FDA's role in meningitis outbreak examined
By law, compounding pharmacies like the New England Compounding Center, which sold the tainted steroid injections behind the outbreak, are regulated primarily by states. Despite having information in 2002 that NECC might be unsafe, the FDA could do little when the center's chief pharmacist refused to cooperate with inspectors, according to Richmond.LegalExaminer.com.
The pharmacist, Barry Cadden, was cooperative when inspectors first arrived, but the next day he challenged their legal authority to be at the pharmacy. Unclear legal boundaries complicated the FDA's response when Cadden later refused to provide records and NECC continued to ship its products despite the agency's concern.
The FDA had the right to seize an adulterated NECC product in 2002, but officials said that such an action would not resolve the company's poor practices. Agency officials then left authority in the hands of Massachusetts state regulators, reportedly believing they were in a better position to gain NECC's compliance or to take regulatory action, according to the New York Times.
In response to the outbreak, the FDA is now asking Congress to delineate and enhance its authorities over compounding pharmacies. Some in Congress have already voiced opposition to the idea, arguing that the agency already has too much power.