Federal track-and-trace legislation shows a pulse

New effort to get US legislation passed seems about to begin

For several years running, each new session of Congress has had at least hearings on legislation to create a national standard for serializing pharma products and tracking their distribution to the point of dispensing; and each has failed even to get a full vote in either house. Now, the latest effort appears ready to start up: the Senate Education, Labor and Pensions committee, under Tom Harkins (D-IA) and with the support of ranking member Lamar Alexander (R-TN) has issued a discussion draft of a proposed law, and has given stakeholders (essentially, anyone) until April 26 to send comments on it to the committee, in care of: drugdistributionsecurity@help.senate.gov. There is also a hearing scheduled in the House Energy and Commerce committee on "Securing our Nation's Prescription Drug Supply Chain"--so it appears a coordinated Congressional effort is now under way.

The discussion draft follows a similar format to a draft issued last fall, although it appears that several of the open questions in that earlier draft have been resolved. In particular, while parts of the bill are to be in place by 270 days after its passage, the more arduous tasks (such as being able to verify the serialized code on a pharmaceutical package) don't kick in until four to seven years after passage, or in the 2017-2020 time frame--considerably later than the 2015 deadline for the beginning of the California e-pedigree program to be in force.

The Pharmaceutical Distribution Security Alliance (PDSA), a lobbying group made up of many parts of the overall US drug-distribution process, issued a statement applauding the Senate action, and noting that "this draft bill is an important step forward and demonstrates the commitment by many in Congress to enacting a supply chain solution now."