Regulatory Focus™ > News Articles > In Wake of Meningitis Outbreak, Senator Calls for New FDA Authority to Regulate

In Wake of Meningitis Outbreak, Senator Calls for New FDA Authority to Regulate

Posted 08 October 2012 | By Alexander Gaffney, RAC 

In the wake of a widespread outbreak of meningitis, at least one US senator is calling for new authority to be given to the US Food and Drug Administration (FDA) to make its authority to oversee compounding pharmacies clearer and more robust.

In remarks reported by CBS New York, Sen. Richard Blumenthal (D-CT) said he remained concerned that FDA did not have sufficient authority to investigate compounders.

"We need to bolster the authority of the FDA and make sure it uses its existing authority more strenuously and stringently to stop the contamination of products at these compounding pharmacies by stronger oversight, inspection, regulation if necessary," Blumenthal said.

The New England Compounding Center (NECC) is reportedly the source of a burgeoning meningitis outbreak that has sickened dozens and killed at least seven people who were injected with a steroid manufactured at NECC's Massachusetts-based facility. The firm was previously the recipient of a warning letter from FDA in 2006 alleging the company manufactured unapproved pharmaceutical products.

The 2006 letter highlights many of the same issues now under the scrutiny of Blumenthal and other industry observers. For instance, FDA goes to unusual lengths to establish its jurisdiction over NECC, noting its historical use of enforcement discretion to not take action against compounding pharmacies. The letter also mentions that FDA's inspection was conducted alongside the Massachusetts Board of Pharmacy-a rarity not often seen in FDA's warning letters.

While Blumenthal didn't mention the previous warnings against NECC in his remarks-or the company's subsequent consent decree-he noted that, "This incident ought to be a clear alarm, a wake-up call that compounding pharmacies pose a potentially dangerous, even deadly source of disease if they are not properly regulated."

The "regulatory black hole" in which compounding pharmacies exist ought to be closed, added Blumenthal, formerly Connecticut's attorney general and now a member of the Senate's powerful Committee on the Judiciary.

The debate about exactly how those regulatory loopholes should be closed-or if they should-is likely to be kept on hold until after the presidential election. Congress is currently out of formal session until 12 November 2012, at which time it will be preoccupied with addressing a number of substantial issues. Chief among those issues is likely to be a series of massive budget cuts known as budget sequestration set to come into effect on 2 January 2012.


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