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Subject: [ISN] Drugmakers and legislators want an outside audit of the FDA's hacking incident
From: InfoSec News <alerts () infosecnews ! org>
Date: 2013-12-19 8:49:18
Message-ID: alpine.DEB.2.02.1312190849050.23000 () infosecnews ! org
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http://www.fiercepharma.com/story/drugmakers-want-outside-audit-fdas-hacking-incident/2013-12-18#ixzz2nuNgZ0UQ
By Eric Palmer
FiercePharma
December 18, 2013
Hackers got into FDA computer systems recently, prompting the agency to warn
drugmakers to be on the lookout for misuse of their credit and to change their
passwords. But some drugmakers fear the breach will also put their trade
secrets--clinical trial data and manufacturing processes--at risk.
Trade associations and some legislators are now urging the FDA to let outside
professionals analyze the attack and determine for sure what was taken, Reuters
reports. In a letter to FDA Commissioner Margaret Hamburg, 5 members of
Congress asked her to have an audit performed to "assess and ensure the
adequacy of FDA's corrective actions."
The letter says the FDA notification to drugmakers suggests data were not
encrypted. It also claims hackers had wormed their way into the "FDA's gateway
system," allowing them access to confidential business information and
sensitive data on trial participants. The FDA says that just isn't so. FDA
spokeswoman Jennifer Rodriguez told Reuters the system that was attacked
maintains account information for the Biological Product Deviation Reporting
System, the Electronic Blood Establishment Registration System and the Human
Cell and Tissue Establishment Registration System. "This system is not used to
submit any applications. It is not the electronic gateway that was breached."
[...]
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