What would America look like without a regulatory body like the Food and Drug Administration (FDA) overseeing and deciding drug safety and approval?
The idea almost seems too radical to entertain. We are accustomed to trusting bodies like the FDA to ensure our safety regarding drugs on the market, corruption from greed, and conflicts of interest. “Is it FDA-approved?” is a rite of passage for many before considering foods and supplements.
Disasters like the thalidomide incident and the elixir sulfanilamide tragedy may come to mind. What about the Dalkon Shield disaster, which resulted in 18 deaths and left thousands of women infertile? Or the Fen-Phen Scandal, where a popular weight loss drug caused around 50,000 cases of heart disease? The costs of some of these incidents are incalculable, as their effects can extend far beyond the immediate — like infertility, miscarriages, chronic illnesses, and even death.
There is an issue with the examples outlined above — did you catch it? The latter two events occurred after the FDA was granted enforcement power through the Food, Drug, and Cosmetic Act (FDCA) of 1938 by Franklin D. Roosevelt. (Some argue that the FDA’s start predates these incidents, with the Pure Food and Drug Act of 1906.)
The FDA serves to ensure safety, efficacy, and security of drugs, medical devices, food, and cosmetics. However, the extent to which this body has actually delivered on these promises isn’t easy to conclude.
The early to mid-1900s was a technological boom for the developed world, and medical breakthroughs were abundant. Vaccines for smallpox — which eradicated the illness in 1980 — diphtheria, rabies, influenza, and whooping cough, among others, were all developed before 1940. The global economic burden vaccines alleviated is undeniable, and the monetary and psychological benefits they bestowed upon the world are immeasurable.
Alongside vaccine development in the early 1900s was the discovery and production of antibiotics. One need look no farther than headlines from the 1940s that hailed penicillin as a “miracle drug.” The birth of hand-washing, potable water, vaccines, and antibiotics has been predicted to have increased human lifespan by roughly 30 years. These discoveries led to a medical revolution in the United States — most of which was accomplished before the advent of the FDA.
Medical history is replete with stories of trial and error, and unfortunately, when concerning human health, tragedy can accompany discovery and breakthrough. The methods utilized today to determine risks and diagnose or detect diseases simply weren’t available. Before the development of methods like the polymerase chain reaction (PCR), scientists lacked the ability to quickly scan vaccine formulations for unwanted genetic fragments from foreign sources. It’s unclear if the establishment of a government bureaucracy would have in any way mitigated these incidents.
The list of tragedies, mistakes, and missteps is extensive, even after the FDCA — the Cutter Incident with the polio vaccine; swine flu vaccines linked to Guillain-Barré syndrome; and, more recently, the opioid crisis, which continues to devastate countless Americans at an astronomical cost. Many of the legislative interventions are applied retroactively, failing to prevent catastrophe.
Furthermore, the FDA has sole responsibility for approving drugs in human trials, but oftentimes it is the pharmaceutical companies that take the blame when these drugs have unwarranted side-effects or unforeseen tragedies. For example, just look at the current lawsuits against Johnson & Johnson — along with a few lesser-known pharma distributors — concerning the opioid crisis. These companies are paying billions in damages for a tragedy that may be better explained by failures within the FDA.
The FDA is granted sovereign immunity; it can be sued or held responsible only in special circumstances approved by the government. Potential conflict of interest, anyone? The FDA also has the power to initiate litigation against pharmaceutical companies for issues such as off-label drug use. These lawsuits are often framed by the media with anti-corporate rhetoric, portraying pharmaceuticals as driven by greed and unethical practices. This only further sows distrust in the medical establishment.
It’s astounding that Americans, who once prided themselves on a free-market approach, have become so dogmatic about the FDA’s role in deciding how to handle our health and medical care. The idea of stripping the FDA of at least some of its responsibilities strikes strong emotions. “Regulations are a good thing!” is often the retort. But what about overregulation? What about all the regulations we’ve implemented since 1906? Do we really need more bureaucracy?
Private medical enterprise has a system of checks and balances that could serve to provide safety, accountability, and affordability. Health care companies, insurers, doctors, and pharma could work together to decide what is best for patients. This would require doctors to be more involved in current medical literature and embolden them to make medical decisions. Doctors are also more closely connected to their patients — which could help prevent disastrous side-effects. A breakdown of regulatory bodies would also help revitalize the free market, increasing competition and decreasing prices. The free market provides an element of accountability ethically as well as fiscally for companies. External auditors, lawyers, and medical associations could all work to help keep pharma accountable.
I’m not arguing for the complete abolition of the FDA. However, its role could shift. The establishment could play a role in helping embolden the free market and protect pharma from frivolous lawsuits. State and local governments could aid in this venture instead of having massive federal oversight.
Rather than clinging to an overreliance on a singular regulatory body, it’s time to explore a more nuanced approach, where private medical enterprises, in collaboration with health care professionals, can contribute to decision-making processes. This approach would foster greater accountability, innovation, and competition in the marketplace, ultimately leading to better patient outcomes and more affordable health care. The FDA’s role should be redefined — not abandoned, but recalibrated to ensure that it complements, rather than controls, the health care system. Now, more than ever, it’s essential that we embrace the free market’s potential to enhance our health while ensuring safety and accountability through transparent, collaborative efforts.
Image via Pixabay.
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