How the Medicine Testing Process Works
Whether it’s an over-the-counter medication or prescription drug, generally, every medicinal product has to go through various research stages and clinical testing before it is approved to be sold.
Yet, despite the fact that the U.S. Food and Drug Administration (FDA) plays a major role in this process, there are many instances where approved drugs end up being just as harmful to a patient as the condition they are trying to treat. If the pharmaceutical company that develops and designs a drug fails to give adequate warnings about any potential risks of using their product, you may be able to seek legal action against them.
For instance, Taxotere, a chemotherapy drug used primarily to treat breast cancer, has had some unexpected effects on patients. One of the major issues is permanent and irreversible tearing caused by the product.
The Texas Taxotere lawsuit attorneys of Hotze Runkle PLLC are here to give you a brief overview of exactly how the drug development process works, as well as information on factors that lead to defective drug product cases.
About the Medicine Testing Process
Discovery and Developmental Phase
Before a new drug is developed, market research is done first to ensure there is a need for it. This process usually includes a scientific investigation into the condition, as well as how it functions and spreads within the body. Once this portion is complete, the researchers will investigate exactly what tools (chemicals, compounds, etc.) might act on the specific disease.
During this phase, the research team will look for chemical compounds that will best treat the condition in a safe and effective manner. This includes determining the toxicity levels of the compounds and obtaining as much data as possible via multiple experiments.
The Clinical Trial Process
In order to properly test these drugs out, a protocol is created to organize the overall objectives, questions, and answers researchers are attempting to obtain. Some of the notable factors that must be decided upon before testing include:
- Who is eligible to participate in the study.
- The number of people who will be involved in the study.
- The time length of the research.
- If there would be a separate control group that will participate.
- How large of a dosage will be given to the participants.
Before officially starting the testing process, the developers must submit what is known as an Investigational New Drug (IND) application to the FDA. This application will give them the initial information of the product with all the details that must be secured.
The Phases of a Clinical Trial
If cleared to proceed with clinical testing, then 4 separate phases take place over extended periods of time.
- Phase 1: Involves a study with generally less than 100 people and is tested on either healthy volunteers or people living with a specific condition. This phase can last up to several months and it is meant to find out what the proper dosage for consumption will be. About 70 percent of drugs pass on to the next phase.
- Phase 2: This phase expands on the group size and only focuses on individuals who have a specific pre-existing condition or disease. This phase can last anywhere from several months to 2 years and is meant to determine the drug’s efficiency, as well as side effects. Only about 33 percent of drugs proceed to the next phase.
- Phase 3: This phase reaches an even larger group of volunteers who have a pre-existing condition or disease and can last anywhere from 1 to 4 years. The purpose of this phase is to not only continue evaluating the efficiency of the drugs but also monitor any long-term adverse reactions. Only about 25-30% of these drugs move to the final phase.
- Phase 4: The final phase involves several thousand volunteers who currently have the disease, and continues to monitor its safety and overall efficiency.
FDA Drug Approval
Once all the phases have been completed and it is proven that the given drug is safe to use and effective, the pharmaceutical developer can file a New Drug Application (NDA) with the FDA. The NDA reflects the overall research conducted on the drug and includes heavy detail, including clinical trial results, directions for use, safety information, side effects and abuse potential.
Once submitted, it can take 6 to 10 months for the FDA to make a final decision on whether or not the drug is safe to be sold. If there are any issues with the product, they must be resolved between the developer and the FDA. If any modifications are needed, the developer must file another application with the FDA.
The FDA will also overview the product’s labeling and marketing to make sure it complies with federal regulations. New drugs are generally protected from replications (i.e. generic versions) until their patent expiration date.
Defective Drug Claims
There are far too many cases in which developers are dishonest during the approval process. They may hide information from the FDA, provide false data, or even attempt to circumvent the process entirely through illegitimate means.
When it comes to holding pharmaceutical companies liable, there are generally three ways by which they can be found responsible:
- Improper labeling: Also known as failure-to-warn, essentially states that the developers did not properly label their drug as far as instructions, dosage, or listing risk factors when in use.
- Drug design defects: This refers to the initial design of a drug; failure to account for the entire makeup of the drug can lead to dangerous side effects that can lead to severe damages.
- Manufacturing defects: When a given drug is designed correctly but manufactured with defects, then a pharmaceutical manufacturer can be held responsible. This usually includes the drugs having tainted chemicals not originally included in the design.
Hotze Runkle PLLC, the Texas Taxotere Injury Lawyers You Can Depend On
If you or a loved one has suffered permanent tearing due to the defective chemotherapy drug Taxotere, do not hesitate to contact the Texas defective drug attorneys of Hotze Runkle PLLC.