Goldwater Sues Government for Information on Drug Approval Process

August 11, 2020

The federal government has long carried on a behind-closed-doors process for granting patients special access to lifesaving medications that have not yet been approved for use. Together with attorneys from the law firm Frier Levitt, the Goldwater Institute is taking a stand and filing a lawsuit against the U.S. Food and Drug Administration (FDA), demanding that it make this information public. 

The FDA is responsible for approving drugs for the public’s use, and through its expanded access program, some patients gain access to investigational medications that do not yet have final FDA authorization. In light of the ongoing COVID-19 pandemic, and because many coronavirus patients are receiving medications through this program, public access to this information is more important than ever—yet the FDA has repeatedly ignored the Goldwater Institute’s attempt to gain public information about the program.

Four years ago, the Goldwater Institute requested records from the FDA under the Freedom of Information Act (FOIA), the federal law which requires the government to disclose information and documents to the public. Despite the Institute’s numerous letters, administrative appeals, and other attempts to work with the agency, the FDA has delayed making this information public, in plain violation of the law. Now, with this lawsuit filed today in the U.S. District Court for the District of Columbia, the Goldwater Institute seeks to compel the FDA to comply with the law and allow the public to see this vital information.

The Goldwater Institute is represented by Nicole DeWitt and Jonathan Levitt of the law firm Frier Levitt. Ms. Dewitt and Mr. Levitt are part of the Institute’s American Freedom Network—a nationwide network of pro bono attorneys providing crucial legal support on matters that advance individual liberty and constitutional government, including government transparency and accountability actions.  

“The public has a right to know how lifesaving drugs are made available in this country, especially during a pandemic,” Ms. DeWitt said. “Despite numerous attempts to work with the FDA, the FDA has delayed and stonewalled the public’s access to this information for far longer than the law allows.”

“We are enormously grateful for the dedication and diligence of AFN attorneys like Jonathan and Nicole,” said Jon Riches, Director of National Litigation at the Goldwater Institute. “Through our pro bono program and through important cases like this, AFN is ensuring that the public is properly informed and retains the right to know what our government is up to.”

This is not the first time that the Goldwater Institute has led an effort to shine a light on FDA actions. In March 2020, Goldwater won a major victory against the FDA in a similar case in which it sought information about how federal officials decided to make a lifesaving drug available during the Ebola outbreak in West Africa several years ago. In that case, the Ninth Circuit ruled in favor of the Goldwater Institute’s FOIA of the FDA, finding that the agency’s internal regulations did not trump the transparency requirements of the federal law.