NEWS: Media Outlets Report on Committee Report on Meningitis Outbreak

April 17, 2013

On Tuesday, the Subcommittee on Oversight and Investigations, chaired by Rep. Tim Murphy (R-PA), held its second hearing on the fungal meningitis outbreak resulting from contaminated injections made by the New England Compounding Center (NECC) and shipped to healthcare facilities across the country. To date, the outbreak has claimed 53 lives and left over 700 others with severe health issues. The subcommittee heard from FDA Commissioner Margaret Hamburg as part of its ongoing investigation of the FDA’s history with NECC and its sister company, Ameridose, to determine whether this tragedy could have been prevented had the agency taken action under its existing authorities.

Prior to the hearing, the Energy and Commerce Committee released a majority staff report. Citing internal documents from the Food and Drug Administration, the report showed that the agency failed to act on many of the numerous warnings and complaints it received about the pharmacy that produced and distributed the contaminated drugs that led to the deadly meningitis outbreak. Among the investigation’s findings: FDA received complaints about NECC and its sister company, Ameridose, right up until the 2012 outbreak related to the safety and potency of NECC and Ameridose products. The committee also found that FDA failed to share these complaints with the state regulators so they could take action against the companies. Finally, FDA also considered - but never conducted - several additional inspections of the companies and related enforcement actions that, had they happened, may have adverted the tragedy.

Report: FDA had many complaints on Mass. pharmacy
A report issued by Republicans blasts the agency for failing to act on complaints.
April 16. 2013

House Republicans said Tuesday that the Food and Drug Administration should have acted years earlier to close the Massachusetts pharmacy responsible for a deadly meningitis outbreak tied to contaminated medications.

A report issued by Republicans blasts the FDA for failing to act on years of complaints about problematic drugs and practices at the New England Compounding Center. The compounding pharmacy produced tainted pain injections that have sickened more than 700 Americans and killed 53 others. …

Republicans on the House subcommittee investigating the outbreak said that the FDA should have closed the NECC based on complaints from doctors, patients, hospitals and drug distributors. The FDA first inspected the pharmacy in 2002 and issued a warning letter in 2006 for mass-producing copies of manufactured drugs. Beginning in 2007 and continuing through 2012 the FDA continued to receive complaints about the company from anonymous informants and state pharmacy regulators, according to internal documents released by the committee. …

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Congressional report says FDA faltered in deadly meningitis outbreak
April 16, 2013

The Food and Drug Administration failed to act on warnings about contaminated drugs produced by a Massachusetts company linked to last year’s meningitis outbreak that killed 53 people and sickened hundreds more, a congressional committee report said on Tuesday.

The House Energy and Commerce Committee report concluded that the tragedy might have been prevented if the FDA had taken tougher enforcement action against the New England Compounding Center (NECC) and ordered state inspections of drug-producing facilities.

“Going into this investigation, we knew NECC and its sister company, Ameridose, were bad actors. But what makes this tragedy even more heartbreaking for these families is that this could have been prevented,” Chairman Fred Upton (R-MI) and Oversight and Investigations Subcommittee Chairman Timothy Murphy (R-PA) said in a joint statement. …

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House Republicans fault FDA on meningitis outbreak
April 16, 2013

After reviewing 27,000 pages of documents from the Food and Drug Administration, Republicans and Democrats came to different conclusions about the agency’s ability to prevent one of the worst public health crises in American history.

Republican members of the House Energy and Commerce Committee said Tuesday that its six-month investigation into the FDA’s role in last fall’s meningitis outbreak shows the agency knew for a decade about serious safety lapses at the specialized pharmacy that made the tainted drugs but failed to act. …

The documents show that, dating back to at least 2002, the FDA had received and largely ignored complaints from doctors, nurses and whistleblowers about safety problems at the NECC, according to the majority report from the Republicans. The complaints prompted two inspections, but, even as new complaints rolled in and after the agency issued a warning letter in 2006, the FDA did not return to the facility until after the outbreak.

“We know now that 53 Americans did not need to die,” said the committee chairman, Rep. Fred Upton (R-Mich.). “It sickens me that this could have been avoided.” ...

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