By Alicia Mundy
As Food and Drug Administration officials examine internal controls in the wake of insider-trading charges filed against a longtime employee, a primary challenge will be how to limit access to valuable information without clogging up the approval process.
The computer database that chemist Cheng Yi Liang is accused of exploiting to make illegal stock-market gains is credited, for example, with preventing contradictory decisions on drug approvals by different parts of the FDA.
The Document Archiving, Reporting and Regulatory Tracking System, or Darrts, was created several years ago for the FDA’s Center for Drug Evaluation and Research, where Mr. Liang worked. It tracks all actions on pending approvals, including agency reviews of the safety and efficacy that can impact final approval decisions. Mr. Liang was authorized to use the system.