Regulation and The FDA

FDA Regulation of Potentially Dangerous Products

The Agency’s Responsibility to Consumers

The attorneys at Spangenberg Shibley & Liber LLP have proven experience trying cases involving dangerous products. The Food and Drug Administration (FDA) is a United States government agency that is responsible for protecting public health and welfare by ensuring that pharmaceutical drugs, medical devices, and certain other products are safe and effective. This oversight applies to products prescribed and distributed in Ohio and throughout the U.S.

What Products Are the Regulated by the FDA?

The FDA regulates and approves human drugs, vaccines, blood products and other biologics, and medical devices after appropriate testing is completed by the manufacturer. In addition, the FDA also regulates most foods other than meat and poultry products (including food additives, infant formulas, and dietary supplements); electronic products that give off radiation; cosmetics; feed, drugs, and devices used on animals; and tobacco products. All of these products have the potential to be dangerous if they do not comply with FDA regulations or if they are approved based upon false or incomplete information, which may constitute fraud. There are also some products that are offered for sale without FDA approval, such as dietary supplements, which may be dangerous or cause injury.

The Responsibilities of Manufacturers

The FDA approves new drugs and medical devices based upon the scientific information provided to it by manufacturers and does not conduct its own testing before approving a product. The FDA also does not guarantee the safety of drugs and medical devices. This means that the ultimate responsibility for the safety of a drug or medical device lies with the manufacturer. The drug or medical device manufacturer is responsible for ensuring that thorough testing is completed prior to selling a product, providing appropriate warnings, and making sure that any necessary changes are made if new information or risks are discovered. If the manufacturer is negligent in its testing or commits fraud in its application for FDA approval, you may be unknowingly exposed to a dangerous product.

Manufacturers and health care providers may voluntarily report problems with drugs and medical devices to the FDA. The FDA monitors the adverse effects that are reported, and these reports may lead to safety alerts and recalls. Not all adverse effects are reported, though, so FDA supervision is often not enough to protect the public from dangerous products.

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