When many people hear “FDA-approved” or “FDA seal of approval,” they often think of a perfectly safe, well-tested product. Unfortunately, this is not always the case. We expect both prescription and over-the-counter products to keep us healthy and safe, but some products produce dangerous side effects due to poor labeling or unforeseen defects. Taking defective drugs or using defective medical devices causes a large number of people every year to suffer unfortunate injuries. So, what does FDA approved mean, and how can that label affect your case?
At Reich & Binstock, our Houston pharmaceutical litigation attorneys work day in and day out on behalf of our clients. Whether you were hurt because of inadequate labeling, misleading information, or some other mishap, we’re here to represent you against big pharma companies. If you or someone you love suffered injuries as a result of using defective drugs or medical devices, you need the attorneys at Reich & Binstock in Houston. For your free, no-obligation consultation, please call 713-622-7271.
What Is the FDA and What Do They Do?
The FDA, or the U.S. Food and Drug Administration, is a pivotal federal agency operating under the Department of Health and Human Services in the United States. Established in 1906, its core mission revolves around safeguarding public health by regulating and overseeing many products crucial to daily life. This encompasses various goods, including food, drugs, medical devices, vaccines, cosmetics, and tobacco products.
One of the FDA’s primary functions is ensuring food safety. It sets and enforces stringent standards for food products, additives, and dietary supplements. It meticulously monitors labels to protect consumers from contamination and potential health hazards.
In the realm of drug regulation, the FDA plays a pivotal role in evaluating and approving new drugs. This involves rigorous assessment during preclinical and clinical trials to guarantee the safety, effectiveness, and quality of pharmaceuticals before they can be brought to market.
Medical devices are also under the FDA’s purview, from simple instruments to complex machinery. The agency rigorously evaluates these devices to ensure their safety and effectiveness in meeting their intended purposes.
Furthermore, the FDA scrutinizes vaccines, blood products, and other biologics to ascertain their safety, purity, and potency. This is essential for safeguarding public health. Its oversight also extends to the cosmetics and personal care industry, monitoring these products’ safety for consumer use.
Through rigorous inspections, investigations, and enforcement actions, the FDA upholds regulations, aiming to ensure compliance and mitigate risks associated with various products. Overall, the FDA’s multifaceted role encompasses regulation, research, guidance, and public education. They are crucial in promoting and protecting public health in the United States.
What Products Must Be FDA Approved?
Several products fall under the regulatory purview of the U.S. Food and Drug Administration (FDA) and must undergo approval or clearance processes to ensure their safety, efficacy, and compliance with established standards. Some of the key products that generally require FDA approval or clearance include human and animal pharmaceuticals, medical devices, vaccines, biologics, foods and food additives, dietary supplements, and tobacco products.
According to Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a medical device is:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- (A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).
When a medical device receives FDA approval, it is known as a “legally marketed predicate device.” These devices have three main classes, which are Class I medical devices, Class II medical devices, and Class III medical devices. We outline the differences in each below.
- Class I Devices: These are low-risk medical devices. Examples include bandages, non-electric wheelchairs, and certain handheld surgical tools.
- Class II Devices: These are moderate-risk medical devices. Examples include CT scanners and pumps for intravenous administration of medication.
- Class III Devices: These are high-risk medical devices. They are usually very important for a person’s health or for sustaining life. One common example would be a pacemaker.
Notably, the FDA is not responsible for handling human organ transplants. This responsibility falls to the Health Resources Services Administration.
The FDA rigorously evaluates pharmaceuticals, including prescription and over-the-counter medications, through comprehensive preclinical and clinical trials. This meticulous review process examines the drug’s safety profile, efficacy in treating the intended condition, and its manufacturing quality before granting approval for market distribution.
Importantly, the FDA does not approve compounded drugs. Drug compounding is the process of mixing, changing, or combining ingredients to produce a new medicine that targets one patient’s individual needs. Generally, the process involves combining two or more drugs.
Food and Food Additives
Certain domestic or foreign food additives and colorings must undergo FDA scrutiny before being utilized in food products. Examples include texturizers and preservatives, as well as additives in the food’s packaging. The FDA assesses these substances for safety and establishes permissible levels for their inclusion. Additionally, the agency monitors food labeling to ensure accurate information is provided to consumers, contributing to informed choices and safety.
Medical foods, on the other hand, do not require FDA approval. These foods are basically created and formulated to be administered to patients under the supervision of a doctor for the dietary management of a condition or disease. The FDA does not approve medical foods, as they are not drugs and are therefore not subject to the same regulations that apply to drugs.
Technically, cosmetics as a whole do not require premarket approval from the FDA. However, color additives that are used in many cosmetic products do require premarket FDA approval. The FDA can also enforce actions against any products on the market that do not comply with the law. They can also initiate actions against individuals or companies that violate the law.
In short, cosmetics are not required to receive FDA approval. Instead, you may see an “FDA listed” or “FDA registered” label on these products. However, color additives must be approved. Unless a manufacturer uses ingredients that are prohibited or restricted by current regulations, they may use any ingredients that meet the following criteria.
- Product is properly labeled
- Ingredients and finished cosmetic products are safe when used as labeled
- Using an ingredient does not cause adulteration or misbranding of the cosmetic under current laws and regulations
Does FDA Approval Mean Anything?
Yes. The Food and Drug Administration regulates a wide variety of products that we see here in the United States. These products include prescription drugs, over-the-counter drugs, biologics, dietary supplements, medical devices, surgical implants, food additives, cosmetics, tobacco products, and infant formula.
Generally, we believe that anything with an “FDA-approved” certificate received rigorous testing. However, this is not always the case. The technical meaning behind FDA approval is that the product in question has benefits that outweigh the risks. Therefore, if a product has 51% beneficial qualities and 49% potentially harmful qualities, it could still receive FDA approval.
Essentially, the FDA approval process is flawed, and until there’s a push to revamp how the Food and Drug Administration selects the products that make their way to market, we will continue to have unsafe food, drugs, and medical devices, especially drugs.
What Does FDA Approval Mean?
Let’s be clear: the labeling system is not yet perfect. Oftentimes, companies that initially gain FDA approval end up recalling their product due to a safety hazard or product defect. In many cases, these hazards or defects result in many consumers sustaining injuries. Then, the victims of these unsafe products will pursue class-action lawsuits.
This happens because “FDA-approved” does not always equal “safe.”
In fact, many people over the years have suffered permanent bodily harm or even death after using an FDA-approved product. Notably, the FDA itself does not develop the products that it evaluates.
What Is the FDA Approval Process?
The FDA approval process is a comprehensive and systematic procedure that evaluates the safety, efficacy, and quality of various products before they can be introduced into the market. While the specific process may vary slightly depending on the type of product being reviewed, the general framework for FDA approval typically involves several key steps. These steps may include:
- Preclinical testing
- Pre-clinical trial applications
- Clinical trials
- Post-clinical trial applications
- FDA review
- Advisory Committee review (optional depending on the case)
- FDA decision
- Post-market monitoring
Importantly, the FDA assesses whether the benefits outweigh the risks for a particular product. This is especially true when it comes to drugs and medical devices. For example, consider a new drug that is intended to treat osteoarthritis. If the drug only provides mild relief to patients while causing a whole host of negative side effects, the FDA is unlikely to approve this drug.
FDA Approval Process for Testing
Additionally, it does not even conduct its own testing. Rather, the FDA reviews independent clinical testing in order to determine the safety of products.
This leaves the door open for companies to engage in less-than-honest or ideal practices, to say the least. Since huge conglomerates, such as pharmaceutical companies, can pay to have their products reviewed at any third party testing facility that they please. Testing facilities that these companies hire obviously have an incentive for the product to hit the market.
In layman’s terms: the FDA approval process for testing comes with an abundance of bias towards products that may or may not be safe.
What Is the Difference Between FDA Cleared and FDA Approval?
As we stated above, “FDA approved” just means that the benefits of a product’s intended use outweigh its known risks. In order to achieve this status, manufacturers must submit a premarket approval (PMA) application, as well as the results of clinical testing to the FDA. FDA clearance, however, is a little different.
Class II and Class I medical devices usually receive clearance. FDA clearance means that the manufacturer of the product demonstrated that the product is “substantially equivalent to another (similar) legally marketed device” that already obtained FDA clearance or approval. Before the clearance process begins, the manufacturer must submit a “premarket notification submission”, or 510(k) to the FDA. Products that receive either approval or clearance from the FDA may be marketed or sold in the United States.
FDA Authorization vs. Approval
Although many people use FDA “approval” and “authorization” interchangeably, they do have notable differences. The FDA can issue an Emergency Use Authorization (EUA) during public health emergencies, such as pandemics, to facilitate the availability and use of medical products that may not have undergone the typical approval process. This was the case for the Pfizer and BioNTech vaccines developed during the COVID-19 pandemic.
Full FDA approval, however, is the standard regulatory pathway for products to gain clearance for marketing and distribution in the U.S. market. It has a much more involved process that takes a much longer time to complete. However, FDA approved products have generally been heavily tested and scrutinized before they receive that label.
If a Medication Doesn’t Have FDA Approval, Is It Safe?
As we demonstrated before, even those products that have the FDA seal of approval are not always safe. Therefore, products that do not have FDA approval are not always unsafe. FDA approval applies to products for their intended use. This means that, if the manufacturer intended for the product to be used for a specific purpose or a specific age group, the FDA approves its use for those purposes.
Doctors, however, can usually decide whether or not certain medications are appropriate for “off-label” use. This just means that the use for which the doctor prescribed the medication is not on the product’s label. It is a fairly common practice, and the FDA generally does not waste time or money approving one product for multiple uses. Further research generally guides a doctor’s decision to recommend a medicine for off-label use.
However, if a product does not have FDA approval or clearance at all, we simply do not know enough about it. Using drugs that have not gained the FDA seal of approval at all has the potential to be very dangerous, as we do not know who can safely use those products. Products such as vitamins or supplements, however, do not require approval. This is because they are not actually “drugs.” Before deciding to use any product for health or wellness reasons, we recommend speaking with your trusted general practitioner.
Should Drug Manufacturers Be Strictly Liable for All of Their Medicines?
There are actually several different ways in which we can hold drug manufacturers accountable for defective drug injuries. Below, we outline the most common ways in which we at Reich & Binstock tackle this issue:
Product liability laws in Texas involve strict liability. Basically, this means that manufacturers of any product, including drug companies, could be held liable for injuries caused by their product. This strict liability applies even if the manufacturer did not know about the defect. However, almost all drugs carry some sort of risk. Generally, a drug’s risk of dangerous side effects must be higher than its potential benefits to be considered defective.
Manufacturers of drugs also have a certain duty of care to produce safe products. If the manufacturer employed careless testing or production, they are liable for negligence. To prove negligence, the injured person and their legal team must show that the company knew or should have known about the potential danger.
Failure to Warn
Lastly, drug manufacturers have a duty to warn consumers about a product’s potential dangers. If they fail to provide proper warnings, their company is liable for injuries.
Did You Suffer Injuries from an FDA Approved Drug or Medical Device?
If you or a loved one suffered injuries or illness from a drug or medical device with the FDA seal of approval, contact Reich & Binstock for qualified representation. Experienced defective product attorneys provide the best chance of receiving the compensation you deserve for your injuries. We’ll stand up to medical device and drug manufacturers on your behalf, and fight for your rights. Don’t let medical device and drug companies walk all over you in an attempt to save their profits.
Contact Reich & Binstock today for an attorney who will work hard to get your life back on track. Call our Houston office at 713-622-7271, or visit our website.