US Senate Committee on Health, Education, Labor, & Pensions

Harkin Applauds FDA’s Outreach Efforts in Moving Drug Compounding Law Forward

Friday, January 10, 2014

WASHINGTON, D.C.—Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee welcomed the announcement this week that the Food and Drug Administration (FDA) is moving forward with implementation of the Drug Quality and Security Act, which Harkin led to Senate passage in November 2013 and President Obama signed later that month.

The law will help ensure the safety of compounded drugs and is aimed at helping to prevent a future public health crisis like the 2012 meningitis outbreak tied to the New England Compounding Center and securing the pharmaceutical supply chain. 

As part of their effort to move forward with implementation of the law, FDA Commissioner Margaret Hamburg sent letters this week to state officials including governors, state boards of pharmacy and health departments. In the letters, Hamburg calls on them to take steps to encourage compounders that produce sterile drugs to register with FDA as outsourcing facilities.

“Thanks to the Drug Quality and Security Act, millions of patients and their families will have the peace of mind of knowing that their drugs are safe.  I applaud the FDA’s active outreach to state leaders across the country this week to move forward with implementation of this law,” Harkin said. “The 2012 meningitis outbreak tied to the New England Compounding Center led to 64 deaths and over 751 serious illnesses.  This law will reduce the likelihood that our country has to endure another tragedy from a compounded drug.”

“We’re already seeing progress with 14 outsourcing facilities registered with the FDA,” Harkin continued. “I urge state leaders in Iowa and around the country to continue this progress by working with the FDA and other health officials to move forward with the smooth and timely implementation of the law so that patients will have access to safe, high quality compounded drugs when they need them.”

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