FDA Commissioner Margaret A. Hamburg, MD, today told a congressional panel investigating the deadly fungal meningitis outbreak tied to the New England Compounding Center (NECC), in Framingham, Mass., that current law “is not well suited” to regulate large compounding pharmacies.
“Sterile products produced in advance of or without a prescription and shipped interstate should be subject to the highest levels of controls, established by FDA and appropriate to the activity, similar to cGMP [current Good Manufacturing Practices] standards applicable to conventional drug manufacturing,” Dr. Hamburg told the House Energy and Commerce Subcommittee on Oversight and Investigations.
“We have been hampered in our ability to protect the American people because of ambiguities regarding FDA’s enforcement authority, legal challenges and adverse court decisions” surrounding what she termed nontraditional compounders—companies that produce large quantities of sterile products “in advance of or without receiving a prescription, where the drug is distributed out of [the] state in which it was produced.”
The House hearing was the latest in a series of congressional inquiries following last year’s deadly outbreak of meningitis associated with contaminated compounded methylprednisolone acetate produced by NECC. To date, more than 50 people have died and about 730 have been stricken in 20 states.
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“Sterile products produced in advance of or without a prescription and shipped interstate should be subject to the highest levels of controls, established by FDA and appropriate to the activity, similar to cGMP [current Good Manufacturing Practices] standards applicable to conventional drug manufacturing,” Dr. Hamburg told the House Energy and Commerce Subcommittee on Oversight and Investigations.
“We have been hampered in our ability to protect the American people because of ambiguities regarding FDA’s enforcement authority, legal challenges and adverse court decisions” surrounding what she termed nontraditional compounders—companies that produce large quantities of sterile products “in advance of or without receiving a prescription, where the drug is distributed out of [the] state in which it was produced.”
The House hearing was the latest in a series of congressional inquiries following last year’s deadly outbreak of meningitis associated with contaminated compounded methylprednisolone acetate produced by NECC. To date, more than 50 people have died and about 730 have been stricken in 20 states.
Continue reading here
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