FDA reveals security breach affecting confidential pharma documents

The US Food and Drug Administration has revealed a cyber attack has gained access to one of its online systems used for companies’ sensitive and confidential information.

The system, involved in the evaluation of biologicals but not, according to an FDA spokesperson, used for submissions, “maintains account information” for pharmaceutical companies.

Representatives of the Biotech industry are not reassured, however, and a committee of the US House of Representatives has demanded an independent audit from Margaret Hamburg, head of the FDA.

“It is the legal obligation of the Food and Drug Administration to protect companies’ trade secrets and confidential commercial information.”

Sascha Haverfield, vice-president, PhRMA

This is not the first time the FDA has come under scrutiny over confidentiality – the regulator in 2012 investigated a document management company it used after a reported 75,000 pages of confidential medical devices information were “inadvertently released”.


Related news:

Drugmakers urge FDA security audit after cyber breach (Reuters).

Reference links:

FDA investigates how confidential files went missing (Nextgov, July 2012).

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