SUNDAY, JULY 22, 2018

House holds contentious hearing with FDA commissioner

Lawmakers bickered consistently during a recent investigative hearing with U.S. Food and Drug Commissioner Margaret Hamburg over the fungal meningitis outbreak caused by contaminated steroid injections.

The four hour House Subcommittee on Oversight and Investigations hearing was tense, with subcommittee members repeatedly pressing Hamburg for an explanation as to how the pharmacy at the center of the outbreak was allowed to continue operating despite years of problems, according to NPR.

The New England Compounding Center, located in Massachusetts, produced the contaminated batch of injections that have so far killed 32 people and sickened 460.

"Do you think the FDA had the authority to shut down NECC, yes or no?" Committee Chairman Rep. Cliff Stearns (R-Fla.) asked Hamburg, NPR reports.

Those present at the meeting, including Stearns and Hamburg, interrupted each other frequently throughout the proceedings, with the most heated exchanges occurring when Hamburg was called to sit in the witness chair. At that point, Stearns demanded to know how the FDA could let the pharmacy continue to operate for years after it sent a warning letter in 2006.

"The fact is the warning letter did not involve sterility failures and it was not in relation to the kinds of problems that we're addressing now," Hamburg said, NPR reports.

"So you're saying your warning letter was an empty threat?" Stearns replied, according to NPR.

Hamburg made it clear he felt the FDA did everything it could, but was hampered by a lack of clear legal authority over compounding centers like NECC. She said conflicting court rulings left the FDA's role unclear.

"We have ambiguous, fragmented, unclear and contested authorities in this particular realm of pharmacy and drug-manufacturing practice," Hamburg said, NPR reports.

Several Republican members of the subcommittee took the opportunity to express doubt that the FDA was boxed in by authoritative or regulatory constraints.

"I think we ought to work on using the authority that we have as opposed to trying to get additional authority at the federal level," Rep. Joe Barton (R-Texas) said, NPR reports.