Angie Drakulich
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The US Food and Drug Administration has been sharing inspection information with its regulatory counterparts in the European
Union and Australia since last July as part of a pilot program under the federal Interagency Working Group on Import Safety.
Now, industry is forming an international pharmaceutical supply chain consortium known as Rx–360 to, among other objectives,
create a shared program for auditing suppliers.
The growing consortium is very similar to a model for third-party shared audits of active pharmaceutical ingredient suppliers
run by the European Chemical Industry Council's Active Pharmaceutical Ingredients Committee.
But is industry really willing to join in the sharing game? We're all taught to share from an early age, but somewhere along
the line, we get caught up in competition and slowly decrease our eagerness to confide in peers. Competition is important—it
is the foundation of our economy—and in the field of science, intellectual property rights and company proprietary information
require individuals to remain private about the details of their work. But perhaps this hiding of information has gone too
far. There must be a way industry can learn to share without giving up all its trade secrets.
Consider this: To meet all the new requirements for securing the supply chain, industry would have to conduct 800,000 audits
per year, said Rx-360's Martin Van Trieste at the June consortium launch meeting. Unless pharma firms are planning to go on
a massive hiring spree—perhaps alleviating the US unemployment rate along the way—to conduct these audits, it may be time
for industry to start sharing.
Angie Drakulich is the managing editor of Pharmaceutical Technology.
