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Commish says FDA needs to oversee compounders but spars with House over how

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The investigative hearing a U.S. House committee held Wednesday on federal oversight of compounders may have been mostly a finger-pointing exercise but House members and FDA Commissioner Margaret Hamburg seemed to agree that the FDA will soon take responsibility for at least some compounders. House members said the FDA should have already stepped up and Hamburg said the agency is ready to but just needs the clear legislative authority to.

"There is an enormous lack of clarity, and we should seize this opportunity to address it," The New York Times reports Hamburg saying during the hearing. Rep. Cliff Stearns, who chairs the Republican-controlled House Subcommittee on Oversight and Investigations, had a different take, saying the question is whether the FDA might have prevented the fungal meningitis outbreak tied to a steroid produced by large-scale compounding pharmacy New England Compounding Center.  He answered himself with, "The answer appears to be yes."

Meanwhile Barry Cadden, an owner and the chief pharmacist at NECC, didn't have anything to say about the outbreak tied to his company that has now claimed 32 lives of the 461 who have been infected. He invoked his Fifth Amendment right to remain silent in response to every question, The New York Times reports.

Compounders are traditionally overseen by state agencies, but this situation is complicated by the fact that the FDA has been in the NECC plant before and raised questions about sterility at the facility. In 2006, FDA investigators wrote up a warning letter on the company after checking on a complaint that it was inappropriately repackaging Roche's ($RHHBY) cancer drug Avastin. There was also a visit in 2002.

Defenders of the agency point out that when it tried to exert greater authority 10 years ago, its efforts were turned back by litigation and a Supreme Court ruling that muddied its authority. And today the International Academy of Compounding Pharmacists was prepared to tell a U.S. Senate oversight panel today that enough regulatory authority already exists and said states should continue to oversee its members, Reuters reports.

House members earlier this year were critical of how Hamburg was running the agency but that time took the opposite view than is it is taking in this case. In a report in June, a House subcommittee said the FDA under Hamburg has been too aggressive in its inspections of drugmakers, leading to plant closures that then resulted in shortages of critical drugs. In that case, the agency responded that its actions were needed to protect consumers from unsafe medications.

Either way, the hearing Wednesday and another in the Senate slated for today are likely to lead to some kind of legislation, or position, in which the FDA will take on some oversight over so-called nontraditional compounders like NECC that operate more like small-scale drug manufacturers. These are the ones that produce products on a larger scale, not just mix up specialized drugs for local doctors, and then ship their drugs around the country.

- read The New York Times story
- get more from the Financial Times 
- see still more from Reuters

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