Congressional report says FDA faltered in deadly meningitis outbreak
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.
The committee’s majority staff report cited internal FDA documents chronicling the agency's opportunities over the years to address warning signs about NECC that produced and distributed the contaminated drugs that led to the deadly meningitis outbreak.
Compounding pharmacies, which mix customized medications, have usually been overseen by state pharmacy boards. But the growth of larger operations like NECC which mass produce thousands of drugs across the United States, has prompted calls for more federal oversight.
Last October, the Oversight and Investigations Subcommittee launched an investigation to examine the deadly outbreak in which 53 died and over 700 were sickened, and to determine whether the tragedy could have been prevented.
Tuesday’s report revealed that FDA Commissioner Margaret Hamburg did not disclose some key information during a November hearing. She did not say that the agency had received a litany of complaints about NECC and Ameridose, right up until the outbreak. A number of these complaints were associated with issues different in nature and scope than those addressed in a 2006 warning letter sent to NECC, the report said.
These complaints were related to the safety and potency of NECC and Ameridose products, issues that the FDA failed to routinely, if ever, inform the state about, it said. 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.
FDA spokesman Steven Immergut said the rapid growth of the pharmacy compounding industry had been a challenge for the agency's limited resources. "For years, FDA has been working with a limited set of authorities and tools to regulate the rapidly growing and evolving pharmacy compounding industry."
"We all need to urgently work together to fix this, and our hope is that the House Energy and Commerce Committee will work with FDA to put the appropriate laws and resources together," Immergut said.
However, a review of more than 27,000 documents presented a different picture of the FDA's actions than portrayed in the intial November hearing, Upton and Murphy said.
“We now know that doctors, patients, providers, and whistleblowers tried to warn FDA for years that NECC and Ameridose were operating as manufacturers and marketing their products nationwide without patient prescriptions, the statement said. “The FDA was also warned about sterility and safety issues with the companies' products. Rather than do its job and protect the patients who were taking NECC and Ameridose drugs, FDA chose not to act,” they said.
“We found that FDA focused on perfecting their legal reasons for inaction instead of protecting families. Even the FDA staff wanted to go back and inspect these unsanitary manufacturers. And the FDA hierarchy said ‘no,’ the committee chairmen said.
"We owe it to the families who lost loved ones and the 730 individuals still suffering to get answers from the FDA on why they failed to protect patients and how they will assure this never happens again,” said Upton and Murphy.
Related:
Pharmacy tied to fungal meningitis outbreak files for bankruptcy
More bacteria fungi in drugs from mass pharmacy
FDA wanted to close Mass. pharmacy in 2002, report says
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.
The committee’s majority staff report cited internal FDA documents chronicling the agency's opportunities over the years to address warning signs about NECC that produced and distributed the contaminated drugs that led to the deadly meningitis outbreak.
Compounding pharmacies, which mix customized medications, have usually been overseen by state pharmacy boards. But the growth of larger operations like NECC which mass produce thousands of drugs across the United States, has prompted calls for more federal oversight.
Last October, the Oversight and Investigations Subcommittee launched an investigation to examine the deadly outbreak in which 53 died and over 700 were sickened, and to determine whether the tragedy could have been prevented.
Tuesday’s report revealed that FDA Commissioner Margaret Hamburg did not disclose some key information during a November hearing. She did not say that the agency had received a litany of complaints about NECC and Ameridose, right up until the outbreak. A number of these complaints were associated with issues different in nature and scope than those addressed in a 2006 warning letter sent to NECC, the report said.
These complaints were related to the safety and potency of NECC and Ameridose products, issues that the FDA failed to routinely, if ever, inform the state about, it said. 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.
FDA spokesman Steven Immergut said the rapid growth of the pharmacy compounding industry had been a challenge for the agency's limited resources. "For years, FDA has been working with a limited set of authorities and tools to regulate the rapidly growing and evolving pharmacy compounding industry."
"We all need to urgently work together to fix this, and our hope is that the House Energy and Commerce Committee will work with FDA to put the appropriate laws and resources together," Immergut said.
However, a review of more than 27,000 documents presented a different picture of the FDA's actions than portrayed in the intial November hearing, Upton and Murphy said.
“We now know that doctors, patients, providers, and whistleblowers tried to warn FDA for years that NECC and Ameridose were operating as manufacturers and marketing their products nationwide without patient prescriptions, the statement said. “The FDA was also warned about sterility and safety issues with the companies' products. Rather than do its job and protect the patients who were taking NECC and Ameridose drugs, FDA chose not to act,” they said.
“We found that FDA focused on perfecting their legal reasons for inaction instead of protecting families. Even the FDA staff wanted to go back and inspect these unsanitary manufacturers. And the FDA hierarchy said ‘no,’ the committee chairmen said.
"We owe it to the families who lost loved ones and the 730 individuals still suffering to get answers from the FDA on why they failed to protect patients and how they will assure this never happens again,” said Upton and Murphy.
Related:
Pharmacy tied to fungal meningitis outbreak files for bankruptcy
More bacteria fungi in drugs from mass pharmacy
FDA wanted to close Mass. pharmacy in 2002, report says
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