by Tom Wilemon of The Tennessean and Paul C. Barton, Tennessean Washington Bureau
Relatives of people who have died or been sickened in the fungal meningitis outbreak came to Washington, D.C., hoping for action from politicians.
Joyce Lovelace, the widow of Kentucky Judge Eddie Lovelace, asked for bipartisanship. Melanie Norwood of Hermitage, whose mother has been hospitalized for almost seven weeks, said Congress should do something to prevent repeat tragedies.
But questions and statements from Democrats and Republicans on a U.S. House of Representatives committee revealed a gulf between the two parties on whether the Food and Drug Administration needed clearer authority to regulate compounding laboratories or whether the agency simply failed to do its job.
Today a Senate committee will hold its hearing into the outbreak that has sickened 461 people, killing 32 of them, including 13 in Tennessee. The victims have ranged from octogenarians enjoying their golden years to a 16-year-old high school football star from Virginia. Medicine mass-produced at New England Compounding Center in a dirty, moldy lab has been linked to the fungal infections.
Lovelace and other victims did get to see what Barry Cadden, the president and co-owner of New England Compounding Center, looked like, but they did not hear an explanation or an apology. Cadden repeatedly pleaded the Fifth Amendment, citing his constitutional right against self-incrimination, then walked out of the room after U.S. Rep. Cliff Stearns, the chairman of the subcommittee on oversight and investigations for the House Energy and Commerce Committee, dismissed him.
"What explanation can you give to those who have lost their loved ones?" asked Stearns, R-Fla., in one of many hostile questions directed at Cadden.
Cadden, in citing the Fifth Amendment, said he was doing so on the advice of his attorneys, who escorted him in and out of the committee room for his brief appearance.
Republican lawmakers also held nothing back in grilling FDA Commissioner Margaret Hamburg about why the agency did not act against NECC in the mid-2000s, despite its awareness of dangerous conditions there.
"This was a complete and utter failure on the part of your agency," Stearns said.
Hamburg, who did not become FDA commissioner until 2009, repeatedly declined to give a yes-or-no answer to questions about whether her agency could have shut down NECC, frustrating Republican members.
"Unfortunately, we have an unclear, fragmented regulatory framework," she said, adding that Congress needs to clarify her agency's authority over large-scale, "nontraditional" compounders like NECC.
Although 1938 food and drug laws give the FDA authority over anything considered prescription medicine, the agency has traditionally left it to state agencies to oversee small-scale compounders such as neighborhood druggists.
Rep. Henry Waxman, D-Calif., said he found it ironic that Republicans complain of federal regulators stifling businesses until something like the meningitis outbreak changes their minds.
"The regulators deserve blame, but the primary blame, in my mind, is the company," Waxman said.
However, Waxman also had criticism for the FDA.
"I would have assumed I had jurisdiction," he said. "I would have acted."
Many Republican members, led by Rep. Joe Barton of Texas, told Hamburg her agency needs to use authority it already has rather than asking for new powers.
Lawmakers also made it clear they thought the Massachusetts Department of Public Health deserved considerable blame as well.
Lauren Smith, who took over as interim commissioner of the Massachusetts agency just three weeks ago, acknowledged it had the authority to shut down the plant.
Massachusetts regulators were misled, she said, when the firm Pharmaceutical Systems Inc. was hired in 2006 to evaluate NECC's practices. It turned out PSI executives had criminal records that involved defrauding the FDA. And some Board of Pharmacy staff who knew about those crimes did not immediately disclose the information to the full board.
As a result, Massachusetts gave NECC a clean bill of health that year. In the wake of this fall's outbreak, however, the state has moved to permanently revoke the firm's license.
As Massachusetts works to raise its own standards, Smith said, "we urge Congress to act to strengthen federal oversight. It is not clear that the patchwork of disparate state regulations is enough to keep the public safe."
Joyce Lovelace, the first witness and the widow of Judge Eddie Lovelace, spoke without notes, saying her husband had hated prepared statements. He died after receiving steroid injections at Saint Thomas Outpatient Neurosurgery Center in Nashville.
Lovelace said the regulatory failures had left her family bitter and angry.
"I come here begging you to do something about this," she said. "I don't care what party - work together."
U.S. Rep. Marsha Blackburn, R-Tenn., wanted to know why the FDA failed to act after Colorado sent out an alert that NECC was shipping drugs without individual prescriptions in 2011.
"That complaint came in to you well in advance of any of these contaminated lots being shipped, is that correct?" Blackburn asked Hamburg.
"Did you even pick up a telephone and call the Massachusetts Board of Pharmacy and say, 'We think we have a repeat offender?' "
The communications were via email, Hamburg said.
Blackburn also published an opinion column Wednesday on The Hill.com, saying she supports action to prevent a future outbreak but wants to protect patients' access to traditional compounding pharmacies.
Blackburn's campaign received $5,000 from the International Association of Compounding Pharmacists political action committee in 2010 and again in 2012, according to the PAC's website.