From nationwide shutdowns to metropolitan lockdowns, the coronavirus and its ensuing panic have culminated in a controversial and far-reaching government response. But there has been one bureaucracy that has actually been called into question, rather than reaffirmed, in light of this pandemic: the Food and Drug Administration and its tedious drug approval process.
The FDA was founded in 1906 in response to gruesome and unsanitary conditions in the meat-packing industry. It has since become the unquestioned arbiter of all new medical innovations. FDA approval is now essential for doctors to prescribe and insurance companies to cover any new drug, test, or procedure.
While ensuring the safety and efficacy of new medications is indeed important, the FDA’s monopoly on drug approval has morphed into a sluggish, bureaucratic nightmare, requiring an average of 12 years for new drug approvals. That’s 12 years during which rapidly-progressing cancer patients or sufferers of rare diseases may unnecessarily suffer and perish.
Yes, the FDA may be somewhat faster than some of its European counterparts, but drugs typically hit U.S. markets first anyway because that’s where their profit margins are greatest.
It stands to reason that if the United States is already paying three times more for the latest medical innovations, citizens should at least have the right to try life-saving drugs as early as is medically safe. And there is no reason why one single government agency should be the “be all and end all” when it comes to evaluating medical innovations, especially in a nation that boasts so many of the most advanced health organizations, research centers, and acclaimed medical professionals who could offer equally sound, if not better, suggestions to doctors and consumers.
Never has the FDA’s tepid bureaucratic pace been more dangerous than when a global pandemic such as the coronavirus catches the world woefully unprepared.
Without a doubt, the weight of the pandemic has thankfully sped up the typical FDA approval process, with a new commercial test for the disease just being approved on March 16. Prior to this, the only tests available had been the government-manufactured ones, which have proven to be rather inaccurate and in pathetically short supply. Had the commercial test been approved even several days earlier, the effect on the spread of the disease could have been significant.
Moreover, with several pharmaceutical companies (Sanofi, Regeneron, Gilead, and Moderna, among others) working overtime to get antiviral drugs and vaccines manufactured and tested for the coronavirus, it is more imperative than ever that these innovations get approved and hit patients as soon as possible. The coronavirus, which has as of writing this claimed 6,500 lives worldwide, does not wait for any government bureaucracy.
Adam Barsouk is a medical student, cancer researcher, and writer whose work has been published in Forbes, the Wall Street Journal, Newsweek, and more.
