The breach occurred in an area used where submission of data to the FDA is concerned.  Drug companies for obvious reasons want to ensure that nothing was breached beyond names and passwords and last month the FDA did send a notice out to all describing what was accessed in the breach which appears toimage be limited; however if they got into portions of the servers, time to look at the whole system of course to audit and make sure proper best practices are being followed and see if any other potential weak areas of security exist.

The FDA was quick to dispute rumors that clinical trial data had been accessed.  The House of Representatives has issued their request for an audit.  You know at times like this having the Office of Technology Assessment for Congress would be a real help as they could dig down deep right away and assess the nature of breaches and other technology related issues as now we have to wait and see.  Private industry though when issues like this arise might be the fuel needed to convince Congress they need better tools to help them do their job.  BD

Congress Needs a Bigger Brain–Restore the Office of Technology Assessment And Truly Assess What is Useful And Remove The Algo Duping Permeating In Government–Fantasy Perceptions That Are Not Real Can Be A Dangerous Thing

(Reuters) - The U.S. Food and Drug Administration is under pressure from the pharmaceutical industry and lawmakers to undergo an independent security audit, after hackers broke into a computer system used by healthcare companies to submit information to the agency.

Drug companies fear the cyber thieves may have accessed corporate secrets that are on file with the agency, such as data about drug manufacturing, clinical trials, marketing plans and other proprietary information.

While some lawmakers charge that the hackers breached the FDA's gateway, compromising confidential business data, the agency argues that the access was limited.

The U.S. House of Representatives Energy and Commerce Committee launched an investigation, and last week four senior Republican members of that committee sent a letter to FDA Commissioner Margaret Hamburg asking her to immediately launch a third-party audit that would "assess and ensure the adequacy of FDA's corrective actions" following the breach.

"The system that was attacked maintains account information for the Biologic Product Deviation Reporting System, the Electronic Blood Establishment Registration System and the Human Cell and Tissue Establishment Registration System," she said.


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