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How does the FDA decide which medications are safe?

Pharmaceuticals are a billion-dollar industry in the U.S., as millions of consumers take prescription and over-the-counter medicine to combat everything from the flu to heart disease, diabetes and cancer. But before a new drug can hit the American market, its developer must first get approval from the Food and Drug Administration.

Specifically, the FDA judges pharmaceuticals for possible approval through its Center for Drug Evaluation and Research, or CDER. On its website, the FDA describes CDER’s duties as evaluating new drugs and advising patients and health care providers on safe use of approved drugs.

CDER does not actually test new drugs itself, besides some research into drug quality, safety and effectiveness standards. Instead, it puts the burden on the drug company to test its proposed product for safety and effectiveness. Such testing begins in the laboratory, progresses to testing on animals, and finally to human trials.

After testing, the company sends its findings to CDER. From there, a group of scientists including physicians, statisticians, chemists and pharmacologists review the data, as well as any labeling language the pharmaceutical company proposes.

The standard this team uses is whether the drug’s health benefits outweigh its known risks, which might include potentially damaging side effects or allergic reactions. If they do, the center approves the drug.

Ideally, this would mean that every medication on the market is reasonably safe for its intended use. Of course, in the real world drugs regularly are subjected to recalls. Sometimes, this is due to a manufacturing error, but other time previously unexpected side effects emerge that put the public at grave risk.

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