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Facing such a furious rate of innovation, and so much medical data being collected outside formal clinical trials, is the regulatory system capable of keeping pace? Will the future of medicine be ungoverned?

The FDA’s Global Safety Net

Those who predict the FDA will be radically weakened in this future are dead wrong. Quite the opposite. The FDA’s global safety net plan will become the reality. The American FDA and its partner agencies will play the same role in medicine as the American military does in patrolling the world’s seas and skies.

Many people believe the FDA can’t possibly regulate rogue medicine around the world. They are overlooking the way the FDA is already building a fairly effective global trust network.

» Pharma companies desperately want a single international regulatory standard, predicting it could reduce development costs by 20%.

» Clinical trials are now distributed to sites internationally. More than half of all clinical sites are outside the US. This forces regulatory agencies to coordinate. Rather than being “rogue” incubators of fringe science, these international hospitals and universities all conform to American standards of good clinical practice to be eligible for inclusion in the trials.

» No trials are conducted without some US sites, and all the trial sites comply with the same standard as inside the US, and go through inspection and investigation.

» Through pacts, treaties and licensing deals, the US is bringing the world together. 143 international agreements are already in place among 43 nations.

» The FDA already asserts authority over 300,000 foreign facilities that ship to the US, and last year alone it inspected over 3,500 of them.

» The FDA already has to govern all the food products imported to the US. That’s some 37 million shipments a year. Their expertise in food will translate increasingly to drugs.

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