Today, Congressman John D. Dingell (D-MI12) commended House passage of H.R. 3204, the Drug Quality and Security Act, bipartisan legislation Dingell introduced alongside House Committee on Energy and Commerce Chairman Fred Upton (R-MI06) to help ensure the safety of compounded drugs and our nation's pharmaceutical supply chain.
Michigan was among the hardest hit by last year's fungal meningitis outbreak, caused by contaminated pharmaceuticals. Dingell's legislation reflects a bipartisan, bicameral agreement with the Senate Health, Education, Labor, and Pensions (HELP) Committee leadership to prevent future tragedies of this kind.
"This legislation is a big step forward in securing our pharmaceutical supply chain and improving FDA's authority to oversee compounding pharmacies," said Rep. Dingell. "Just one year ago, Michigan was hit especially hard by the fungal meningitis outbreak from the New England Compounding Center, with more than 260 cases and 19 deaths. The Drug Quality and Security Act clarifies the FDA's authority to oversee compounding pharmacies by removing the unconstitutional advertising provision and creating a new, voluntary structure for FDA to ensure large scale outsourcing facilities are meeting high quality standards."
The bill clarifies current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation by applying a uniform standard nationwide.
"For the first time our nation will have a uniform system to trace pharmaceuticals as they move from manufacturers to pharmacies, which will help prevent fraud," added Dingell. "This bipartisan bill is an important step to improve public health and keep our people safe, and I hope it quickly becomes law. I want to thank Chairman Upton, Ranking Member Waxman, and Representatives Pallone, Green, DeGette and Matheson for their hard work on this critical legislation."
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.
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.