In an article recently published in The Atlantic, a journalist posed the broad question of "What are the legal and regulatory adjustments that need to be made to shore up American standards - rather than have them slip to levels seen elsewhere around the world?" Specifically, the author explored the patient safety problem of dangerous and defective drugs and medical devices imported into the United States.
Poorly regulated production and lax safety standards abroad have contributed to an uptick in the number of unsafe drugs and devices imported into the U.S. Additionally, the Food and Drug Administration's resources are not yet properly structured to effectively counter all dangerous imports as well as unsafe domestic products that slip through cracks in the regulatory system.
Given that approximately 80 percent of active pharmaceutical ingredients are manufactured overseas (where safety regulations are far more lax than domestic ones), the FDA must adapt to this global marketplace or continue to risk the safety of the American public.
Though the FDA may soon be allowed to focus more of its resources on inspecting foreign drug manufacturing plants, this step is only one of many that should be taken in order to better protect patients from dangerous drugs and medical devices.
The FDA's regulatory framework has changed little since the agency was formed in the 1930's. It is almost exclusively equipped to handle domestic drug and device production, partially because the U.S. used to produce most of its own medicines and partially because it is easier to regulate domestic products effectively.
Though steps are being taken to address the increasingly global nature of the medical product market, much work has yet to be done to protect U.S. patients from dangerous imports.
Source: The Atlantic, "What It Really Takes to Change Washington," Steve Clemons, June 12, 2012
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