WHAT THEY’RE SAYING: DRUG QUALITY AND SECURITY ACT
“This compromise legislation addresses the issues that led to the NECC tragedy, protects the physician-patient-pharmacist relationship, maintains critical patient access to compounded medications, and strengthens the pharmaceutical supply chain.” - NCPA
WASHINGTON, DC – Earlier this week, House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Senate HELP Committee Chairman Tom Harkin (D-IA) announced bipartisan, bicameral legislation to address high-risk drug compounding practices and strengthen America’s pharmaceutical supply chain. H.R. 3204 – the Drug Quality and Security Act – builds upon the Energy and Commerce Committee’s extensive efforts to improve drug safety and help prevent a future public health crisis like the 2012 meningitis outbreak tied to the New England Compounding Center.
In addition to the bill’s introduction, momentum continues to build around this important effort as dozens of groups have voiced their support. A sampling of the support is provided below:
“This compromise proposal provides a balanced and effective approach to address critical and complex issues surrounding compounded medications, as well as strengthening our nation’s pharmaceutical supply chain. NCPA applauds the House for moving this legislation in expeditious fashion, and urge members to vote in favor of this bipartisan compromise. … NCPA commends the Congress for crafting bipartisan legislation that addresses the New England Compounding Center (NECC) tragedy, ensures quality standards for all compounded pharmaceuticals, and maintains patient access to vital compounded medications.”
“Cancer patients and providers support a pharmaceutical distribution system that will protect against the counterfeit medicines that have put cancer patients at risk in the recent past. Distribution system protections should include traceability requirements, electronic unit-level product tracing standards, and a uniform national policy for drug distribution security. We are mindful of the challenges associated with protecting patients while also ensuring flexibility to supply-chain members as they work to meet the new distribution system requirements.”
“The Drug Quality and Security Act establishes a uniform standard for electronic prescription medicine tracking that will further safeguard our nation’s prescription drug supply. Americans deserve the predictability and reliability that this uniform federal standard will make possible.”
“After many years of debate, it appears that we finally have an opportunity to enact federal legislation to strengthen the security of the pharmaceutical supply chain. … This is the right approach to further strengthen our pharmaceutical supply chain, help ensure safe, efficient delivery of medicines and protect patients from threats associated with counterfeit and diverted products.”
“By strengthening the prescription drug supply chain, the Drug Quality and Security Act helps protect American families against counterfeit drugs, unnecessary cost increases, and drug shortages. It helps Perrigo, our Michigan-based manufacturing facilities and our employees, avoid millions of dollars’ worth of duplicative government regulation and red tape by imposing a nationally uniform system for tracking and tracing prescription drugs. This is a fine example of the Congress working in a bi-partisan fashion to come up with a sensible solution to a problem.”
“This bill will increase the security of the United States’ already strong drug supply chain by creating a national traceability system and replacing the patchwork of state laws now in place. Specifically, this bill provides greater safeguards for patients by requiring the placement of unique serial numbers on each drug package, and tracking them as they move through the distribution system, lessening the threat of illicit and counterfeit medicines entering the drug supply chain. For these reasons, the time is now to pass this bill.”
“UPS strongly supports the final passage of the Drug Quality and Security Act. UPS appreciates and applauds the House Energy and Commerce Committee’s work toward bi-partisan, bi-cameral legislation that will protect American consumers by creating a more secure pharmaceutical supply chain.”
To see a complete list of organization letters and statements on the committee’s efforts, click here.