The FDA describes counterfeit drugs as those that may be contaminated or contain the wrong or no active ingredient, could have the right active ingredient but at the wrong dose, and could be harmful to your health. In testimony given before the House Energy & Commerce Subcommittee on Health this April, Dr. Janet Woodcock, Director of FDA’s Center for Drug Review and Evaluation said, “Counterfeit drugs raise significant public health concerns, because their safety and effectiveness are unknown. A counterfeit drug could contain a substance that is toxic to patients. But even a counterfeit drug with no active ingredient could prove harmful to patients who take it, thinking that they are taking a lifesaving or life-sustaining medication, when they are not.”
The pharmaceutical supply chain touches every part of the health care system from drug manufacturers, to wholesale distributors, to dispensers. This process involves multiple steps and numerous entities. In an effort to step up the safety of the supply chain, pharmaceutical companies agreed to report counterfeit drugs to the FDA on a voluntary basis starting in 2003. The industry, however, has since urged Congress to implement a national standard for securing the pharmaceutical distribution supply chain.
While pharmaceutical distribution occurs at a nationwide level, current standards for the pharmaceutical distribution supply chain vary by state, creating a patchwork of regulations. Exploiting the patchwork of laws, bad actors have infiltrated the supply chain, creating a business model that some experts have cited as even more lucrative than the trafficking of illegal drugs like heroin and cocaine.
Without Congressional action, a patchwork of unworkable state laws would be in place and add billions of dollars in potential regulatory costs to American manufacturers, distributors, and small businesses such as community pharmacies.
This May, I introduced H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013, a bipartisan bill to strengthen and secure our nation’s pharmaceutical distribution supply chain to protect American families against counterfeit pharmaceuticals. This legislation, cosponsored by Jim Matheson (D-Utah), is a result of collaboration and input from stakeholders throughout the pharmaceutical supply chain.
This bill will establish a national standard of tracing requirements for manufacturers, wholesale distributors, pharmacies and repackagers based on changes in ownership. Additionally, the bill establishes a collaborative, transparent process between the FDA and stakeholders to study ways to even further secure the pharmaceutical supply chain.
By replacing the current patchwork of multiple state laws with a uniform national standard we improve safety, eliminate duplicative regulations, and create certainty for members of the pharmaceutical supply chain.
With over 4 billion prescriptions filled each year in United States, it is of utmost importance that we implement commonsense solutions to safeguard our distribution supply chain to protect American families against counterfeit pharmaceuticals and improve security and integrity throughout.
Rep. Latta (R-Ohio) serves on the House Energy and Commerce Committee.