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The FDA and Drug Approval

The United States Food and Drug Administration (FDA) is charged with ensuring the efficacy and safety of many different products, many of which are drugs and medical devices. Once a drug is approved by the FDA, consumers like to believe the drug is safe. Unfortunately, however, that is not always the case. You will often hear news reports about drugs being recalled or being issued a “black box warning,” (the most serious warning a drug can be given by the FDA before being recalled) even after receiving FDA approval. What many people may not realize is that the FDA is not responsible for conducting its own trials of the drugs it approves for sale.

In legal speak, the FDA was given legal authority by the Federal Food and Drug Act of 1938 to “review and approve new drugs for sale in the United States based on scientific support provided by the drug manufacturer as to the safety and efficacy of the drug or medical device.”

After testing a drug, the drug manufacturer sends the FDA an application known as a “New Drug Application.” If a review by the FDA’s physicians indicates the drug’s benefits outweigh the known risks, the drug is approved and marketed. When the FDA discovers that a drug maker has violated FDA regulations, the FDA will send a warning letter to the drug company identifying the violation(s) and orders the company to correct the problems. The FDA then follows up to make sure the corrections were made. If they were not, the drug could be recalled or be issued a black box warning.

The FDA is not responsible for creating the warning labels on medications; the pharmaceutical companies have this responsibility. The problem lies in the fact that sometimes, drug manufacturers do not fully comply with their obligations to ensure the products they put on shelves are safe and effective. When this responsibility is shirked, people can get very sick and die due to adverse effects from the drugs they were prescribed. When lives are lost or people are made seriously ill from dangerous drugs, lawsuits can be filed against the drug manufacturer and other parties involved in providing the drug to the victim.

Many claim there are problems with the FDA-approval process of drugs and medical devices. One major claim against the approval process is that drugs are often approved after only short clinical trials, which means that long-term effects of the drug cannot be detected. Drug companies are supposed to perform studies after the drug hits the market, but many of these companies simply do not follow through with these studies because the FDA has little power after a drug is approved.

The FDA approval process for drugs and medical devices is a complicated one that cannot possibly be explained fully here. To learn more about this process, please read our page FDA Approval Process & the Pharmaceutical Manufacturers.

If you or a loved one has been harmed by a dangerous drug, an experienced defective drug attorney can review your case and advise you of how to proceed. Please contact Schlichter, Bogard & Denton today to schedule a confidential consultation.

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