FDA pressure intensifies over cyber attack
pharmafile | December 18, 2013 | News story | Medical Communications, Research and Development, Sales and Marketing | FDA, PhRMA, cber, digital, leak
The FDA is facing mounting pressure from a US government committee into how it allowed several of its databases to be hacked during the government shutdown in October.
Senior Republican members of the House Energy and Commerce Committee have opened an investigation into the hacking of several databases maintained by the FDA’s Center for Biologics Evaluation and Research (CBER), saying information provided to the public indicates that its databases may not have been properly secured.
This comes a week after 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 hacking into the FDA’s system occurred in October – but the FDA did not make the attack public, and instead issued a statement to members of industry that databases within the CBER had been hacked. The story did not come to light in the media until mid-November.
It is now known that the hacking happened on 15 October, when the agency was in the middle of an enforced government shutdown with thousands of employees furloughed. The regulator re-opened several days later when the government agreed a new deal to pay their staff.
The affected databases included the Biologic Product Deviation Reporting System, the Electronic Blood Establishment Registration System, and the Human Cell and Tissue Establishment Registration System.
The FDA said it was aware that user names, their information, phone numbers, email addresses and passwords had all been accessed. In all, 14,000 accounts both were believed to be accessed.
The FDA has since taken steps to disable the systems, implement new security measures and reset passwords for around 5,000 of the active user accounts.
It has also advised users to reset account information, and said they should monitor their credit reports for possible identify theft as well, according to a statement.
In their letter to the FDA, the Energy and Commerce Committee members said that the attackers had breached the FDA’s online gateway system, compromising confidential business information along with sensitive data about patients enrolled in clinical trials.
But FDA spokeswoman Jennifer Rodriguez told Reuters that this was wrong: “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.
“This system is not used to submit any applications. It is not the electronic gateway that was breached,” she added.
Rodriguez also said that the agency was not aware of any attempts to use stolen information for ‘criminal or other inappropriate purposes.’
Pharma presses for audit
Sascha Haverfield, VP of the US lobby group PhRMA, said in a statement. “It is the legal obligation of the Food and Drug Administration to protect companies’ trade secrets and confidential commercial information.”
PhRMA said on Tuesday that it supported the committee’s request for an independent audit.
Any sort of breach will cause consternation with pharma – who pay fees to the FDA – as they provide the regulator with highly sensitive data that would be priceless to a competitor.
It is not yet known who was responsible for the hacking.
Ben Adams
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