The pharmaceutical industry is urging the FDA to undergo an independent security audit after hackers broke into an online system used by drug companies to submit information to the FDA this past October.
FDA spokeswoman Jennifer Rodriguez maintains that the breached system was not the FDA's "gateway system," which contains confidential business information, along with sensitive patient data regarding clinical trials.
Pharma trade groups, including PhRMA and BIO, as well as lawmakers, are not convinced, and are asking the FDA to launch a third-party audit that would "assess and ensure the adequacy of FDA's corrective actions" following the breach.
