FDA Policy/General

FDA Security Checks Concern Agency Scientists

A new policy on security background checks is raising confusion and alarm for some FDA scientists, according to an online Science post. The article says the change was included in a “communications plan” that went to agency senior staff in recent weeks. Science says the plan “appears to effectively bar the agency from hiring, whether as employees or contractors, foreign nationals who have not lived in the U.S. for a total of three out of the last five years.”

The post says the agency asserts the new requirement is based on recent revisions to government-wide security policy, “but it appears to be interpreting those rules more strictly than some other agencies.” The change would apply to new hires starting work after 10/1 and not to current staff. FDA estimates it would affect about 50 people a year, most of them postdoctoral fellows in short-term positions.

“This is a real sea change in how we function,” an FDA scientist who requested anonymity told the magazine. “We can kind of look around and name people who are now in serious leadership positions in FDA who would never have gotten in the door under this rule.”

The change involves rules for receiving standardized government identity cards that enable access to agency facilities, data, and computer systems. While some other agencies (including HHS and the National Institutes of Health) say they will continue to use an alternative approach allowing them to issue identity cards until a staffer has been in this country for three years and can undergo a standard background check, FDA is choosing not to make that alternative available, Science says.

The post says an agency spokesperson acknowledged the discrepancy and said that FDA’s primary responsibility in working with companies to regulate drug and food safety imposes special requirements. “We differ from the other HHS operating divisions in that we’re in possession of trade secrets and confidential commercial information and data that’s valued in the billions of dollars,” the spokesperson reportedly said. “So it’s our view that we need to follow both the letter and the intent of the new policy.”

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