BIO Praises Senate for Passing Single, Uniform and National Traceability System

[Update: President Obama signed H.R. 3204 into law on November 27, 2013]

WASHINGTON (November 18, 2013) – Today, the Biotechnology Industry Organization (BIO) applauds the Senate for approving H.R. 3204, the Drug Quality and Security Act, which will create a single, uniform and national solution to safeguard the nation’s pharmaceutical supply chain against criminal counterfeiting. The bill, which passed the House of Representatives on September 28th, now will be sent to President Obama to sign into law.

This legislation establishes uniform national standards for the supply chain, which will replace the currently fragmented and piecemeal system that varies from state to state. It strengthens the FDA’s ability to keep bad actors out of the system, and requires that prescription drug packaging use advanced technologies so a product’s source and distribution history can be traced nationwide from manufacturer to patient.

The following can be attributed to Jim Greenwood, BIO’s President and CEO:

“We believe this legislation will further strengthen the biopharmaceutical supply chain to protect patients from potentially counterfeit or adulterated drugs.

“We support the establishment of strong, uniform, scalable national standards for drug serialization and tracing systems contained in this legislation, rather than reliance on inconsistent state mandates.

“Today’s pharmaceutical distribution supply chain is governed largely by a patchwork of state laws and regulations that allows criminals to enter markets with the lowest safety requirements to inject counterfeit, unsafe, and potentially lethal products into the national supply chain.

“A single, uniform and national solution will help supply chain stakeholders avoid the costs and complexity of complying with a maze of contradictory laws, and ultimately protect consumers and patients across the country. Patients, physicians, and the pharmaceutical industry all have a vested interest in making sure that patients are getting products as prescribed.

“BIO thanks Senators Michael Bennet (D-CO) and Richard Burr (R-NC) and Representatives Bob Latta (R-OH) and Jim Matheson (D-UT) for sponsoring this important and timely legislation, and we also thank Chairmen Harkin and Upton, and Ranking Members Alexander and Waxman for all of their hard work in making this legislation possible.

“We will continue to work constructively with the Congress, FDA and our supply chain partners as we build a national system to prevent counterfeit medicines from reaching patients.”

Once President Obama signs the legislation into law, the FDA will need to undertake a number of administrative actions in the coming years.

For more information on the policy issues affecting the biotechnology industry, please visit www.bio.org. 

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