Griffith, Green, DeGette Support Bipartisan, Bicameral Compounding Agreement
Congressman Morgan Griffith (R-VA), Congressman Gene Green (D-TX), and Congresswoman Diana DeGette (D-CO) participated in a series of Energy and Commerce hearings on the drug compounding issue. They recently introduced the Compounding Clarity Act (H.R. 3089), and today signed on as cosponsors of the Drug Quality and Security Act. The Drug Quality and Security Act, which incorporates some of the Compounding Clarity Act, is a bipartisan, bicameral first step to help ensure the safety of compounding drugs. It also will work to prevent a national public health crisis like the 2012 fungal meningitis outbreak tied to the New England Compounding Center (NECC). 64 deaths and 750 confirmed cases of fungal meningitis resulted from tainted steroid injections from the NECC.
Griffith said, “The Drug Quality and Security Act is a first step at clarifying current law. It eliminates perceived confusion that existed as a result of court decisions on advertising related to compounding drugs and adopts the notification provisions that were in the Griffith-Green-DeGette Compounding Clarity Act. The Drug Quality and Security Act leaves a large portion of existing law intact. It also leaves many areas of practice where clarification may still be needed, particularly as it relates to office use, repackaging, and nuclear pharmacies. Along with my colleagues, I will continue working to oversee the FDA’s interpretation and implementation of this law.”
Green said, “The Drug Quality and Security Act is a positive step forward toward enhancing public health and ensuring that compounded drugs are safe and dependable. I am proud to have worked with my colleagues Reps. Griffith and DeGette in pressing for enhanced FDA oversight of compounding. While I believe the FDA dropped the ball with regards to the NECC, with this law they must succeed where in the past they failed. This bill still lacks clarity in many important areas: office use, how nuclear pharmacies are regulated, and repackaging of sterile products. I look forward to working with my colleagues to provide meaningful oversight of the FDA to make sure another NECC type outbreak never happens again and to make sure they are using the type of enforcement discretion necessary to preserve patients’ access to critical medicine.”
DeGette said, “The deadly fungal meningitis outbreak that sickened hundreds across the United States last year represented a tragic failure of the compounding drug manufacturing system and made clear we must have a stronger and more effective regulatory framework to oversee that system. That is why I was proud to join with my friends and colleagues Congressmen Griffith and Green earlier this month in introducing legislation that ultimately served as a foundation for the Drug Quality and Security Act introduced today. Today’s bipartisan, bicameral bill will take important steps forward to develop a more robust regulatory framework that can save people’s lives. I know my colleagues and I look forward to the passage of this bill and to continuing to work to ensure we take every step possible to secure the compounding drug manufacturing chain, and protect the lives of American patients.”