Understanding FDA Drug Regulation
While the U.S. Food and Drug Administration (FDA) has protocols in place to ensure Americans are safe from harmful drugs, many prescription and over-the-counter medications still get the stamp of approval and make their way to the market. You may be wondering, “How does this happen?” The answer is complicated. Here’s a breakdown of what you need to know to stay safe.
The FDA Approval Process
Before any drug can be marketed and sold, the manufacturer must get FDA approval and demonstrate that the drug is safe and effective according to FDA regulations. As per the Federation of American Scientists (FAS), the following are steps in the FDA drug approval process:
- FDA inspection - The manufacturing plant must pass this inspection.
- Drug labeling - Manufacturers must obtain FDA approval on:
- Written materials
- Prescribing information for doctors
- Patient brochures
- Clinical trials - After the manufacturer demonstrates safety through animal testing, a small number of human volunteers may begin the testing process.
- New drug application (NDA) - Once clinical trials are complete, the manufacturer must submit a new drug application to the FDA’s Center for Drug Evaluation and Research (CDER). It must include mandatory information detailing the following: manufacturing process, quality control and assurance procedures, and what the drug will be able to treat.
How Unsafe FDA Approved Drugs Make It to the Market
According to a study published by the Journal of the American Medical Association (JAMA), 32% of drugs approved by the FDA between 2001 and 2010 had some safety problems after reaching the market. The study also suggests that deadlines for the FDA’s regulatory review process may impact postmarket safety.
For example, in 1988, the FDA implemented the “Fast Track” program. In 1992, it created an accelerated approval process to allow drugs to move forward with data from as early as the clinical trial level — specifically for drugs needed to treat life-threatening and severe illnesses.
Top FDA Approved Drugs and Related Lawsuits
- Elmiron®: A prescription medication used to treat interstitial cystitis, a painful bladder condition. Despite the strong link between Elmiron® and degenerative eye conditions, it’s still on the market.
- Zantac®: This popular over-the-counter treatment for heartburn has been linked to many different cancers such as stomach cancer, colorectal cancer, and small intestine cancer. This product has been recalled and is no longer available to consumers.
- Uloric®: This medication used to treat gout has been linked to cardiovascular problems, including heart attacks and strokes — and deaths relating to these events. Despite the risk of death, this product is still on the market. The FDA has mandated that the prescribing information has a black box warning stating the increased risk of death.
Determining Liability in Harmful Drug Lawsuits
When it comes to product liability cases, determining who is liable can be tricky, and many different parties may be included, such as:
- The pharmaceutical company/manufacturer
- The testing laboratory
- The pharmacy where you received your prescription
- The doctor who prescribed the medication
- The hospital or clinic where your doctor is employed
When it comes to dangerous drug lawsuits, an experienced attorney will examine your particular case variables to determine who should be named liable in your lawsuit.
Harmed by a Dangerous Drug? We Can Help
When you have been prescribed medication or purchase an over-the-counter drug, you expect that it will help you recover from an illness and relieve symptoms — but when an FDA approved drug causes harm instead of healing, the consequences can be devastating.
If a dangerous drug has harmed you or a loved one, we are here to help. Attorney Mark Tate has been practicing law for over 20 years. Our renowned personal injury attorney team is here to help you seek justice and receive the maximum compensation that you deserve.