Regulatory Focus™ > News Articles > Report: Track and Trace Negotiations Resume in Congress

Report: Track and Trace Negotiations Resume in Congress

Posted 10 August 2012 | By

Track-and-trace is dead; long live track-and-trace.

Politico reports staff members associated with the House Energy and Commerce (E&C) Subcommittee on Health and the Senate Health, Education, Labor and Pensions (HELP) Committee are meeting over the August congressional recess to restart stalled negotiations over pharmaceutical track-and-trace provisions.

Track-and-trace refers to a system by which regulators and pharmaceutical companies can track the movement of pharmaceutical products through the supply chain and trace products back to their point of origin if problems are discovered.

A measure to accomplish just that was left out of a sprawling piece of reform legislation known as the Food and Drug Administration Safety and Innovation Act (FDASIA) after congressmen were unable to sort out the particulars of the program and who should pay for it.

An 18 June report by Reuters indicated a bill containing only the track-and-trace provisions is expected to be reintroduced later in the year, and Politico's report seems to indicate the presence of some sustained momentum and enthusiasm to accomplish just that.

The next problem: How do you get a piece of potentially controversial legislation through the Congress? Politico notes legislators are looking to use a reauthorization bill for the Pandemic and All Hazards Preparedness Act to move the bill forward, but it's far from certain to be the final vehicle.

Potential Policy Obstacles

Far more important will likely be the policy itself. Congressional negotiations broke down over three distinct issues in June. The first regarded the level of product tracking, and whether they should be identifiable on an individual package basis or on a less precise but cheaper lot-level basis. Industry has favored the cheaper lot-level identification measures, while consumer advocates and many Democrats are in favor of the unit-level provisions.

The second hangup: Who pays for the plan? Some in Congress have called for the entirety of the costs to fall on the pharmaceutical industry, while the industry has been pushing for costs to be borne by the government.

A third issue before negotiators was the speed at which information about the products would be made available. Industry favored a serialization plan involving barcodes and databases, while some in Congress and the US Food and Drug Administration favored a real-time system.

Congressional Support and Opposition

Regardless of the minor points, the rebirth of the legislation seems to indicate legislators are on board with the basic tenets of the plan. A June 2012 report from Sen. Jay Rockefeller (D-WV) and Rep. Elijiah Cummings (D-MD) said track-and-trace provisions were a cornerstone of any attempt to secure the pharmaceutical supply chain. Sen. Richard Burr (R-NC) spoke for nearly two hours during debate over the FDASIA legislation, blasting his colleagues and lamenting the absence of the track-and-trace measures.

Neither, added Burr at the time, would it be easy to accomplish the measures in future legislative sessions. "It may be tougher then because this was a vehicle that had to go," Burr said, referring to the inclusion of important measures within FDASIA. "Therefore people would have swallowed a lot more."

It remains unclear whether the new bill would come to the floor after the conclusion of the August congressional recess, or whether it would be put on hold until after the 2012 Presidential election-or later.

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