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Do You Understand The Pharmaceutical Approval Process?

May 10, 2020
Colson Hicks Eidson

The award-winning product liability attorneys at Colson Hicks Eidson have a long and proud history of helping clients who have been injured due to negligent prescription drug companies. We recently filed a lawsuit on behalf of a client who has taken Elmiron for the treatment of interstitial cystitis and has subsequently sustained permanent eye damage. However, we realize that many people may not realize how prescription drugs are approved before they are allowed to be sold to consumers. Here, we want to discuss the approval process and what you can do if you think you have been harmed by a defective prescription drug.

How do prescription drugs get approved?

Every prescription drug sold in the United States must be approved by the US Food and Drug Administration (FDA). The FDA’s Center for Drug Evaluation and Research (CDER) ensures that both brand name and generic drugs work correctly and that their health benefits outweigh the known risks.

Before any drug company can sell a drug in the United States, the medication must be tested first. The pharmaceutical companies will then send the CDER evidence from their tests to prove the drug is safe and effective. At the CDER, A team of physicians, pharmacologists, chemists, statisticians, and other scientists will review the company’s data and the proposed labeling. If these experts establish that the drug’s benefits outweigh the risks, the drug will be approved for sale.

Before a prescription drug can be tested in people, the company must perform laboratory tests and animal tests to discover how the drug works and whether it is likely to be safe and work well in humans. After those tests, a series of trials in people begin which will determine whether the drug is safe when used to treat the intended disease or health condition.

How do faulty drugs get through the cracks?

Please note that the FDA does not do any testing of their own of the drugs or medical devices that they approve. They rely 100% on the data provided by the manufacturers to determine whether or not that prescription drug will be approved. There are several ways that faulty prescription drugs may make it to the market. In the past, pharmaceutical companies have:

  • Falsified and manipulated studies
  • Misled the FDA into thinking that the drug is similar to previously approved drugs when it is not
  • Discovered defects or dangerous side effects after a drug is released and failing to warn the FDA or take any other action
  • Improperly manufactured a drug or allowed contaminants to enter into the product
  • Failed to properly instruct consumers of how to use or administer the drug
  • Failed to provide proper warnings of the side effects of the drug
  • Used false advertising to promote the drug

Let us get to work on your behalf

If you or somebody you love has been injured or become ill due to defective prescription medication, the nationally recognized product liability attorneys at Colson Hicks Eidson are ready to get to work on your behalf. Our goal is to secure the compensation victims in these cases deserve. This can include coverage of their medical expenses, lost wages, and benefits, pain and suffering damages, as well as punitive damages. Whether you are in Florida or anywhere in the United States, we are ready to help. You can contact us for a free consultation by clicking here or by calling us at 305-476-7400.