By Nate Raymond
LAS VEGAS, March 11 (Reuters) - The U.S. Food and Drug Administration plans to intensify its focus on whether companies are adhering to good manufacturing practices in the wake of a meningitis outbreak last year linked to a Massachusetts compounding pharmacy, the agency's criminal investigative chief said.
John Roth, director of the FDA's Office of Criminal Investigations, said officials are seeking to ensure that companies are appropriately balancing their profit motives with the need to manufacture food and drugs responsibly.
The meningitis outbreak and other recent cases have spurred the agency to take a closer look at this balance, Roth told lawyers at an American Bar Association-sponsored conference in Las Vegas focused on white-collar crime.
"We wonder exactly if this is a systemic problem, if it requires a broader response by the FDA or is it an anomaly," Roth said in a panel discussion Friday. "We're going to be taking a look at that and hopefully we'll launch in a thoughtful way."
The New England Compounding Center in Framingham, Massachusetts filed for bankruptcy last year after authorities said more than 14,000 people were exposed to fungus-tainted vials of steroids typically used to treat back pain. The outbreak led to dozens of deaths, according to the U.S. Centers for Disease Control and Prevention.
Compounding companies such as NECC have been mostly regulated by state authorities rather than the FDA. Since the meningitis outbreak, the FDA has been seeking a greater role in regulating large-scale compounders.
Joseph Savage, a white-collar defense lawyer at Goodwin Procter speaking on the same panel, said that companies can face heavy repercussions for poor manufacturing practices.
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