May 10, 2013

Sen. Warren's Remarks at HELP Committee Hearing on Pharmaceutical Compounding

WASHINGTON, DC – At a Senate Health, Education, Labor, and Pensions (HELP) Committee hearing today (5/9), Sen. Warren discussed the ongoing public health threat posed by inadequate regulation of the pharmaceutical compounding industry. Massachusetts was home to New England Compounding Center, the compounding pharmacy responsible for a fungal meningitis outbreak that killed 53 people and made 733 ill.

“As the senior Senator from Massachusetts, I feel a special duty to ensure that we do everything possible to protect people from unsafe drugs,” said Senator Warren. “The current state of our oversight of the compounding industry is outdated and inadequate. It represents a continuing public health threat in need of federal legislative action.”

The outbreak caused by drugs from the New England Compounding Center resulted in part from long-standing failures of government regulation, lack of coordination between state and federal oversight, and lack of clarity in the existing guidelines. The HELP Committee has released draft legislation on this issue. 

“I am very pleased that Democrats and Republicans on this Committee have been able to come together over the last several months to develop this draft legislation,” Senator Warren said. “I’m pleased because we all agree that a tragedy like this should not happen again, that it can be prevented, and it’s our job to prevent it.”

During today’s hearing, Senator Warren also asked questions of Dr. Janet Woodcock, the Director of the Center for Drug Evaluation and Research at the Food and Drug Administration; Carmen S. Catizone, Executive Director of the National Association of Boards of Pharmacy; Alan Coukell, Director of Medical Programs at the Pew Charitable Trusts; David G. Miler, Executive Vice President and CEO of the International Academy of Compounding Pharmacy; and Dr. Kasey K. Thompson, Vice President, Office of Policy, Planning, and Communications for the American Society of Health-System Pharmacists. 

To watch video of Senator Warren’s remarks and Q&A, click here.