A Food and Drug Administration (FDA) official provided detail about the agency's IT strategy that aims to strengthen protection of pharmaceutical companies' data submitted in regulatory filings during the approval process of new drugs.
Wintermute said at an industry event in Washington, D.C. on Friday, according to a FedScoop report. “They want to get that data for not just a trophy; they want to actually be able to use it for some kind of competitive advantage.” More than 90 percent of regulatory information submitted to the FDA is sent electronically, he said.
The Information Technology Strategic Plan aims to roll out verification and validation for high‐risk systems, next‐generation network security architecture, and improve the agency's patch management plan. The plan, released in September 2015, uses a scorecard approach, similar to the approach in the FDA's proposed medical device guidelines released in January.
A report published in April noted an increase in cyber incidents targeting the manufacturing sector, including pharmaceutical companies, attributed to an increase in attacks seeking intellectual property. Another report published in October found that two pharmaceutical companies may have been among the companies targeted by hackers connected to the Chinese government less than a month after the U.S. and China agreed not to engage in cyber-theft of corporate intellectual property.