Senators jab FDA over lethal meningitis outbreak

Pouya Dianat/AP file photo

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.

Stay up-to-date with federal news alerts and analysis — Sign up for GovExec's email newsletters.
Close [ x ] More from GovExec

Thank you for subscribing to newsletters from
We think these reports might interest you:

  • Forecasting Cloud's Future

    Conversations with Federal, State, and Local Technology Leaders on Cloud-Driven Digital Transformation

  • The Big Data Campaign Trail

    With everyone so focused on security following recent breaches at federal, state and local government and education institutions, there has been little emphasis on the need for better operations. This report breaks down some of the biggest operational challenges in IT management and provides insight into how agencies and leaders can successfully solve some of the biggest lingering government IT issues.

  • Communicating Innovation in Federal Government

    Federal Government spending on ‘obsolete technology’ continues to increase. Supporting the twin pillars of improved digital service delivery for citizens on the one hand, and the increasingly optimized and flexible working practices for federal employees on the other, are neither easy nor inexpensive tasks. This whitepaper explores how federal agencies can leverage the value of existing agency technology assets while offering IT leaders the ability to implement the kind of employee productivity, citizen service improvements and security demanded by federal oversight.

  • IT Transformation Trends: Flash Storage as a Strategic IT Asset

    MIT Technology Review: Flash Storage As a Strategic IT Asset For the first time in decades, IT leaders now consider all-flash storage as a strategic IT asset. IT has become a new operating model that enables self-service with high performance, density and resiliency. It also offers the self-service agility of the public cloud combined with the security, performance, and cost-effectiveness of a private cloud. Download this MIT Technology Review paper to learn more about how all-flash storage is transforming the data center.

  • Ongoing Efforts in Veterans Health Care Modernization

    This report discusses the current state of veterans health care


When you download a report, your information may be shared with the underwriters of that document.