FDA Policy/General

Agency RIF Packets Cause Privacy Concerns

Some FDA employees who received reduction-in-force (RIF) informational packets were given sensitive information about other employees as well as information about themselves. FedScoop reports it spoke to two agency employees who were affected by the RIF and said they knew of instances when fired workers received personally identifiable information for other people, including Social Security numbers.

As one person told the newsletter, the information was “everything needed for successful identity theft.”

There are also indications, FedScoop says, that the latest RIF information was sent in typical manila envelopes sealed only with the metal clasp on the back of the envelope. In some cases, the workers said, other employees’ envelopes had been ripped or they didn’t receive one.

The National Treasury Employees Union chapter that represents FDA workers in five states and Washington, DC, said the union told members it “has been made aware of troubling reports that some RIFd employees received sensitive documents through unsecured mail sent by FDA. These documents contained private and personally identifiable information, including Social Security numbers, without adequate safeguards. This negligent handling of your information may constitute a violation of the Privacy Act.”

Union officials told the newsletter they would like to discuss the issue with FDA, but the agency has been ignoring the union under President Donald Trump’s executive order purporting to apply national security exclusions to unions at some federal agencies. FDA did not respond to FedScoop’s request for comment.

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