Product News and Recalls

FDA director testifying on meningitis outbreak

A story in the Boston Globe says congressional representatives investigating a deadly fungal meningitis outbreak have called FDA Commissioner Dr. Margaret Hamburg to testify at a House Energy and Commerce Committee hearing.

Hamburg is also scheduled to testify at a U.S. Senate hearing on the issue.

A co-founder of the New England Compounding Center, the Massachusetts-based specialty pharmacy behind the outbreak, has been invited to testify as well.

The meningitis cases have been tracked to fungus-contaminated injectable steroid medication manufactured at the NECC. Meningitis is an inflammation of the tissue surrounding the spinal cord and the brain.

According to the U.S. Centers for Disease Control and Prevention, the steroids have generated 419 cases in 19 states, including 30 deaths. Federal and state inspectors recently found unsafe conditions at the NECC.

Compounding pharmacies such as the NECC craft specialized medications from ingredients provided by other sources, for doctors who place special orders on behalf of individual patients. But some pharmacies such as the NECC have grown into large operations that supply bulk orders of medicines to thousands of doctors and hospitals across the country.

The story points out that compounding pharmacies exist in a “legal grey area” between state and federal laws, which has enabled them to escape FDA oversight. Now members of the House and Senate are looking into a recommendation from FDA officials that the federal government’s role in overseeing compounding pharmacies should be clarified.

Lopez McHugh is investigating cases related to this outbreak. If you or a loved one had an injection and were diagnosed with meningitis, you should consult with a Lopez McHugh lawyer for a free consultation.

See the story here:

http://www.boston.com/business/news/2012/11/05/fda-chief-will-testify-first-meningitis-hearing/KgN9Di3r828vAW7bHanJMO/story.html