On the heels of a report from the U.S. Food & Drug Administration regarding the increasing list of safety standard failures at a Massachusetts compounding pharmacy blamed for a deadly national meningitis outbreak, a scathing report from Congress slams the FDA for its inaction.
Our Boston medical malpractice lawyers understand that the report, issued by House of Representative Republicans, claims the federal regulator should have acted years ago to shutter the New England Compounding Center. You may recall from earlier blog entries that contaminated pain injections produced by the company last year reportedly resulted in 53 deaths and more than 700 illnesses throughout the country. It was one of the worst outbreaks of medication-related illness in our national history.
The company was forced to close in October, and as of right now, faces more than 100 lawsuits.
Six months after the NECC was forced to close, an ongoing debate rages about whether this awful tragedy might have been preventable. The resounding answer appears to be: Yes.
A House subcommittee has been investigating the issue since last fall. What they have so far concluded is that the center should have been boarded up years ago. The House leaders pinned responsibility for the fact that it wasn’t squarely on the FDA.
The first time the federal agency inspected the facility was 13 years ago. Four years later, in 2005, the regulator submitted a warning to the firm, noting the illegal practice of mass-producing replicas of drugs that were already being manufactured.
Compounding pharmacies are tapped as sources of customized drug mixes based on individual doctor prescriptions. Mass production of other types of standard drugs by these firms is illegal.
Over the course of the next five years, the FDA was flooded with complaints about the NECC. Some were from anonymous informants. Others were from state pharmacy regulators, doctors, hospitals, drug distributors and patients. This was all backed in documents the FDA handed over to the House Energy and Commerce Subcommittee on Oversight and Investigations for its research. The fact that the FDA essentially did nothing to halt this clearly troubled operation speaks volumes about what we can expect – or can’t expect – when we receive medicine.
As Rep. Tim Murphy (R-PA) noted, the FDA had a decade of flashing red lights, warning signs and alarm bells. Yet, all of that was either blatantly ignored or resulted in a minor slap on the wrist – even though these violations could – and later did – result in serious injury or death.
The FDA’s commissioner, Margaret Hamburg, testified before the subcommittee and appealed for a greater amount of oversight when it comes to the compounding industry, which in the last 25 years has been aggressive in court challenges of federal regulatory authority. She said her agency is trying to become more active on this front, but the laws and court decisions regarding the FDA’s legal boundaries are spotty and conflicting.
House Democrats on the committee, while also critical of the FDA’s response, did concede that the agency needs clearer authority to be able to act more decisively in the future.
The late Ted Kennedy, D-Massachusetts, introduced such a bill but it was not passed by fellow members of Congress.
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Report faults FDA for not closing Mass. pharmacy, April 17, 2013, By Matthew Perrone, The Boston Globe
More Blog Entries:
FDA Finds More Problems at Compounding Pharmacies, April 15, 2013, Boston Personal Injury Lawyer Blog