The United States has one of the safest and most closely monitored pharmaceutical supply chains in the world. The U.S. Food and Drug Administration (FDA), which reviews and approves all prescription drugs, is responsible for the security of our prescription drugs and has long been a vigilant watchdog over unsafe, diverted and counterfeit drugs. Unfortunately, in recent years, the FDA has seen a significant increase in the number of counterfeit, unsafe and potentially lethal drugs entering our drug distribution system.
Some states have tried various approaches to ensure drug distribution integrity, but there remains a lack of consistency and connectivity to adequately protect patients and public health from unsafe drugs entering the supply chain. Gaps in state laws are forcing industry stakeholders to invest in expensive, disparate approaches instead of a national infrastructure that would serve all fifty states.
Recognizing the need for a federal law that establishes uniform standards for transaction histories of all drugs, Congress is stepping up this session to enact legislation. Both the House and Senate have introduced bipartisan bills that provide precise track and trace requirements for each stakeholder in the drug supply chain. These “pedigrees” require the authenticity of drugs to be verified by the responsible entity as the drug moves through the supply chain and to notify authorities of suspect or illegitimate products when they become aware of them.
The House bill, which amends the Federal Food and Drug Cosmetic Act (FDCA), passed the House on June 3rd. The bill requires specific track and trace requirements for prescription drug manufacturers, wholesalers, re-packagers, third-party logistics providers and dispensers (pharmacies).
The Senate bill, called the Drug Supply Chain Security Act, was passed out of the Senate Committee on Health, Education, Labor & Pensions (HELP) on May 22nd and is waiting for floor action. It is similar to the House bill but includes variations in the timing of implementation and requirements by some of the responsible entities.
Immediate action is needed. Without Congressional intervention, patients remain at risk for potentially dangerous or ineffective drugs landing in their medicine cabinets. National patient advocacy organizations are rallying behind the legislation and calling on their constituents to press their members of Congress to move forward with the establishment of national standards.
Players in the drug industry support stronger track and trace legislation, too. Tony Maddaluna, executive vice president at Pfizer and president of Global Supply, stated, “A national track and trace system would require that prescription drug products contain sophisticated technology able to determine the product’s source and distribution history and provide immediate protection. It also would give the FDA the nationwide authority to keep the system safe from bad actors and ensure an efficient and cost-effective system applicable in all 50 states.”
According to Jim Greenwood, president and CEO of BIO, which represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations, “Compliance with a federally established standard will be costly initially to our companies and the other affected stakeholders in the supply chain, but it is necessary to protect patient safety.”
To learn more about drug safety and track and trace legislation, go to the Pharmaceutical Distribution Security Alliance at www.pdsaonline.org .