In response to last fall’s deadly fungal meningitis outbreak, House Energy and Commerce Committee Chairman Fred Upton, R-St. Joseph, praised a bipartisan agreement that was reached between the House and Senate on legislation to help ensure the safety of compounded drugs and our nation’s pharmaceutical supply chain. The legislation, the Drug Quality and Security Act, follows an extensive investigation led by Upton’s Committee into the cause of the public health catastrophe, which has infected 750 individuals and left 64 dead nationwide. By all accounts, Michigan families have been hardest hit by the contamination, totaling 264 cases and 19 deaths, including 3 fatalities from Upton’s own district.

“To the families who have lost loved ones and to those patients who continue to suffer, we say ‘never again,’” said Upton.

“This legislation is a major step forward to protect the public health and safety of the American people. It has been nearly one year since the tragic, deadly fungal meningitis outbreak and I am pleased to be working with my colleagues in the Senate to send a bill to the President’s desk, bringing this investigative and legislative effort to a successful conclusion soon.”

The bill clarifies current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation by applying a uniform standard nationwide.

Under the Drug Quality and Security Act, compounders who wish can register as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be regulated primarily by state boards of pharmacy, as they are in current law.  Outsourcing facilities would be subject to oversight by the U.S. Food and Drug Administration (FDA) in much the same way as traditional manufacturers are monitored.  FDA will know who these outsourcers are and what they are making, receive adverse event reports about compounded drugs, and have the authority and resources to conduct risk-based inspections.

"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, its Michigan-based manufacturing facilities and 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,” said Joseph C. Papa, President, Chief Executive Officer, and Chairman of Allegan employer Perrigo.

“This is a fine example of the Congress working in a bi-partisan fashion to come up with a sensible solution to a problem. We commend Congressman Upton for his outstanding leadership on this issue to further enhance patient safety."

The second title of the bill would replace today’s patchwork of state prescription-drug tracing laws by creating a new uniform framework for tracking drugs from the manufacturer to the pharmacy. There is currently no system for tracking the drugs that make up some four billion prescriptions per year in the United States, which means drugs that are stolen or counterfeit may not be discovered before reaching consumers.

“Pfizer appreciates the leadership of Chairman Upton and his colleagues in the House and Senate to pass the bipartisan bill designed to secure the pharmaceutical supply chain,” said Tony Maddaluna, Executive Vice-President and President of Pfizer Global Supply, which employs thousands of workers in Kalamazoo County.

“Patient safety is our top priority and this legislation will greatly enhance the security of the pharmaceutical supply chain.” 

A recently-released report from the nonpartisan Government Accountability Office (GAO) confirmed that legislation is needed to clarify the FDA oversight of large-scale drug compounders. The nonpartisan office wrote that “this lack of consensus and differing FDA authority to oversee compounded drugs across the country has resulted in gaps in oversight of drug compounding,” posing a grave threat to public health.