Lawmakers have asked the Food and Drug Administration (FDA) to look into an October hack that involved an unauthorized user gaining access to the agency's online submission systems.
In a letter to FDA commissioner Margaret A. Hamburg, five representatives on the Energy and Commerce Committee, expressed concern over the incident that didn't gain much media exposure. The Energy and Commerce Committee is longest standing legislative committee in the U.S. House of Representatives.
According to the letter, the breach occurred on Oct. 15 when an unauthorized user gained access to the electronic submission system, which hosts information on all medical product information for the FDA, “including information for drug and medical device products.” Members of the industry were not notified of the incident until Nov. 8.
In addition to “confidential business information,” the sensitive medical data belonging to patients enrolled in clinical trials was also accessed, as well as names, phone numbers, email addresses, and passwords to 14,000 accounts, of which close to 5,000 are active.
The legislators that penned the letter, which include Reps. Fred Upton, R-Mich., Tim Murphy, R-Pa., Joe Barton, R-Texas, Marsha Blackburn, R-Tenn., and Michael Burgess, R-Texas, have asked the agency to hire experts to conduct an investigation into the breach.
“It is essential to the fulfillment of FDA's mission that regulated industry and patients have confidence in the security of sensitive information they submit to the FDA,” they wrote.
The FDA allocates 12 percent of its budget toward information technology, which the legislators believe should be preventing breaches. They have asked the agency to respond to their requests by Dec. 19.