Pharmaceutical liability refers to legal theories and ways to prove that the manufacturer of a prescription drug, over-the-counter medication, dietary supplement or herbal remedy may be responsible when the drug causes injury or death. The Food and Drug Administration ("FDA") is the government agency that is responsible for ensuring that our drug supply is safe and effective. Approval of prescription drugs is the job of the FDA’s Center for Drug Evaluation and Research ("CDER").Since 1938, every new drug has been the subject of an approved New Drug Application ("NDA") before U.S. commercialization. The NDA is the mechanism by which drug sponsors formally propose to the FDA that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug become part of the NDA. The FDA reviews the medication and may approve it for sale, but the FDA does not guarantee drug safety.
The purpose of the NDA is to provide enough information to permit the FDA reviewer to reach the following key decisions:
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Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
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Whether the drug’s proposed labeling or package insert is appropriate, and what it should contain.
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Whether the methods used to manufacture the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.
The NDA documents the drug’s history including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged. After the FDA approves a drug for a particular use, patients who are injured by the drug must look to the manufacturer for redress, whether the drug is used for its approved purpose or for some other reason (known as "off-label" use). Manufacturers will sometimes try to persuade a jury that, because the FDA approved the medication, the manufacturer should not be liable for any injuries the medication caused, particularly in cases of "off-label" use.
In some instances, a company discovers that one of its products is defective and has the potential to cause injury, pain or death. The company may recall the drug entirely on its own. In others instances, the FDA informs a company of findings that one of its products is defective and suggests or requests a recall. Usually, the company will comply. If the firm does not recall the product, then FDA can seek legal action. FDA actions may include seizure of the available drug, and/or an injunction against the firm, and a court order for recall of the product.
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