FDA Can Move More Swiftly When Time is of the Essence

August 23, 2021
By Naomi Lopez

The FDA can sure move swiftly when it wants to. We learned that earlier today, when the U.S. Food and Drug Administration (FDA) fully approved the Pfizer-BioNTech vaccine for COVID-19. This approval took months rather than years, with the FDA cutting red tape to speed the approval process. Now, it should adopt the same approach to approving treatments when terminally ill patients’ lives are on the line.

The FDA’s rapid full approval is a tacit demonstration that the FDA has the ability to move quickly. That same sense of urgency and fervor should be the approach taken with those diseases and illnesses for which there is not yet an FDA-approved treatment.

The FDA’s approval process takes an average of ten years to bring a treatment to market, leaving the vast majority of patients who have exhausted FDA-approved treatments to rely on treatments that were developed many years or even decades ago – or they are told to get their affairs in order. Through reforms, these patients can and should receive the same attention and commitment that we have seen for treatment development during this pandemic.

To build upon the success of more rapid and still thorough clinical evaluations, the U.S. can and should embrace the technological capabilities in information as well as treatments. Currently, the FDA reviews manufacturing processes as well as re-analyzes the raw data from clinical trials (as opposed to the submitted manufacturer data) and other sources (rather than topline data, which is the practice in other countries). The European Medicines Agency, for example, reviews data on a rolling basis, and while it is true that the FDA evaluates a broader swath of data, these in-depth reviews too often rely on decades-old information capacity that is failing to keep up with 21^st century capabilities.

Congress has already directed the FDA to use more Real-World Evidence in its clinical evaluations. In our newly released blueprint for healthcare reform, the Goldwater Institute offers proposals for unleashing the full potential of treatments by further removing bureaucratic obstacles and barriers.

The FDA has pivoted from business as usual when it comes to ensuring that we can keep the public safe and the economy moving during COVID. This is an important first step to do the same for the many patients who are running out time while waiting on the outdated FDA approval process. We already have the opportunity to bring this same sense of urgency for these patients to ensure that the right treatment will be available to the right patient, and at the right time.

Naomi Lopez is the Director of Healthcare Policy at the Goldwater Institute.