U.S. Senator Kay Hagan, a member of the Senate Health, Education, Labor and Pensions (HELP) Committee, joined with Committee Chairman Tom Harkin (D-IA), Ranking Member Mike Enzi (R-WY), and fellow committee members in sending letters to state and federal regulators and private companies involved in the recent fungal meningitis outbreak, which has sickened 308 people nationwide and led to 23deaths, including one in North Carolina.
Hagan and her colleagues, in three separate letters, requested information from the U.S. Food and Drug Administration (FDA), the Massachusetts Board of Registration in Pharmacy and the New England Compounding Center (NECC) to better understand how large quantities of contaminated drugs were distributed throughout the country.
"We are deeply concerned about the recent outbreak of fungal meningitis and related infections," Hagan and her colleagues wrote in their letter to the Massachusetts Board of Pharmacy. "The outbreak, which has been linked to a compounding pharmacy in Massachusetts, has raised serious questions about the level of oversight that this entity was subject to, both by state and federal regulators. We write to request information regarding the Board's interactions with the pharmacy in question, in order to better understand the circumstances that led to the present outbreak."
· The letter to the Massachusetts Board of Pharmacy requests a series of documents and information pertaining to their inspections of the NECC facilities and how they determine a pharmacy is in compliance with state law.
· The letter to the FDA requests information about complaints received regarding all compounded products and the agency's protocol for addressing these complaints. Specifically, the letter asks the FDA to provide information following those complaints for NECC in particular.
· The letter to NECC requests a list of the states where the company is licensed, copies of all communications with the FDA and the Board of Pharmacy and all communications from customers and clients relating to concerns about quality, sterility, or safe manufacture of drug products. With regards to NECC specifically, the letter asks for a timeline of all federal and state regulatory inquiries into complaints, all internal documents regarding the outbreak of fungal infections as a result of the contaminated lots, and a list of every drug compounded by NECC since the start of 2012. The Committee also asks NECC to provide an explanation for why they were not licensed as a manufacturer under the Federal Food Drug and Cosmetic Act, given the scope and national scale of its drug production and distribution.