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

How Does the FDA Decide When a Drug or Medical Product is Too Dangerous to Stay on the Market?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 manufacturer to comply with its request.

The FDA has three classes of recalls. Class I is for the most dangerous products, and a Class II Recall is issued when there is a reasonable probability that the use of a product will cause serious adverse health consequences and/or death. Class III Recalls are the least serious, and are issued when the products are “not likely” to cause adverse health consequences. Most recalls fall somewhere in the middle of Class II.

Many of these recalls are the result of insufficient testing before the medication or medical device is approved. When the FDA or pharmaceutical companies fail to complete the required clinic trials, lie about the results of trials, or use the FDA’s fast-track system to push an untested medication into the market, people can get hurt.

If you have suffered injuries from an unsafe or defective medical product, the experienced product liability legal team at Roberts & Roberts is here to help with compassionate, aggressive representation. Please call 800-248-6000 or contact us for a free consultation.

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