FDA Sued for Not Disclosing More Info on the Experts Determining the Fate of Drugs and Devices
April 29, 2016
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – A consumer group, the Public Citizen Foundation, Inc., filed a lawsuit against the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services to force the agencies to disclose more information about the people on advisory committees who determine the fate of potential drugs and medical devices.
In its filing, the Public Citizens Foundation said it wants the FDA and HHS to produce unredacted copies of resumes of the members of the advisory committees. The PCF called the practice of redacting professional backgrounds of the advisory committee members is “unlawful.” The organization said that a large percentage of all resumes posted on the FDA’s website for the approximately 50 advisory committees contain “improper redactions.” In its filing, the foundation said as of April 6, 2016, there are 150 resumes posted on the website for the Center for Drug Evaluation and Research advisory committees, with 138 having been redacted. Additionally, the group said of the 57 resumes posted for members of Center for Biologics Evaluation and Research advisory committees, 49 have been redacted. All of the CVs posted for members of the Tobacco Products Scientific Advisory Committee and the Pediatric Advisory Committee have redactions, the foundation said in its filing.
The foundation said information that is redacted from the posted resumes include “dates of degrees conferred, the names of professional colleagues and mentors, the amounts of grants received from private companies, and the names of presentations and unpublished articles.” As an example, the foundation cited its own Michael Carome, an advisory committee member and director of Public Citizen’s Health Research Group, who said the resume he gave the FDA included redactions of his military awards and services, as well as the amount of a grant he received from the National Kidney Foundation.
The concern is that members of the advisory committees may have conflicts of interests when they are offering advice to the FDA on whether or not a drug should be approved. The FDA is not compelled to follow the recommendation of the advisory committees, but often does.
Rachel Clattenburg, an attorney representing Public Citizen Foundation, said the redaction of information is unnecessary and shows the “FDA has wasted considerable time going through (resumes) to black out information.”
“We worry that the FDA’s treatment of advisory committee member (resumes) is an indication that the agency favors secrecy over disclosure,” Clattenburg said in a statement.
According to the filing, the foundation reached out to the FDA on several occasions over the past two years seeking to end the practice of having the information be redacted, saying that by nature, resumes are intended to be shared. The filing said Sarah Kotler, deputy director of the FDA’s Division of Freedom of Information, responded to the group’s concerns in 2014 saying the FDA would “not be revising our web pages so that all of the CVs (curriculum vitae) of advisory committee members are posted without redaction.”
In its 45 years of operation, Public Citizens has clashed with the FDA over concerns about approved drugs and drug pricing. In 2005, the group lost a petition to have the FDA remove AstraZeneca ’s Crestor from market. This week the foundation condemned Gilead Sciences for the high prices it charges for its blockbuster hepatitis C treatments.
“Thanks to Gilead’s price gouging, life-saving hepatitis C cures are being rationed. Too many Americans, including veterans and low-income workers struggling to make ends meet, have been denied access to a hepatitis C cure,” the foundation said in a statement.