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The Public Has a Right to Know How Government Makes Drug Approval Decisions

March 24, 2020

March 24, 2020
By Jon Riches

Lately, there’s been a good deal of discussion about how the government can speed the availability of treatments in the middle of an outbreak. But shouldn’t the public be able to know how the government makes those decisions?

Well, the COVID-19 epidemic certainly isn’t the first time this question has been relevant. And a Ninth Circuit Court of Appeals decision issued today may have major ramifications for how it’s answered.

Jon Riches is the Director of National Litigation at the Goldwater Institute.

In a timely decision for government transparency in healthcare, the Ninth Circuit today ruled in favor of the Goldwater Institute in a Freedom of Information Act (FOIA) case seeking information about how federal officials decided to make a lifesaving drug available during the Ebola outbreak in West Africa years ago. 

In 2014, the Institute filed a FOIA request in an effort to understand the U.S. Food and Drug Administration’s (FDA) decision to let two American doctors infected with Ebola use the drug ZMapp, which was then still in the very early stages of development. But although we sought no information about the drug itself, the FDA denied our request, maintaining that the FDA’s own regulations prevented it from releasing any records included in an investigational new drug (IND) application because the entire file was the drug company’s “private commercial information.” But of course, we weren’t seeking any information about the activities of private parties—just about government functions; specifically, how the approval process worked in this case, and whether the FDA’s own rules and processes were followed. 

Nevertheless, the FDA stonewalled for years, even arguing that its internal regulations trumped the requirements of federal law. 

On Tuesday, the Ninth Circuit said no. Federal bureaucrats cannot “rely on [their] regulations governing the confidentiality of IND files to withhold the entire ZMapp file,” it declared. Allowing the FDA to bar the disclosure of the IND file “in toto” would mean that the agency could basically rewrite federal transparency requirements at will.

At a time when Americans are focusing more than ever on how the FDA’s authority over medicine and healthcare needs clarity and flexibility, this decision is a victory of major importance. The drug approval process in the United States should not be a government secret, particularly during the present coronavirus outbreak. The FDA should be applauded for making vitally needed medicines more available, especially in times of crisis. But it should be open about how it makes those decisions so that we can know how to improve medical regulation to increase innovation and availability and prevent future catastrophes.

Jon Riches is the Director of National Litigation at the Goldwater Institute.



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