FDA Policy/General

Grassley Wants HHS Cyber Test Responses

Senate Finance Committee chairman Charles Grassley (R-IA) is asking HHS secretary Alex Azar for information on the department’s efforts to implement recommendations from the HHS Inspector General (OIG) to improve cybersecurity in eight HHS agencies including FDA. In a 4/9 letter, Grassley says the OIG recommendations included use of standard security requirements, requiring contractors to comply with appropriate security standards, and improving continuous monitoring procedures. The recommendations were in an OIG 3/1 report outlining the results of penetration testing of the eight agencies.

“The tests probed and analyzed the cyber posture and vulnerability from outside of the HHS operating division’s network security perimeter,” the letter says. “…While the HCC Office of Information Security concurred with the recommendations, I would like clarification on what HHS has done to achieve these objectives.”

The letter specifically asks:

which HHS departments were notified via early alerts about the OIG’s findings;
whether HHS has implemented any agency-wide cyber policies to address concerns raised in the OIG report, with information on what the policies are and when they were implemented;
a written summary on how HHS has implemented fixes sufficient to close the recommendations; and a timeline outlining implementation of the recommended policies and anticipated dates of compliance.

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