FDA Policy/General

FDA Cybersecurity Incidents Counted

FDA reported 1,036 cybersecurity incidents between 1/2013 and 6/2015, according to a Federal Times report based on information obtained through a Freedom of Information Act request. Some 50% of the incidents were attributed to unauthorized access, while 21% were scans, probes, or attempted access, and 19% were malicious code discovered on FDA systems.

The article says that while the threat vectors track closely to what is happening at most HHS agencies, the likely reasons behind the hacks are unique to FDA.

“There has been a huge amount of hacking in the pharmaceutical world,” says DRI International president Al Berman in the article. “One of the reasons this is being done is for stock manipulation. If you can find out where somebody is in the testing phase for a drug … if you can figure out where they are in the cycle or how well it’s going, I think that’s tremendous information, with different reasons than any other hack you’ve seen.”

Information security officials at HHS agencies are very aware of the sensitivity of the data they protect, according to HHS cybersecurity official Leo Scanlon. He told Federal Times that the department uses threat data to build a profile of how agencies such as FDA are being attacked and then develop a response in kind.

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