Barton calls meningitis outbreak “an absolute tragedy,” criticizes lack of regulator response
Tells packed hearing: “You can take a regulator to a problem, but you can’t make them regulate.”
WASHINGTON, DC: Congressman Joe Barton (R-TX) delivered the attached opening statement at Tuesday’s Subcommittee on Oversight and Investigations hearing titled “The Fungal Meningitis Outbreak: Could It Have Been Prevented?”
The FDA showed up at the hearing asking Congress for more regulatory authority. However, during a tense exchange (included in video), Rep. Barton got agency leaders to admit they already had the power to remove the tainted drugs at the heart of the meningitis outbreak from the market.
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Opening Statement of the Honorable Joe Barton
Subcommittee on Oversight and Investigations, Hearing
“The Fungal Meningitis Outbreak: Could It Have Been Prevented?”
November 13, 2012
Submitted for the record:
Thank you Mr. Chairman for holding this important hearing. Unfortunately, we sit here today to review the facts and figure out what could have been done differently to prevent the recent outbreak of fungal meningitis that has left 32 innocent people dead.
The contamination comes from an injectable steroid compounded and distributed by the New England Compounding Center (NECC). When you read the Committee Memo for this hearing and the recent media reports, you can’t help but ask “how did this happen?”
For over a decade, the State of Massachusetts and the Food and Drug Administration (FDA) have been investigating and expressing concerns about the compounding practices at NECC. It appears that a perfect storm was forming. The facts indicate that the President of NECC, Barry Cadden, acted negligently and his facility was plagued with sterilization problems, the state and federal government received numerous complaints about the NECC and practiced a lot of bureaucratic hula-hooping, and ultimately they both failed to take formal action against the NECC in time to prevent this current catastrophe.
In Texas we have a saying, you can lead a horse to water, but you can’t make it drink. Well the same is true in this situation. You can lead the regulators to a problem, but you can’t make them regulate.
The public deserves answers from the NECC, the FDA, and the Massachusetts Department of Public Health, all of whom were invited to testify today, and this Committee will not stop our investigation until we get them.