Senators Release Draft Bill to Create National Drug Track-and-Trace System

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By Bronwyn Mixter  

 

Members of the Senate Health, Education, Labor, and Pensions (HELP) Committee April 19 released a discussion draft of a bill that would create a national traceability system for pharmaceuticals.

Sens. Michael Bennet (D-Colo.), Richard Burr (R-N.C.), Tom Harkin (D-Iowa), and Lamar Alexander (R-Tenn.) said in a press release that their draft bill would improve patient safety by replacing the “patchwork of state product tracing laws with a strong, uniform standard that would ultimately result in electronic, interoperable unit level product tracing for the entire country.” Harkin is chairman of the HELP Committee and Alexander is the ranking member.

“Ensuring the integrity and security of our prescription drug distribution system is critically important. To ensure consumers know that the medications they take are safe--not adulterated, counterfeit, or otherwise compromised, it is important to know where these drugs have been at every step of the way--from the manufacturer to the pharmacy,” Harkin said. “There is bipartisan consensus that we must improve the oversight of our prescription drug supply chain. This draft legislation reflects the work of Senators Bennet, Burr, and Alexander, along with my office, and I look forward to seeking further input as we move towards a final bill for introduction and Committee consideration.”

Track-and-trace provisions were taken out of the Food and Drug Administration user fees bill before it was passed by the Senate in 2012. At that time, Burr, Bennet, and Harkin said they would continue to work to get a track-and-trace bill passed.

This legislation does not deal with safety issues at compounding pharmacies, the senators said. The HELP Committee expects to release draft legislation on compounding “sometime” this week, they said.

Meanwhile, the House Energy and Commerce Committee has scheduled an April 25 hearing on the topic of securing the prescription drug supply chain.

Supply Chain

The draft Senate bill would require moving from a lot-level tracing system to a unit-level tracing system over the course of a decade, the senators said. It would require the entire drug supply chain, including manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers, to pass along transaction information, transaction history, and transaction statements, as applicable, when there is a change of ownership. Additionally, no one in the supply chain would be allowed to accept drugs if this information is not provided as part of a transaction, they said.

The proposal also strengthens licensure requirements for wholesale distributors and requires FDA to keep a database of wholesale distributors that will be available to the public on FDA's website, the senators said. “This empowers both consumers and members of the pharmaceutical distribution supply chain to identify appropriately licensed wholesalers,” they said.

The senators said they are asking stakeholders to provide feedback, including their level of support for the overall proposal, in addition to any comments regarding the feasibility of this framework, and any technical feedback to help improve the draft bill.

Comments on the draft bill are due April 26, the senators said. Comments may be sent to drugdistributionsecurity@help.senate.gov. A spokesman for Bennet told BNA April 22 that the senators hope to introduce the bill “soon.”

In October 2012, the Senate HELP Committee released a similar discussion draft bill for a national drug traceability system.

Stakeholders Respond

The Pharmaceutical Distribution Security Alliance (PDSA) April 19 applauded the senators for moving forward with the draft legislation. PDSA is a coalition of more than 25 stakeholders spanning the supply chain spectrum, including biopharmaceutical manufacturers, distributors, pharmacies, and logistics providers. The Pharmaceutical Research and Manufacturers of America (PhRMA) is a member of PDSA.

“We commend this bipartisan commitment to better protecting American patients and consumers through a single, uniform and national pharmaceutical distribution supply chain solution, and we are encouraged by this latest development,” PDSA said in a statement. “The release of this draft bill is an important step forward and demonstrates the commitment by many in Congress to enacting a supply chain solution now.”

PDSA said it “looks forward to thoroughly reviewing this draft and to working with lawmakers and other stakeholders to protect the health of patients and consumers by further safeguarding the pharmaceutical distribution supply chain.”


The draft bill is at http://www.help.senate.gov/imo/media/TAM13064.pdf.