On October 22, the U.S. Food and Drug Administration (FDA) announced the approval of Veklury, commonly known as Remdesivir, a therapeutic treatment for COVID-19. The approval is a landmark event because it is the first drug to receive full approval by the FDA in the fight against the coronavirus.
According to a statement by FDA Commissioner Stephen Hahn, “The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency. Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”
Hahn is right, the approval of Remdesivir is a battle victory in the greater war against COVID-19. Before issuing full approval, the FDA performed their due diligence, conducting three clinical trials. The results of all three clinical trials showed significant improvement for COVID-19 patients who took Remdesivir.
According to one of the three double-blind, placebo-controlled clinical trials, “The median time to recovery from COVID-19 was 10 days for the Veklury group compared to 15 days for the placebo group, a statistically significant difference. Overall, the odds of clinical improvement at Day 15 were also statistically significantly higher in the Veklury group when compared to the placebo group.”
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The other two clinical trials, which included thousands of patients in weeks-long studies, showed similar results.
The FDA’s study and approval of Remdesivir, which occurred in just over seven months, is a remarkable achievement.
Prior to the pandemic, the FDA’s timeline to approve new drugs averaged more than a decade. As many have argued, the FDA’s drug approval process is outdated and laden with bureaucratic red tape. It is in dire need of reform.
According to Bartley J. Madden, author of Free to Choose Medicine, “Deaths from an approved drug become a top story for the nightly news and can lead to Congressional inquiries. Avoiding such negative publicity is the overriding goal of the Food and Drug Administration (FDA). The resulting extreme tunnel focus on safety causes delayed access to innovative drugs, which in turn causes millions of people to suffer and many to die needlessly.”
To be fair, the FDA is in a difficult position. On one hand, they must ensure that drugs are safe. On the other hand, the process has become so burdensome that millions of Americans are unable to even try drugs that could literally save their lives, simply because the approval process is so timely and costly.
As Madden writes, “When drug development, testing, and market access to drugs are viewed as a system, it is clear the appropriate system goal should be better drugs, sooner, at lower cost. However, ‘sooner, at lower cost’ is ignored by FDA while it demands ever more testing. Today, a pharmaceutical company spends 10 years in clinical testing for a new drug in hope of securing FDA approval. The total cost of an approved drug is about a billion dollars.”
If the coronavirus pandemic has taught us one thing, it is that the FDA’s drug approval process needs to be overhauled.
Fortunately, there are several reform strategies that are already on the table. Right to Try and Free to Choose Medicine are just a few of the possibilities.
In the wake of the coronavirus pandemic, FDA officials ought to consider at least some of the commonsense reforms that would improve access to drugs that could literally save thousands of lives every year.
Chris Talgo (ctalgo@heartland.org) is an editor at The Heartland Institute.
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