The track-and-trace provisions
that made it into the Senate version of the PDUFA legislation will
not make the final cut as the House and Senate versions are
reconciled, according to Bill Fletcher, serialisation specialist
and managing director of Pharma Logic Solutions.
This weekend (June 16-17) has been very active as legislators
considered updates to the User Fee Acts (UFA), including how to
implement a federal alternative to California Law for serialising
and tracing Rx drugs.
I have been actively seeking to simplify the cost and burden to
drug manufacturers and drug supply chain participants for securing
the US drug supply chain with pragmatic federal legislation to
preempt a patchwork of individual state laws. On June 6, I
spoke in the US Capital Building to a group of legislative staff,
FDA and others on how other industries secure their products and
how other countries are implementing drug traceability solutions.
This resulted in many reaching out to me last week and this weekend
for suggestions and review of proposed legislation.
I was told this morning (June 18) by multiple very reliable sources
that the reconciled text for the latest UFA Bill will NOT include
any track and trace statements or requirements and that the
California Law stands for now. The revised Bill is expected
later today and anyone interested can write me for a
copy.
Given the admirable activity from the industry participants in the
Prescription Drug Security Association (PDSA), and their RxTEC
labeling proposal (similar to Europe's EFPIA and Turkish encoding
requirements), and the momentum they have established, the group
will likely promote new proposals in the future.
The key concern from many was the lack of traceability in the PDSA
proposals at the lowest traded unit. Other industries, other
country drug tracking, and the extensively debated California Law,
all require unit level tracking and control. A common element
in requirements from other countries is the use of a state
controlled central registry and authentication at the point of
dispensing.
I also understand that the PDSA concerns over aggregating
serialised content to container, was trumped by the notion that
drug packaging is tightly controlled and procedures are validated
(GMP). Some said that if a manufacturer cannot reliably track
which serial numbers are in the case how can they be trusted to
ensure the correct product is in the bottle (ref recent Excedrin
recall).
The fact that many leading drug manufacturers and supply chain
organisations, including members of the PDSA, provided written
confirmation in 2008 that they would be ready for the California
Law by 2015 didn't help the cost or complexity argument from the
PDSA.
Another argument that did not seem to gain traction was the notion
that the cost to implement unit level tracking at every step in the
supply chain of custody was too expensive. The arguments
against this that seemed to get the most attention were (1) that
other unregulated industries track serialised units and aggregate
serialisation to containers for items costing far less than most Rx
drugs (i.e., integrated circuits and auto parts) and (2) that
because even if the cost per line is as much as $1m per line (line
costs plus amortised enterprise costs), that most Rx packaging
lines produce from several hundred thousand to a few million items
per year and that in that case a 1 year ROI would amount to about
$1 per item (and then pennies per item for maintenance after
that).
Since California Law stands for now and 2015 will be upon us in no
time, those waiting for PDSA may wish to consider their options and
how they will comply. Implementing serialisation and tracking
to comply with California and various country requirements can be
done far easier and less expensive than expected.
And finally, I remain concerned for my loved ones who depend on Rx
medications and the public outrage if there is unnecessary harm or
death due to a failure to act.
I hope this helps. Feel free to write
social@pharma-logic.com with
questions.
Bill Fletcher
Bill
Fletcher’s background spans over 29 years in pharmaceutical,
enterprise and supply chain software and healthcare systems.
He is currently focused on pharmaceutical serialisation, track and
trace and anti-counterfeiting for both commercial and clinical
goods. He has developed serialisation and e-Pedigree
strategy, requirements, vendor selection and project planning for
multiple companies. In May, 2012, he completed his 13th
serialisation and traceability project for global life sciences
companies, including multiple top 20 pharmaceutical manufacturers.
He is currently under retainer agreements with multiple leading
life sciences companies to provide subject matter expertise for
complying with global regulatory traceability, serialisation
requirements and planning the deployment of related technical
solutions.
Mr. Fletcher has spoken and published numerous times on issues
within the pharmaceutical industry. He is a member of several
industry advisory groups and as such has had an impact on guiding
the way organisations navigate the issues driving business
strategy.
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