The Food and Drug Administration, created in 1906, has been one of the most successful regulators in history—carrying out the monumentally complicated task of keeping America’s pantries and medicine cabinets free of harmful products even as the food and drug businesses have grown exponentially more complex. But as the drug business in particular has gone global in the past few decades, the FDA’s job has moved from extremely difficult to well-nigh impossible. Unless, of course, it can make some radical changes.
The drug business has been an international market for a very long time. Until recently, this has just meant that many of the most familiar drugs in your pharmacy have come from France or Switzerland—countries whose regulators work closely with the FDA. No one really worries about the quality of imported Canadian or European drugs, and the FDA is well positioned to inspect and certify those drugs.