Pharmaceutical Commerce - June 2018 - 6
OV E RV I E W
Pharma traceability lumbers
A 2017 postponement makes 2018 the key year for serializing US products;
BY NICHOLAS BASTA
he modernization of the US drug supply chain is now halfway through the timeline set by
the Drug Supply Chain Security Act (DSCSA): it's been five years since the law was passed,
and in five years (if all goes according to plan) it will be (mostly) fully functional in 2023.
A ten-year implementation plan for a federal program is
It can help support innovative manufacturing and distribution
an unusually long gestation; the Prescription Drug User Act
technologies at a time when the drugs being developed are
(PDUFA), the program that organizes the payments industry
becoming increasingly tailored to specific patient populations.
makes to FDA for drug review, is a law with a roughly
Gottlieb is setting a high bar; there is evidence that
comparable impact on industry practices; it has a five-year
industry is having a difficult time achieving it. A 2016
span and gets Congressional reauthorization at the end of
survey of 67 suppliers (i.e., pharma manufacturers) by the
Healthcare Distribution Alliance found that about 51% of
Ever since DSCSA was passed in 2013, there has been
them expected to be ready for providing serialized product
offline jawboning that the law might be delayed indefinitely
by November 2018 (this was at a time when the official
into the future, or done away with as part of a Trump
deadline was November 2017)-which implies that 49%
Administration "deregulation" action.
So, there's large reassurance in FDA
In Europe, operating under
Administrator Scott Gottlieb's
the EU's Falsified Medicines
opening address, at an FDA public
Directive, the picture looks worse.
hearing in February:
A Februar y 2019 deadline for
chain must be our shared goal.
FDA and stakeholders have been
providing serialized data won't
working collaboratively toward
even see most EU members
full implementation of the Drug
having a national system in place.
Supply Chain Security Act in 2023. Reaching that milestone,
"Connecting to national traceability systems has proven
on time, is a high priority for us ... I know that reaching true
to be more complex than originally planned," says Mark
interoperability for systems and processes that can produce
Davison, sr. operations director for Europe at rfXcel, one
full information for each transaction going back to the
of the software vendors in the field. "And the problems
manufacturer - down to the individual package level, in near
we see now are only part of what we'll see next February."
real time - is challenging.
Some 40 other countries around the world, including China
... Seamless state-of-the-art security throughout the supply
and India, major suppliers to the rest of the world, have
chain must be our shared goal.
implementation schedules falling in the next few years.
He even looked ahead to the post-2023 scenario:
Under FMD, an "EU hub" has been set up, and companies
A fully digitized supply chain can also help develop
distributing into EU member countries are supposed to file
predictive analytics to reduce health care fraud, waste, and
their product serial data with that hub, which in turn directs
abuse. It can allow regulated industry and regulators to more
it to national hubs. Local pharmacies in each country are
easily manage or avoid costly or dangerous supply disruptions.
then supposed to verify product against this national hub.
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