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.Source found at http://www.bna.com/senators-release-draft-n17179873564/