Congressional hearing slated on meningitis outbreak

January 12th, 2015

The U.S. Senate Committee on Health, Education, Labor and Pensions will hold a hearing Thursday, Nov. 15, 2012 at 10:00 AM on a national meningitis outbreak that has led to 438 infections and 32 deaths in 19 states.

A link to a webcast of the event should be available at the committee website .

The committee previously sent letters to the New England Compounding Center, the Massachusetts Board of Pharmacy, and the U.S. Food and Drug Administration seeking records that will help it better understand how the outbreak occurred and what warning signs may have existed.

The committee is expected to consider if additional federal regulation and oversight is needed over compound pharmacies.

In a letter to the FDA Committee Chairman Tom Harkin (D-IA) asked the agency to provide copies “of any written procedures or guidelines for addressing complaints against or inspections of compounding pharmacies. Please include procedures for contacting and coordinating with state regulatory authorities and procedures for coordinating access to sales, distribution and prescription records, as well as whether the agency has entered into any Memoranda of Understanding with States or relevant regulating agencies regarding compounding pharmacies and compounding pharmacy inspection procedures. Also please include a copy of any written procedures or guidelines for enforcement action such as warning letters, seizures, or injunctions.”

Slated witnesses for the hearing, which will be held at the Dirksen Senate Office Building, include the following:

• Dr. Beth Bell , Director, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA
• Dr. Peggy Hamburg , Commissioner, Food and Drug Administration, Washington, DC
• Dr. Lauren Smith , Interim Commissioner, Department of Public Health, Boston, MA
• Barry Cadden , Owner and Director of Pharmacy, New England Compounding Center, Framingham, MA
• David G. Miller , Executive Vice President and CEO, International Academy of Compounding Pharmacy, Missouri City, TX
• Dr. Kasey K. Thompson , Vice President, Office of Policy, Planning and Communications, American Society of Health-System Pharmacists, Bethesda, MD