U.S. Food and Drug Administration

Many Americans have been buying prescription drugs from foreign countries as a way to cut costs, but experts at the Food and Drug Administration warn that this practice comes with potential safety risks. The safety and effectiveness of imported drugs have not been reviewed by the FDA, and their identity and potency can’t be assured. Patients could get the wrong drug. Or they could get too little or too much of the right drug. All of these differences can be dangerous.

“When Americans import medicines illegally or buy medicines online from unreliable sources, they are faced with a dangerous buyer-beware situation,” says FDA Commissioner Lester Crawford, D.V.M., Ph.D. “The FDA understands why people who are having a hard time paying for prescription drugs might do this. We have been expanding our generic drug program to help make more affordable prescription drugs available. This is one solution that does not put consumers at risk.”

The FDA doesn’t regulate drug prices, but agency experts recognize that the inability to access needed medication because of high prices is a serious public health issue. For this reason, the FDA has enhanced the process for the review and approval of generic drugs, and has taken steps to eliminate roadblocks that keep generics off the market. In 2004, the FDA approved 413 generic drugs, 320 full approvals and 93 tentative approvals. In 1999, the agency approved 266 generic drugs, 198 and 68, respectively. Tentative approval means that the product meets the FDA’s standards, but can’t yet be marketed because of existing patents or temporary government restrictions against competing products.

Generic drugs have exactly the same active ingredients and effects as brand-name drugs, but they can cost 30 percent to 80 percent less.

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