How Does the FDA Fit into the Process of Drug Recalls?
Before a new drug is released on the market, the drug manufacturer is charged with performing extensive tests and trials to ensure the drug is safe and effective for its intended use. Because all drugs have potential side effects, the drug manufacturers are also required to report any potential side effects or risks they discovered while testing the drug.
Results of Trials and Tests Reviewed by FDA’s CDER
Companies send the results of their tests to the FDA’s Center for Drug Evaluation and Research (CDER) to be evaluated. The CDER provides information to doctors and patients for the safe use of the drug based on the test results and other information gathered. The CDER also reviews the company’s proposed labeling for the drug. The center does not test the drugs that are submitted for review, but it will conduct limited research for safety, drug quality, and effectiveness standards.
To obtain FDA approval, the CDER must conclude its review of the research and information provided by the drug manufacturer. The CDER must find that the drug provides benefits that outweigh the potential and known risks for the intended consumers. The FDA then:
- Analyzes the target condition and any available treatments;
- Assesses the risks and benefits of the drug from the clinical data; and,
- Develops any strategies needed for managing risks.
The above process is only one way a drug can get onto the market through the FDA. The FDA also has accelerated approval, fast track, breakthrough therapy, and priority review processes.
What Happens When a Dangerous Drug is on the Market?
Sometimes, a drug will make it to market with FDA approval without any issues. However, when there is widespread use of the new drug, previously unknown side effects and other problems can arise. When this occurs, the company may issue a voluntary recall. Recalling a product is the most effective way to remove a potentially dangerous product from the market and protect the public.
What Is the FDA’s Role in The Drug Recall?
The FDA’s key role in a drug recall is to oversee a company’s recall strategy and assess whether the strategy is adequate. In most cases, a company issues a voluntary recall, although some recalls are made after the FDA raises a concern. In rare cases, the FDA will request a recall.
The FDA is notified of a problem with a drug in one of several ways. The drug manufacturer may discover the problem and notify the FDA or the Centers for Disease Control (CDC) may notify the FDA. The FDA may receive reports from various reporting systems of health problems associated with the drug. In some cases, the FDA will identify a problem during an inspection of a manufacturing facility.
In some extreme cases, the FDA may hold a press conference or release the information to the public in another way so that the information is spread quickly to as many people as possible. This tactic is usually reserved for a drug that is a serious hazard that was distributed widely to many consumers.
A Weekly FDA Recall Report
In most cases, the FDA includes all recalls in its weekly Enforcement Report. The report lists all recalls, by classification, with information about the action being taken to recall the product. You can also check the Recalls, Market Withdrawals, & Safety Alerts page on the FDA website for additional information about drug recalls and safety alerts. On both pages, you can sign up to receive notices and other information about recalled drugs. For patients who may be concerned if they will be prescribed a drug on this list, they can check the list or sign up for notices.
The FDA continues to evaluate the effectiveness of the recall to ensure everything is being done to retrieve the dangerous drugs. When the recall is complete, the FDA monitors the destruction of the bad drugs and investigates why the product was defective.
Classification of Recalls
Recalls are classified into one of three classes. The classes are based on the level of danger to the consumer or public.
- Class III Recall — Products in a Class III recall are not expected to cause any adverse health condition, but the manufacturing or labeling of the drug violates FDA laws.
- Class II Recall — A Class II recall is used for drugs that present a slim threat to patients or the public because they might cause a temporary health problem.
- Class I Recall — A Class I recall is the most serious recall. Class I recalls are reserved for defective or dangerous drugs that could cause serious health problems and death.
The above classes are used with products other than dangerous or defective drugs. In addition to human drugs, the above classes also cover other FDA-regulated products including:
- Animal drugs
- Medical devices
- Blood and blood products
- Radiation-emitting products
- Animal feed
- Transplantable human tissue
In addition, about 80 percent of the food eaten in our country is also subject to the FDA class recall.
Get Help from a Defective Drug Law Firm
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If a bad drug has injured you, we want to hear your story. Contact our office for a free consultation by calling 1-866-FOX-FIRM or 1-866-369-3476.
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