How Does the FDA Decide When a Drug or Medical Product is Too Dangerous to Stay on the Market?

Originally published by robertslawfirm.

The Food and Drug Administration (FDA) is tasked with keeping the country safe by monitoring the safety and effectiveness of drugs, medical devices, food, cosmetics, and radioactive products. The FDA carries out this duty by creating rules and procedures to test medications and products before they are available to the public. While the FDA’s testing process is extensive, the agency cannot catch every dangerous drug or device, and sometimes hazardous products slip through. When it becomes clear that a medication or medical devices is too dangerous, the FDA can pull these products from the market. The decision to remove a medication or product is not taken lightly. Even if a drug’s risks outweigh its benefits, there may still be people who depend on that medication or product to survive. As a result, the FDA will only take a product off the market if there are safety issues that cannot be corrected, like serious side effects that were unknown when the medication was approved. Often, the FDA will take lesser steps before completely removing a product. The agency may require pharmaceutical manufacturers to add additional warning to the label of a medication, or can issue advice on when and how a product should be used. When these steps are not sufficient, the recall process begins. The FDA will issue a recall either at the request of the manufacturer, or on its own initiative. If the manufacturer refuses to recall the medication or product, the FDA has legal authority to force the […]

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