Reps. Green, Griffith, and DeGette Introduce Bipartisan Compounding Clarity Act

Press Release

Congressman Gene Green (D-TX), Congressman Morgan Griffith (R-VA), and Congresswoman Diana DeGette (D-CO) today introduced the Compounding Clarity Act (H.R. 3089), bipartisan legislation that would clarify Food and Drug Administration (FDA) authority over compounding, particularly large-scale entities like the New England Compounding Center (NECC) that act as drug manufacturers. Nationwide, there were 64 deaths and 750 confirmed cases of fungal meningitis resulting from tainted steroid injections.

Congressman Green said, "For the last several weeks, a bipartisan and bicameral group of lawmakers have been meeting to make sure we never relive the tragedy of the 2012 fungal meningitis outbreak that originated in a compounding pharmacy in Massachusetts. Congressman Griffith and Congresswoman DeGette have been exceptional leaders on addressing this public health threat and I believe this bill is a good step in that direction. These discussions have been productive and are ongoing, and by dropping this bill we are keeping the pressure on House leadership and maintaining the momentum we have built."

Congressman Griffith said, "As we approach the anniversary of the fungal meningitis outbreak that devastated so many families across the nation including Southwest Virginia, it is vital for Congress to take action to prevent another public health crisis. Since the outbreak, I have been working hand-in-hand with my friends across the aisle on a legislative solution that we are proud to be introducing today. This bipartisan proposal would prevent another NECC-type outbreak from occurring and ensuring the quality and safety of all compounded drugs in the country. The Compounding Clarity Act also requires the FDA to better communicate with state boards of pharmacy, and safeguards our local community pharmacies who were not at fault in last year's outbreak from burdensome federal regulations. I am grateful to Congressman Green and Congresswoman DeGette for their partnership and dedication, and look forward to our continued work on this issue."

Congresswoman DeGette said, "Almost a year has passed since a deadly fungal meningitis outbreak sickened hundreds across the United States. This rare incident was traced to contaminated steroid injections produced by a so-called compounding pharmacy. The outbreak, and subsequent troubling incidents, highlight the need for a stronger and more effective regulatory framework to oversee the compounding pharmacy system. That is why today I am pleased to join with my friends and colleagues Congressmen Griffith and Green to introduce the Compounding Clarity Act, a critical step in working to prevent these types of deadly outbreaks in the future. This bill represents a bi-partisan effort to develop a more robust regulatory framework that can save people's lives and I look forward to working together to see it become law."

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