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After last year's fungal meningitis outbreak caused by the now defunct New England Compounding Center, lawmakers are taking a stand and working to prevent another devastating mistake. A new bill called the Drug Quality and Security Act has been introduced and it's winning bipartisan support because of the way it would allow the Food and Drug Administration (FDA) to track prescription drugs from manufacturing to distribution.
As of right now, compounding pharmacies are overseen by state pharmacy boards. Under the bill, compounding pharmacies can register as outsourcing facilities and be subject to oversight by the FDA, just like traditional drug manufacturers. They would also have the option to continue to run as a traditional pharmacy and keep being regulated by the state boards of pharmacy.
Individuals who back the bill say that it will help protect the safety of the compounded drugs and the nation's pharmaceutical supply chain. Federal regulators would be able to track what the compounding pharmacies are making, receive reports about problems with any of the compounded drugs, and have the authority to conduct safety inspections.
After New England Compounding Center killed at least 64 people and sickened 750 in 20 different states, this new legislation is a welcome development in protecting the safety of our nation's consumers. The legislation is expected to pass quickly and smoothly through the full House and Senate.
"This legislation is a major stride toward the goal of ensuring the quality and safety of the medicines Americans rely upon every day," said House Energy and Commerce Committee Ranking Member Henry A. Waxman in a statement.