Does FDA Approval of a Prescription Pharmaceutical Mean it is a Safe Drug?

Ever wonder if there is anything to all these mass tort lawsuits? Many people believe that if a drug has received FDA approval, then it must have undergone rigorous research and passed extensive testing so that the government feels comfortable certifying its safety to the American people. Surely, they have done all they can to rule out the major potential harmful side effects before they allow the drug to be mass-marketed with their seal of approval on it, right? Wrong.

What Does FDA Approval of a Prescription Drug Mean?

product recallFDA approval of a new prescription drug means that the manufacturer has provided evidence to the FDA that the benefits of the drug outweigh the risks for most patients for a specific use. In the process, the FDA can require additional evidence to be provided, require additional testing and studies, and even go and inspect the manufacturing facilities. However, the FDA does not have to conduct any tests of its own in order to approve a drug.

What Does the FDA Do When a Safety Risk Emerges Post Approval?

There are a number of tools at the FDA’s disposal to inform and/or protect consumers when the widespread use of a drug shows evidence of a previously-unknown harmful side effect.  These range from issuing advisories to medical professionals and users up to issuing a Class 1 recall—the most serious level of recall.

How Common Are New Safety Risks Discovered in Newly Approved Drugs?

32% of the 222 new drugs approved by the FDA between 2001 and 2010 were followed by a recall, warning, and/or safety alert after it hit the market.  This research was published in the Journal of the American Medical Association.

The reality is, new medications undergo a limited amount of testing using a group of people that may be as few as a few hundred or as many as a few thousand. Unforeseen effects on certain people may not be discovered in these studies simply due to the underrepresentation of affected people in the study.  Additionally, once the drug is mass-produced and sold, the study group now becomes much larger so that harder-to-spot trends may emerge.

What Do the Three Classes of Recalls Mean?

A Class 1 recall indicates that the product is likely to cause serious or life-threatening injury even when used as intended. This is the most serious class of recall.

A Class 2 recall indicated that the medication either has a low risk of serious harm or may only cause temporary issues.

A Class 3 recall indicates that the medication is not likely to cause harm but that there is still some minor defect or issue that needs to be addressed.

Should I Report Side Effects from a Drug That Are Not on the Warning Label?

Yes.  New problems need to be evaluated and addressed since not all are likely to be found before approval.

Where do I Report Issues with a Pharmaceutical?

The FDA has a MedWatch Safety Information and Adverse Event Reporting Program set up specifically to receive and collect this information for reevaluation of a drug’s approval. You can reach them by calling 800-332-1088 or visiting the FDA’s website.

Why Would a Drug Company Not Do Extensive Pre-Approval Testing?

The short answer is corporate greed. The research and development phase of a new pharmaceutical can cost billions of dollars. The longer it goes on, the more pressure management is under to get the product to market. Those big CEO salaries do not get approved by the board without results. This greed is the same reason you see companies getting hit with billions in civil and criminal fines over misbranding and unapproved promotion of drugs and such.

Fast Track Approvals – Avoiding the Delay to Get to Market

In a perfect world, you would think there would be a completely independent review from the FDA free of any appearance of impropriety. However, since 1992, the manufacturers have actually funded the FDA’s approval department.  This was the result of an agreement allowing limitations on the time allowed for approval decisions of medicines in exchange for funding. See FDA Increasingly Approves Drugs Without Conclusive Proof They Work.  About 75% of the funding is from pharmaceutical companies—which leads some to question their allegiance.

What is a Mass Tort Claim?

A mass tort claim is a case against the manufacturer of a product that was distributed widely and turned out to have some sort of defect such that makes the drug potentially harmful. These can come about due to a number of reasons such as an impurity getting introduced into the drug accidentally in the manufacturing process or a previously undisclosed side effect. They may affect certain batches or the entire product line. Most commonly, we see these cases where studies suggested that there were side effects but the drug manufacturer continued to sell the product without looking into those studies and/or doing further research.  When the manufacturer becomes aware of a problem, they have a duty to warn the public and/or remedy it. The Tylenol and acetaminophen lawsuits are one of the latest examples of this type of mass tort allegation. The question in these cases is often when should they have been on alert that they needed to look into it?

Do Mass Tort Cases Result in Drug Recalls?

Sometimes mass tort claims may spur a review leading to a recall, but often they do not. Instead, many corporations simply create a new warning label to warn consumers about the drug’s unintended side effects that are later discovered. Under product liability law, a manufacturer can get away with selling a product that he knows has dangerous side effects so long as they make a clear warning. The consumer is entitled to know all known risks. Once the risk has been advised to the consumer, the risk transfers from the product makers and sellers to the consumer.  Likewise, the FDA will weigh the risks and benefits in a sort of balancing act. If the FDA decides that the benefits of the drug to most outweigh the risks to some, they may still approve it. Now, do you see why some people question allowing big pharma to fund any part of the FDA?

What is a Black Box Warning Label?

A black box warning label is the highest degree of warning that the FDA can require just short of a recall. That label is required to be specific and conspicuous to warn of the dangerous risks of using the drug and the language of it must be approved by the FDA. The Beovu litigation is an example of a situation where the FDA came in and required a black box label.  Other times of less serious warnings include instructions pamphlets and advisories.


Just because the FDA approves a drug for sale to the public in the United States does not mean that the drug is truly safe. It would be wise to do your own research regarding exactly what type of study and research was done to obtain FDA approval before you take a new-to-market drug.




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