Congress Investigates: FDA, NECC and the Meningitis Outbreak!

posted by Dr. Ad Versery Bored @ 10:30 AM
November 21, 2012

    To watch the full length of Congressional Hearings on the New England Compounding Center (NECC) debacle was both painful and infuriating.  Painful to watch Margaret Hamburg, Food and Drug Administration (FDA) Commissioner, squirm from discomforting questions.  Infuriating to see Barry Cadden, NECC co-owner, plead fifth amendment Constitutional protection to avoid responsibility.

I agree with what David Morgan and Bill Berkrot report for Reuters in ‘U.S. Congress Takes Aim at FDA Over Meningitis Outbreak’:  “In a highly contentious hearing that lasted four hours, committee members repeatedly accused FDA Commissioner Dr. Margaret Hamburg of failing to answer questions about FDA authority and a lack of action against NECC.

“Hamburg in turn insisted that the FDA lacks clear authority to regulate compounding pharmacies due to conflicting court rulings and other regulatory ambiguities.”  And so they went round and round, with neither side giving in.  Hamburg never admitted that FDA should have done more.  But she should have!

Instead Hamburg repeatedly asked Congress to more clearly define FDA’s authority over compounding agencies, and (with the help of maps showing limited FDA oversight) craft laws preventing regional courts from siding with compounding businesses to prevent FDA oversight. Yet the nation cannot be comforted by Hamburg’s defensiveness.  While she lamented those killed and sickened by NECC negligence, she accepted no responsibility for FDA’s failures.

In contrast, Dr.  Lauren Smith, recently appointed Interim Commissioner of the Massachusetts Department of Public Health, had fired or demoted staff members for failed oversight of NECC.  And she had also sent Congress all files related to these incidents.  Hamburg, meanwhile, has held none of her staff accountable, and she has not supplied Congress any files on the various cases.

So the Congressional Committee (which is on vacation this week) is suppose to write laws to straighten out this mess before the end of the year.  It won’t happen, because:  1)  According to Hamburg, the FDA has no idea how many compounding agencies are operating in this country, nor does it know the volume of drugs these agencies mix and ship across the country or to servicemen overseas;

2)  Apparently the FDA has different rules and protocols of authority and communication with 50 individual states––there is no ‘one size fits all’ rule in place; 3) Also no protocol exists to compel states to communicate with the FDA or with one another about possible renegade compounding companies; 4)  Congress has not held sufficient oversight over the FDA or compounding agencies since 1997, and even then their laws were vague, without definitions of pharmacies or compounders, or other essentials, etc., etc., etc.

Our nation’s only hope is prayer and dependence upon God’s grace. As used Christian books tell us: “For by grace are ye saved through faith; and that not of yourselves: it is the gift of God (Ephesians 2: 8).” How we thank God for that gift!

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