FDA Policy/General

Public Citizen Suing FDA for Committee Member Info

Public Citizen has filed a Freedom of Information Act suit against FDA asking that the agency post unredacted copies of the curricula vitae (CVs) of advisory committee members on its Web site. A news release from the advocacy group says that despite the fact that the CVs are created for the specific purpose of being shared, FDA redacts information from most of the advisory committee members’ CVs posted on the agency Web site.

“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colleagues and mentors, the amounts of grants received from private companies, and the names of presentations and unpublished articles,” Public Citizen says. “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 says that in addition to suing to receive unredacted copies of the CVs, it also wants an order requiring FDA to post unredacted copies on its Web site going forward, because the Freedom of Information Act requires agencies to post frequently requested records online and the FDA Web site concedes that advisory committee members’ CVs are frequently requested.

The agency has claimed that the redactions protect confidential and private information, Public Citizen says. It counters, however, that CVs are compiled by individuals specifically for the purpose of touting their backgrounds and accomplishments, and each person chooses what information to include and how to state it on the CV.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome