Product News and Recalls

Regulators faulted over meningitis outbreak

A congressional report on the specialty pharmacy linked to a deadly meningitis outbreak has faulted state and federal regulators for failing to address serious safety concerns at the New England Compounding Center in Massachusetts, according to the Wall Street Journal.

A report by bipartisan staff of the Senate Health, Education, Labor and Pensions Committee, which met Thursday to examine the issue, concluded that regulators knew of problems at the pharmacy nearly a decade ago.

The NECC is the source of contaminated steroid medication that has caused the meningitis outbreak, which according to the U.S. Centers for Disease Control and Prevention has sickened 461 people and killed 32 in 19 states.

Meningitis is an inflammation of the tissue surrounding the spinal cord and brain.

The previous day, a House panel met to discuss the same issue. The pharmacy’s co-owner, Barry Cadden, invoked his constitutional rights against self-incrimination and refused to answer questions.

The case has raised concerns about compounding pharmacies such as NECC, which formulate specialty drugs from ingredients provided by other sources and are not subject to the same regulatory requirements as other pharmaceutical manufacturers.

At the hearing, Senators in both parties expressed interest in clarifying the FDA’s role in overseeing compounding pharmacies. But the Senators and their staff said the FDA still should have previously taken action against the NECC.

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://online.wsj.com/article/SB10001424127887323551004578121843796988744.html