What You Need to Know about the FDA Approval Process
What you Need to Know about the FDA Approval Process
There are many misconceptions and misunderstandings about The Food and Drug Administration (FDA). Whenever a product is recalled or inflicts injury, people often wonder how an unsafe product can be allowed on the market. The truth is FDA approved or FDA cleared products do not necessarily mean they are universally safe.
What is the FDA?
The FDA is a federal agency whose mission is to protect the health and safety of the public by overseeing and evaluating products prior to being sold on the market. These types of products include, but are not limited to, food, tobacco, prescription and over-the-counter medications, medical devices, cosmetics, and products that emit radiation such as electronics. Manufacturers are responsible for conducting their own animal and human testing of the products to ensure the safeness and effectiveness of their said purpose while the FDA evaluates the scientific studies and determines if the benefits outweigh potential risks or harm. Thus, the FDA does not create products nor perform their own independent studies.
Is FDA approved and FDA cleared the same?
FDA approved and FDA cleared have two different meanings. FDA approval is when research studies of a pre-market product are evaluated and determined that the safeness and effectiveness are greater than the risks at hand. This is primarily required for drugs and medical devices that are designed to benefit or optimize one’s health, but also carry a considerable risk of illness or injury. Examples of products requiring FDA approval ranges from bandages to implantable medical devices such as pacemakers. On the other hand, FDA cleared is when a manufacturer can prove that their product is significantly similar to one that has been previously approved. The manufacturer demonstrates this by comparing the product’s design, features, and function to an already FDA approved product, therefore, it is inferred as equally safe and effective.
Downfalls to the FDA
While it is understandable that one may trust the credibility of a FDA approved or FDA cleared product, the approval process itself has pitfalls that may give a consumer a misrepresentation of its safeness. Any product that is FDA approved or FDA cleared does not ensure 100% safeness or effectiveness. In fact, many products have been recalled over time or were faced with lawsuits after causing harm or injury. One major issue is clinical trials performed by the manufacturers are typically short-term and have small focus groups which leaves no insight on the risks/harm for long-term use, and a small focus group may not be an ideal representation of the general public. Moreover, the clinical trials do not always take other risk factors into consideration. For example, it is unlikely that a newly approved medication underwent clinical testing to see how it may interact with other medications or ailments. This can cause extreme illness or injury resulting in hospitalization, permanent disability, or death. The FDA only evaluates the company’s research studies and does not perform its own testing of the product.
Secondly, as noted above, a product cleared by the FDA based on an existing product may be compared to a product that was recalled and still receive its clearance to sell.
Third, drug companies and manufacturers help fund the FDA. This could act as an incentive for the FDA to speed up their processes and approve products without a thorough review.
Lastly, the FDA cannot issue a recall; it is up to the manufacturer to take the steps of recalling its products. The FDA can only recommend a manufacturer to recall its product or issue a court order to try to force the manufacturer to recall its product.
Brown and Crouppen and FDA approved/cleared products
Our Mass Tort department represents those who have been injured by dangerous drugs and medical devices. We have litigated thousands upon thousands of cases against corporate giants whose products were once approved or cleared by the FDA. It is important to note that not all recalls warrant litigation and dangerous products continue to be sold each day without recalls. To name a few, Talcum Powder and IVC Filters are two types of product liability cases our firm has focused on in recent years.
- Talcum Powder is a soft mineral used in baby powders and falls under the category of cosmetics. We represent plaintiffs who have been diagnosed with ovarian cancer or fallopian tube cancer after using Johnson and Johnson’s extremely popular baby powder for hygiene purposes. On October 18, 2019, after decades of being on the shelves, Johnson and Johnson recalled the baby powder after testing revealed a presence of a known carcinogen called asbestos.
- IVC Filters are implantable medical devices used for those who are at risk of a Pulmonary Embolism or blood clot. We represent plaintiffs who have sustained significant injury after the filter fractured or migrated to other parts of the body. In August of 2010, the FDA issued a warning of this risk, however, IVC filters have yet to be recalled.
If you would like to learn more about harmful products and devices, contact us today for a free consultation.