FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Goldwater Institute Sues FDA

June 17, 2015

The Goldwater Institute is suing the FDA after it denied the group’s Freedom of Information Act request for information on the process the agency used in allowing two Americans to be treated with an investigational anti-Ebola drug.

In October 2014, Goldwater filed the FOIA request to see if the two patients had gotten Mapp Pharmaceuticals’ Zmapp — which is still under review — through the FDA’s compassionate use program, which gives small numbers of patients access to experimental drugs outside a clinical trial.

The FDA denied the request, citing commercial confidentiality laws that prevent it from confirming if a company has filed an investigational new drug application needed to start a clinical trial.

The institute also wants to know if the two patients, and any others, were required to comply with the standard compassionate use process, which other Americans seeking access to experimental drugs must follow. “Americans have a right to know how their government approves new drugs for use and under what circumstances exceptions to that process are allowed,” says Jon Riches, a Goldwater attorney.

The FDA is not required to disclose information on compassionate use, which requires the drugmakers’ permission to use an investigational treatment. Physicians who submit such requests on behalf of patients also are supposed to get the FDA’s blessing, but companies aren’t legally required to report all requests to the agency.

The Goldwater Institute is behind an effort to get states to adopt “Right to Try” laws, which grant terminally ill patients access to drugs that have been approved by the FDA for clinical trials but may be years away from hitting the market. If the compassionate use process was circumvented, or even accelerated for the two Ebola victims, other sick or dying Americans should have access to that information so that they, too, can get potentially life-saving care, the group says.

An FDA spokeswoman said the agency does not comment on possible, pending or ongoing litigation or on the development of specific medical products.
Goldwater Institute v. FDA was filed in U.S. district court in Arizona. View the complaint at www.fdanews.com/06-11-15-lawsuit.pdf. — Kellen Owings