Public Citizen Sues FDA Over Redacted Advisory Committee Info

The consumer group Public Citizen defense continues the Food and Drug Administration (FDA) in federal court in the practice of the agency that the information is correct in the curriculum vitae (CV) of the members of the Advisory Committee.

Public Citizen claims that the editors of withholding information about these external experts who could reveal the potential bias and provide relevant background in their professional qualification, according to a lawsuit filed in the US District Court for the District of Columbia on Wednesday.

The complaint:

In its complaint, Public Citizen calls the practice of the FDA to write the CV "arbitrary and capricious" and said that the body does not disclose proactively documents under the Freedom of Information Act (FOIA).

Specifically, the group believes that the reasoning of the FDA to draft a request does not meet the criteria of one of the nine exemptions of the FOIA that information is correct.

According to Public Citizen, about 90% of the CV on the website of the FDA for the members of the Advisory Committee contains essays (Center for Drug Evaluation and Research Drug, 92%; Center for Drug Evaluation and Biologics Research, 86 %, Center for devices and radiological health, 98%).

Public Citizen said first raised the issue of the FDA in a letter dated February 4, 2014 Public Citizen, said Sarah Kotler, who was deputy director of the FDA for Freedom of the Information Division, responded by saying the FDA policy is " categorically clean up "some information in the CV of members of advisory committees.

Editorial Advisory Committee:

FDA maintains about 50 advisory committees composed of experts from outside the weighing on scientific and medical issues specific agency. The agency generally meets Advisory Committee meeting when he wants to enter a new drug or device, or when looking at a specific safety issue for an approved product.

Although the FDA publishes the CV of members of advisory committees on its website, often writes information, such as "new degrees of dates, names of colleagues and mentors, the amount of subsidies received from private companies, and the names of the presentations and unpublished articles. "

According to Dr. Michael carome, director of Group Health Research Public Citizen, part of the Advisory Committee of the FDA pharmacy body composition he wrote his CV despite his request to be made available without redaction.

"The agency awards and written my military service and the amount of a grant from the National Kidney Foundation of long liquidation," he said. "The idea that the disclosure of this information would be an invasion of privacy or that it was confidential would be difficult to understand anyway - but after I had expressly indicated that the CV can be seen in its entirety, is ridiculous."