April 6, 2020
By Naomi Lopez and Jon Riches
With no FDA-approved vaccines or treatments for COVID-19, speed in finding treatments is essential. The U.S. Food and Drug Administration (FDA) should be lauded for moving quickly to begin clinical evaluation of potential vaccines and treatments for this virus. Most recently, the agency announced a new, accelerated program, the Coronavirus Treatment Acceleration Program (CTAP). This initiative promises to both help expedite the clinical evaluation process and provide pre-approval patient access to these treatments.
But if this FDA initiative is similar to some of the agency’s others, then we should work to ensure that this program operates with openness, fairness and transparency in how the FDA determines the select few patients who are granted permission to investigational drug treatments that could save their lives.
The FDA’s lack of transparency regarding the drug approval process, particularly in an emergency, is well-documented. Take, for example, the Goldwater Institute’s legal challenge to the FDA’s refusal to release information about how it made lifesaving drugs available during the Ebola crisis in West Africa.
When the world was facing the prospect of this pandemic in 2014, two American aid workers who had been treating Ebola victims in Africa became infected, and thanks to a rapid FDA authorization, they were treated with the investigational drug ZMapp which had, at that time, never been tested on humans. Fortunately, both survived.
As the ultimate arbiter of who has the chance to try to save their lives when the FDA decides who can access these investigative treatments, Americans have a right to know the FDA’s process for determining who gets access to investigational treatments and why.
The drug approval process in the United States should not be a government secret. That is why the Goldwater Institute took the FDA to court. Almost five years later, the U.S. Court of Appeals for the Ninth Circuit ruled that in favor of the Goldwater Institute, finding that the FDA could not hide behind its own regulations to prevent disclosure of public information about investigational treatments.
This past week, the Goldwater Institute filed another FOIA request with the FDA, this time seeking information about the CTAP program and any authorizations or denials made by the FDA under that program.
Openness and transparency should guide any government process, especially when lives are at risk. The FDA should be applauded for speeding the clinical evaluation process and facilitating patient access to these investigational treatments. In fact, presumptive access should be the rule and not the exception if and when patients, their physicians, and the manufacturers choose to do so. But we all have a right to know how the FDA makes these life-and-death decisions.
Naomi Lopez is Director of Healthcare Policy at the Goldwater Institute. Jon Riches is the Director of National Litigation at the Goldwater Institute. Riches is also lead attorney in Goldwater Institute v. U.S. Health and Human Services.