Call For A Free Consultation

866-822-8237

Our Results

Senators Jab FDA Over Lethal Meningitis Outbreak

Sen. Tom Harkin, D-Iowa, in 2011.

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 5th amendment 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.

Source: http://www.nationaljournal.com/blogs/influencealley/2012/11/senators-jab-fda-over-lethal-meningitis-outbreak-15

No Comments

Leave a comment
Comment Information

Local Affiliation With Accomplished Trial Lawyers

Our partners are available as local counsel to out-of-state law firms in Michigan medical malpractice and personal injury litigation.Inquiries and referrals welcome.

Email Us For a Response

Reach Out To Us Today

Bold labels are required.

Contact Information
disclaimer.

The use of the Internet or this form for communication with the firm or any individual member of the firm does not establish an attorney-client relationship. Confidential or time-sensitive information should not be sent through this form.

close

Privacy Policy

Goethel Engelhardt, PLLC
3049 Miller Road
Ann Arbor, MI 48103

Toll Free: 866-822-8237
Phone: 734-545-8421
Fax: 734-769-7935
Ann Arbor Law Office Map

google plus
map
Review Us