Worldwide Regulation of Medications

Prescription medications are regulated strictly by the FDA in the United States, and over-the-counter medications are regulated to a lesser extent.

Regulation of prescription medications is more lax in nearly all other countries compared to the United States. If a medication does not have major side effects, most European regulatory bodies will approve it as a prescription medication even if it hasn't been firmly proven to work in treating the illness.

Alternative medications are not regulated by the FDA, but they are lightly regulated in a few countries.

These differences explain why a number of medications available in European and Latin American countries, including Mexico, are not available in the United States. Several medications that are approved in European countries—for example, nimodipine, which is used to treat vascular disease in the brain and is prescribed for dementia by many doctors—have failed to show superiority over placebo in American clinical studies conducted according to more stringent FDA standards. Germany regulates alternative medications, which places it a step ahead of the United States in this area. Talk of uniform international regulations has been making the rounds for decades, but no country has been willing to give up its prize turf in controlling the manufacture and flow of these money-making drugs. It is easier to generate a common Euro currency than to create a single regulatory body to approve new medications for all countries in the European Union.

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