By Christina Herrin
COVID-19 has upended our lives and highlighted government incompetence, but it is also necessary to showcase the government’s successes during the pandemic. Perhaps the greatest example has been the Trump administration’s Operation Warp Speed, which worked to quickly develop a vaccine for the virus.
This no-nonsense approach showed what can happen when the government reduces red tape and allows our top scientists and researchers to do allow what they do best: develop cutting-edge solutions to keep people alive and healthier.
Despite the fact that taxpayers had to spend billions of dollars to convince drug makers that developing a vaccine would be worthwhile, economic analysis by economists at the University of Chicago (see related article, page 9) shows “vaccinating the population against COVID-19 six months earlier was worth about $1.8 trillion to the U.S. alone, in terms of lives save and accelerating the return to normal schooling, work, socializing.” Spending is all about priorities, and in this case, the choice was a wise one.
Given the overwhelming success of Operation Warp Speed, one cannot help but wonder if it’s time the federal government lightens up on the drug regulatory process altogether. On average, it takes 12 years and $2.9 billion to bring a drug from lab to market.
Free to Choose – A Solution
A good first step is to implement a policy proposal known as “Free to Choose Medicine (FTCM).” This approach would apply free-market principles to the draconian drug approval process by allowing patients to have access to therapies before they have received the gold stamp of approval from the FDA.
Under FTCM, the choice to try an experimental treatment would be up to the patient, not government regulators—the kind of idea that might have been championed by the late “free to choose” economist Milton Friedman. FTCM would create a pathway for patients who have exhausted all other treatment possibilities and want access to unapproved, yet potentially life-saving, therapies. Once a drug is demonstrated to be safe, drug companies could test its efficacy in the open market. Currently, efficacy testing is done in stages in controlled trials, a process that can take years, and trials are done on limited populations.
Currently, Right to Try (RTT) legislation aims for a similar goal, but this approach is internally flawed because it doesn’t provide a market incentive for a biopharmaceutical company to bypass efficacy testing. The goal of drug regulatory agencies should be to allow good drugs to succeed sooner, and bad drugs to fail faster.
Similarly, the federal government needs to allow the free market to explore new uses for existing drugs. Drug agencies have blocked these efforts with COVID a point made repeatedly during the hearings in November and December on early outpatient COVID treatment before the U.S. Senate Homeland Security and Governmental Affairs Committee. Because there is limited profit potential for the private market to do the required testing on new uses for generics, the federal government may need to step up. However, at the very least, the federal government should get out of the way and give the decision-making power to health care providers.
America should be front and center, leading the world in the development of state-of-the-art drugs and treatments. But unfortunately, FDA’s arbitrary regulations blunt the development of timely, affordable drug development. It is time for the FDA to act as a bridge to innovation and build off the success of Operation Warp Speed, which has shown drugs can be developed in record time if regulators get out of the way.
Christina Herrin (CHerrin@heartland.org) is the government relations manager of health policy at The Heartland Institute. A version of this article appeared on Townhall.com on January 29. Reprinted with permission.