November 15, 2012
The Food and Drug Administration was the subject of tough criticism from Democrats and Republicans today at a Senate panel investigating a deadly meningitis outbreak.
The Senate Health, Education, Pensions and Labor Committee held a hearing on tainted drugs produced by the New England Compounding Center that have killed 32 people and sickened more than 400 with a rare form of meningitis. The FDA sent the New England pharmacy a warning letter in 2006 admonishing them for inappropriate manufacturing practices, but ultimately took no action to stop production at the facility.
Committee Chairman Tom Harkin, D-Iowa, used the hearing as a forum to call for better public health infrastructure and funding, saying Congress has treated public health as the “step child of health in America.” He told the FDA he understood that their authority to regulate the pharmacy was unclear, but wanted to focus on how to fix the current situation.
“I have some sympathy for the FDA not knowing exactly what its role is going to be, but that’s OK, that’s in the past,” Harkin said.
Other members had tough words for FDA Commissioner Margaret Hamburg. Sen. Pat Roberts, R-Kansas, wanted Hamburg to answer "yes" or "no" to whether the FDA had the propoer authority to shut down NECC.
“It's not a yes or no answer,” Hamburg said. “We have authority but it is limited and unclear and contested.”
“Well, that’s a hell of an authority,” Roberts said. “Why in the hell send the warning letters if you can’t act on them?...If this is an empty threat, why do we even have an FDA? Why do you have a job?”
Democrats also criticized the FDA, which is asking for broader authority to regulate compounding pharmacies like the one responsible for the outbreak.
“I think that a lot of the questioning that you are seeing here reflects a skepticisim on the part of Congress and the public about whether the FDA will use this enhanced authority more effectively than the authority it has had up to date,” Sen. Richard Blumenthal, D-Ct., said.
Barry Cadden, the co-owner and chief pharmacist at NECC, declined to testify at the hearing. He was subpoenaed and appeared at the House Energy and Commerce hearing Wednesday, but invoked his 5thamendment rights to not incriminate himself. Harkin said the Senate committee did not subpoena Cadden.
“There’s no reason to go through that charade today with him,” Harkin said.
November 15, 2012