FDA sued over redacting its experts’ job history

FDA sign

Public Citizen has issued a lawsuit against the FDA in an attempt to force it to come clean on the employment history of the regulator’s advisory committee members who help to assess new drug approvals.

The Washington, D.C. consumer rights group Public Citizen has filed the Freedom of Information Act (FOIA) after it discovered that the agency redacted copies of the CVs from its expert advisors.

The FDA has around 50 advisory committees composed of outside experts who advise the agency on issues such as whether the FDA should approve new medical products or change a product’s labeling.

The FDA frequently (although they are not obliged to) follows the recommendations of its advisory committees, but Public Citizen has taken exception to the fact that the FDA redacts information from most of the advisory committee members’ CVs posted on its website.

It said that the FDA blacks out information in the CVs about the 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colleagues and mentors; the amounts of grants received from private companies; and the names of presentations and unpublished articles.

“Redactions of such information deny the public access to information that may bear on the qualifications, backgrounds and potential biases of advisory committee members,” Public Citizen said in a statement.

Dr. Michael Carome, an advisory committee member and director of Public Citizen’s Health Research Group, told the FDA when he provided his job history that the CV could be made public without any redactions. Yet when the FDA posted it online, the agency redacted it anyway.

“The agency redacted my military awards and service and the amount of one National Kidney Foundation grant long since closed out,” explained Carome. “The notion that releasing this information would be an invasion of privacy or that it was confidential would be hard to understand anyway--but after I specifically had stated that the CV could be posted in full, it is ridiculous.”

Believing the redactions to be unjustified, Public Citizen said it is also seeking an order requiring the FDA to post unredacted copies of the CVs on its website going forward, because FOIA requires agencies to post frequently requested records online and the FDA’s website states that advisory committee members’ CVs are frequently requested.

The FDA has said that these redactions protect confidential and private information.

“Confidential information does not appear on documents crafted for the express purpose of sharing with other people,” said Rachel Clattenburg, the lead Public Citizen attorney on the case.

“The redactions are unjustified and show that the FDA has wasted considerable time going through CVs to black out information. We worry that the FDA’s treatment of advisory committee member CVs is an indication that the agency favors secrecy over disclosure.”

The consumer group has also taken exception to the pharma industry this year, releasing a report in March in which it said that stronger enforcement is needed to deter pharma manufacturers from “continuing to break the law and defraud federal and state health programs.”

It even gained a quote from Sen. Bernie Sanders (I-Vt.), who said: “Time and time again, drug companies defraud American taxpayers while making billions off government-granted monopolies.

“Enough is enough. The greed of the pharmaceutical industry must end. I urge my colleagues to stand up to the pharmaceutical industry and pass legislation to send a clear message that crime will no longer pay.”

- check out the FOIA