Congress Moves Toward National Standard For Drug Product Tracing

As Congress attempts to find common ground on a national tracing system for pharmaceuticals, the supply chain is preparing for current serialization requirements in California and globally.
While the House of Representatives on June 3 passed its proposal for a federal standard for the supply chain, a draft bill approved last week by the Senate’s Health, Education, Labor, and Pensions Committee has earned strong support from stakeholders including patient and provider groups. The bill is expected to go to the full Senate for a vote this month.
At the Pharmapack North America conference and exhibition June 18-19 in Philadelphia, Virginia Herold, executive officer, California State Board of Pharmacy, will provide updates on government anti-counterfeiting legislation, and on the Board’s expectations for meeting the state’s pedigree law.
Peter Schmitt, managing associate, Montesino Associates LLC, will discuss common denominators among the various active global serialization standards.  Attendees will also hear presentations on serialization from companies including GS1-US, Pharma Logic Solutions LLC, and TraceLink, Inc.
The House and Senate bills differ in how they address a transition from interim requirements with lot -level tracking to unit-level tracking, as standard numerical identifiers are applied to saleable level packaging.
“The Senate bill creates a clear path to unit-level traceability in ten years. The House bill clearly never gets us to that point. There is no requirement to ever finalize (unit-level traceability),” says Allan Coukell, senior director of drugs and medical devices, The Pew Charitable Trusts.
“My hope is the House will recognize (that) the Senate has created draft after draft with a huge amount of stakeholder input  and has the support of all the major stakeholders,” Coukell says.
Coukell identified three key elements of a national system in submitted written testimony to the House Energy & Commerce Committee in April: participation by all members of the supply chain, traceability of drugs at the package level, and routine checking of drug serial numbers.
“We recognize the Senate committee was balancing a lot of interests. In an ideal world, we would have liked to see a shorter time line, and more routine verification of serial numbers.  In neither bill is there an explicit requirement for routine verification; (verification of SNIs) would depend on how the systems evolve and are constructed,” he adds.
The Senate bill has earned the support of the Senate California delegation,  expressed in a May 29 letter to the committee’s leaders and Senate leaders.
“We write today to express our gratitude to you and our colleagues in working so hard to address many of the concerns in S. 957, the Drug Supply Chain Security Act, and express our intention to support Senate passage of the bill, provided that no changes are made that weaken the unit-level drug distribution security system it puts in place in 10 years . . . .” wrote Sens. Barbara Boxer and Dianne Feinstein.
The Senators went on that, . . . “ we are concerned that the bill moving forward in the (House) would pre-empt strong state laws, including California’s, with a weaker federal standard.
“We join the California State Board of Pharmacy, Pew Charitable Trusts, and others in expressing concerns that the House’s proposed drug distribution security system fails to meet essential criteria in improving the integrity of our nation’s prescription drugs and in fact would leave consumers more vulnerable by preventing states from taking appropriate steps to protect their citizens.”
It remains to be seen if the Senate and House can bridge the differences between the two bills. House committee chairman Fred Upton has stated the goal of putting legislation on the president’s desk for signing by August.
--Dave Vaczek
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