Contact: Giselle Barry (Markey) 2022242742

Lawmaker was first to introduce legislation in House of Representatives at outset of deadly meningitis outbreak caused by compounded drugs manufactured in Mass.

 

Washington (November 18, 2013) - More than a year after the deadly meningitis outbreak that exposed the dangers of the unregulated compounding pharmaceutical industry, Senator Edward J. Markey (DMass.) praised today's passage of the Drug Quality and Security Act, bipartisan legislation that would provide greater oversight authority to the Food and Drug Administration (FDA) over high volume sterile compounding pharmacies. Tainted injectable steroids compounded at the New England Compounding Company (NECC) in Framingham, in Sen. Markey's former congressional district, triggered a deadly meningitis outbreak resulting in the deaths of at least 64 people.

 

The new legislation would help ensure the safety of sterile compounded drugs and would track and trace all prescription drugs from the manufacturer to the pharmacy. Many of the compounding provisions of the bill reflect Senator Markey's House legislation, the VALID Compounding Act, including putting limits on the type and quality of ingredients that can be used to compound drugs, disallowing compounded drugs that have been recalled or drugs that are found by the FDA to be too difficult to compound, and requiring compounders to comply with labeling and adverse event reporting requirements. The bipartisan Senate bill also includes specific language authored by Senator Markey directing the Government Accountability Office to conduct a study of pharmacy compounding after enactment of the new law to identify gaps in oversight by states and the FDA. 

 

"For the first time, hospitals and healthcare facilities will have access to safer compounded drugs that are subject to rigorous FDA standards and oversight," said Senator Markey. "Since day one of the tragic outbreak that originated in my Congressional district, I have led the investigation into manufacturers that were masquerading as pharmacies and putting the public at risk. This bill will go a long way to ensure that public health is protected and compounded drugs are safe. I commend Senators Harkin, Alexander, Franken, and Roberts for their leadership on this legislation and this issue. I will continue to monitor the FDA and this industry, holding them accountable and helping to ensure full implementation of this law." 

 

Video of Senator Markey speaking on the Senate floor in support of the legislation and his work on compounding pharmacy oversight can be found HERE . 

 

In the House of Representatives, Senator Markey introduced the VALID Compounding Act to strengthen federal regulations for compounding pharmacies, especially highrisk sterile compounding and compounding pharmacies that ship drugs across state lines. 

 

In April 2013, Markey led an investigation with other members of the House Energy and Commerce Committee that found that compounding pharmacies go largely untracked, unregulated, and underinspected by states across America, demonstrating the need for more federal oversight of the industry.