Report: Monitoring Scandal Involves Top FDA Officials

Top officials in the US Food and Drug Administration (FDA) were personally involved in reviewing and approving a surveillance program which targeted group of whistleblowers within the agency, reports The Wall Street Journal.

The Journal's 7 August report highlights for the first time the involvement of FDA Commissioner Margaret Hamburg, the top official at the US regulatory agency, who was reportedly briefed on the surveillance program shortly after the initiation of the investigation. (For background, please see Regulatory Focus' 16 July 2012 article, "Investigation into FDA Reveals 'Enemies List,' Extensive Monitoring Practices.")

The report also provides further insight on the start of the investigation, which was triggered after several companies complained that proprietary information about their products had been leaked to media organizations and subsequently appeared in articles.

Shortly after the concerns were brought to FDA, Jeffery Shuren, director of FDA's Center for Devices and Radiological Health (CDRH), instructed Associate Director for Management Ruth McKee to assess available options to plug the leaks of information. McKee would reportedly meet with Lori David, then chief information officer of FDA, who recommended the use of monitoring.

Also briefed on the investigation was Ralph Tyler, then the general counsel of FDA. The agency's current chief counsel, John Taylor III, has reportedly been looking into the matters himself.

The proximity of FDA's top leadership ranks to the burgeoning scandal could lead to more than just cosmetic problems, remarked former FDA Commissioner David Kessler to The Journal. "This is where administrators get tested if they're not well-schooled in whistleblower law," he remarked.

The legal issues, paired with attention from political figures including Sen. Charles Grassley, could threaten to entangle senior level FDA officials at a time when the US election season is gaining momentum.

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