Lawmakers posed tough questions during recent hearings on the deadly meningitis
outbreak tied to tainted drugs manufactured by the New England Compounding
Center. The primary concern is whether regulators like the Food and Drug
Administration could have prevented the crisis.
The investigation into the deadly outbreak has revealed that the NECC had
a checkered safety history, with problems dating back to 1999. As
Reuters reports, the FDA and Massachusetts regulators identified sterilization issues
more than 10 years ago after patients were hospitalized with similar meningitis-like symptoms.
The Massachusetts Board of Registration in Pharmacy, which is tasked with
overseeing NECC, has been criticized for failing to carry out sanctions
against the company. The FDA has also received part of the blame, but
it contends that it lacks the authority to implement strong oversight
of compounding pharmacies under current legal precedent and regulations.
“This isn’t, sadly, an isolated incident. This is the worst
and most tragic. It should be the last wakeup call for us,” FDA
Commissioner Margaret Hamburg stated.
“We really need a strong, clear and appropriate legislation. We cannot
have a crazy quilt where different parts of the country are subject to
different legal frameworks,” she told the committee.
Meanwhile, Barry Cadden, who owns the company ultimately responsible for
the contaminated drugs, refused to answer any questions from the committee,
citing his right to not incriminate himself under the fifth amendment
of the U.S. Constitution.