Issues & Insights

With More FDA Reform, Coronavirus Vaccine Needn’t Be A One-Off

With the announcement that Pfizer may be close to a vaccine for COVID-19, there finally may be a light at the end of the tunnel for the coronavirus pandemic. Though still in testing, Pfizer’s latest vaccine promises to be 90% effective in curbing COVID-19. This figure is particularly encouraging, given the Food and Drug Administration’s stated goal of 50% efficacy for coronavirus vaccines.

But, even if this vaccine proves to be successful, there’s a real fear that an incoming Biden administration will tighten approval regulations at the FDA and make it more difficult to develop lifesaving vaccines and treatments in the future. For the sake of millions of Americans with debilitating diseases, a Biden administration must cut the red tape holding back medical innovation.

If Pfizer’s vaccine proves successful, its approval and mass production will be an unprecedented scientific achievement. With the right regulatory policies, this breakneck pace of innovation needn’t be a one-off. Under the status-quo, a medication in the beginning stages of testing has around a 10% chance of eventually being approved by the FDA. And, even if this process is successful, the road is long and arduous. The average cost of getting a new medication approved is now north of $2 billion, and it takes more than a decade to get these products to consumers. One key reason for the high costs, long approval waiting times, and low probabilities of success stems from the FDA’s strict statistical standards for green-lighting lifesaving products. Ordinarily, the agency insists that new medications clear the 95% threshold of statistical significance. In other words, the FDA insists that there’s a 95% chance that the treatment in question is actually effective. 

In order to clear this high hurdle, medical researchers need access to large testing populations and must repeat the same experiments multiple times. Consider that Pfizer used 43,000 volunteers just in the interim phase of its coronavirus vaccine. While studies of widespread diseases such as the coronavirus won’t have as much trouble recruiting large numbers of volunteers, recruiting is more difficult for rarer diseases. Even after a gene therapy called Glybera was approved by the European Union in 2012 for the treatment of lipoprotein lipase deficiency, the FDA declined to approve the product in the U.S. Only around one in a million people have this deficiency, making it prohibitively expensive for manufacturers to find sufficient numbers of volunteers.

The drug’s producer (UniQure) tried submitting modeling attesting to the benefits of its medication, but the FDA was unwilling to stray from its traditional way of doing things. At a time when promising gene therapies are forcing producers to rethink their development processes, the FDA is demanding larger and more complex trials than ever. Tufts Center Deputy Director Ken Getz notes that this increase in protocol complexity is occurring “despite high industry awareness in the adverse impact that protocol complexity has on clinical trial performance,” Getz further argues that “the volume and diversity of data being collected is contributing to high levels of delays and inefficiencies,” despite increased demand for new, lifesaving medications.

Fortunately, Biden could help fix this dysfunctional status-quo. He can and must work closely with FDA Commissioner Dr. Stephen M. Hahn (and his successor) to relax statistical requirements and allow medical innovators some much-needed flexibility. Even with the FDA’s relaxed standard of 50% required efficacy for coronavirus vaccines, companies such as Pfizer are stepping up and offering products far exceeding that threshold. Flexible standards don’t lead to lousy products. Instead, regulatory reform encourages producers to forge ahead with testing promising products even if they aren’t entirely sure how strongly effective their products will be. And that is beneficial for the millions of Americans suffering from devastating diseases.

By pushing for the right reforms, America’s soon-to-be leader can spearhead a new era of medical innovation.

Ross Marchand is a senior fellow for the Taxpayers Protection Alliance.

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