Iowa Senator Tom Harkin is presiding over today’s hearing into the recent outbreak of fungal meningitis due to tainted drugs produced by the New England Compounding Center. More than 450 people were sickened in 19 states — and 32 people died.
Harkin, who chairs the Senate’s Health, Education, Labor and Pensions Committee, says the outbreak never should have happened. “I believe it could have been prevented if, in fact, legislation had been passed that was stymied a few years ago,” Harkin says.
“It would have given the FDA clear authority to investigate and to take action against that NECC in Massachusetts.” He says the measure was offered about six years ago and it would have granted the U.S. Food and Drug Administration much-needed new regulatory powers.
“That bill was basically killed by the compounding pharmacies association and their lobbyists here,” Harkin says. “Had we had that bill pass, then FDA would have had clear lines of authority to crack down on that facility in Massachusetts.” Harkin says FDA Commissioner Margaret Hamburg is scheduled to testify before the panel this morning.
The pharmacy in question is the suspected source of tainted steroid injections, which were to be used for back and joint pain. The N-E-C-C closed after the outbreak first appeared last month and the facility had a long record of alleged problems.