones” also contains an asterisk, leading to a boxed rebuttal by the FDA, stating “this claim has not been verified by the Food and Drug Administration.”

By adding to development costs and creating monopolistic conditions, the FDA has enormously increased the costs of drugs. This has harmed all Americans greatly. If you have health insurance, you might be unaware of this, because you only have to make a small co-pay — say $10 — when you pick up some medicine at the pharmacy. But your insurance company might well be paying $500 to cover the cost of your little bottle, and that cost comes right back to you, and everyone else, in the form of soaring insurance premiums. It’s possible you might be not be aware of those premiums either, because your employer is paying them. But if so, that cost is ultimately coming right out of your paycheck.

The FDA’s crimes are not limited to those against humans. Despite advances in medical technology that would allow trials of new drugs to be conducted in test tubes (“in vitro”) instead of animals (“in vivo”), the FDA has vastly multiplied its requirements for animal testing, requiring pharmaceutical companies to waste many years and billions of dollars of development time and cost to subject millions of animals to massive overdoses of experimental drugs. The painful mass sacrifice of these helpless creatures provides no benefit to human health. On the contrary, it not only serves to delay availability and increase the cost of critical remedies to human consumers, it eliminates many valuable potential cures without proper justification. In fact, as Ruwart details, had the FDA’s current animal-testing rules been in place in the past, many drugs in common use today, including aspirin, never would have been allowed to reach market.

But the worst is yet to come. By enormously inflating the development cost of new drugs, the FDA is not only limiting the number of new drugs that get to market, it is stopping altogether the development of certain essential types of drugs. If it costs billions to develop a new drug, a company will focus its efforts on drugs that users will need to keep consuming for years, such as AIDS remedies. It will not spend its funds for a medicine that someone will use only for a few days or weeks, such as antibiotics. This is a potential catastrophe in the making. As a result of the introduction of antibiotics, the American death rate from infections has fallen 95 percent over the past century. But bacteria are mutating all the time and becoming ever more resistant to our existing antibiotic arsenal. We need to be developing new antibiotics all the time, and if the FDA is not gotten out of the way, we could be left helpless against a deadly pandemic caused by a drug-resistant superbug.

Americans make up 4 percent of the world’s population, but over the past century, they have been responsible for 50 percent of all inventions. The latter is no longer the case with respect to pharmaceutical innovation. If the FDA is not reined in, tens of millions of Americans — and hundreds of millions worldwide — could die of easily preventable causes.

Ruwart’s remedies include repealing the amendments and reforming the FDA to limit its power to banning drugs proven to be unsafe, with no say, other than its own certification, regarding a drug’s effectiveness. That is, any drug not proven to be unsafe should be legal for sale, with the FDA offering certification of those it has found to be effective, but no authority to ban drugs it has not, or to ban speech it has not verified. Uncertified drugs should be legal for sale, provided their label carries the caveat that “the effectiveness of this drug has not been demonstrated to the FDA.” It could, however, carry endorsements from other authorities, such as the American Medical Association. People would be free to take or leave such advice, as they prefer, but no one would be denied the right to defend their health as they see fit.

Looking at our current pandemic situation, such measures could not be more timely.