We blogged last month about the nationwide outbreak of meningitis that originated in a Framingham, MA compounding pharmacy.
A consumer watchdog organization, Public Citizen, is now asking the Food and Drug Administration to re-inspect over a dozen specialty pharmacies with records of violations. Public Citizen sent a letter to the FDA on Thursday calling for the agency to re-examine 16 compounding pharmacies that received warnings from the FDA between 2003 and 2012.
Public Citizen decried what it says is the FDA’s recurring failure to follow up on warning letters to pharmacies. “By not fully investigating what could potentially be deadly violations of the law, the FDA is disregarding its primary purpose, which is to protect the lives of citizens,” said Dr. Michael Carome, Deputy Director of Public Citizen’s health unit.
The fungal meningitis outbreak that has killed 36 people and made ill more than 500 has been linked to contaminated pain injections from the New England Compounding Center of Framingham, MA.
The FDA inspected the New England Compounding Center three times before the outbreak and issued a warning letter in 2006, according to Congressional investigators. The letter addressed numerous violations, such as repackaging FDA-approved drugs into smaller doses and mass producing drugs without prescriptions.
Public Citizen wants the FDA to look into warning letters sent to pharmacies in 15 states for a number of violations, including: producing drugs from non-FDA approved ingredients, making copies of already approved drugs, and making compounds without a prescription from a doctor.
Public Citizen is a nonprofit advocacy organization based in Washington, D.C. and Austin, TX that lobbies on such issues as consumer rights, healthcare reform, and climate change. Ralph Nader founded the organization in 1971.
Fungal Meningitis Lawsuits
Our Massachusetts trial attorneys are prepared to aggressively represent individuals suffering harm from fungal meningitis and dangerous drugs. At Altman and Altman, LLP, we have been representing Massachusetts injury victims for the past 45 years. Our MA Personal Injury Attorneys are available around the clock.
Consumer Watchdog asks FDA to revisit compounders, keyc.tv, November 29, 2012.
Fungal Meningitis, www.CDC.gov, November 13, 2012