FDA Actions – The Life Cycle of a Bad Drug

Certain FDA actions are taken to keep the consumer safe.  The Food and Drug Administration (FDA) approves a drug for the market after it has received an initial analysis of the drug’s risks and benefits.  But, often times drug risks are not known until after the drug hits the market and it is the responsibility of the manufacturer and the FDA to warn the public when such risks are determined to outweigh the benefits.  Monitoring drug safety after the drug has been approved and is on the market is often referred to as “post-market surveillance’.

Post-market surveillance may entail required studies but is often done through an FDA computerized database called the FDA Adverse Event Reporting System (FAERS).  Clinical reviewers monitor the safety of products that are reported in FAERS.  If they find safety to be an issue during the life cycle of the drug, they will ask the FDA to take regulatory action.

FDA Actions

One very large problem in tracking adverse events and the safety profile of drugs is that reporting of adverse events to the FDA is strictly voluntary.  The FDA asks consumers, healthcare providers, family members and lawyers to voluntarily report these adverse events to MedWatch, the voluntary reporting system.  In addition, if the manufacturer of the drug receives an adverse event report, they are also required to send the report to the FDA.

Drug safety professionals estimate that only 10% of adverse events are reported to the FDA every year, grossly underestimating the number of adverse events in the drugs we take on a daily basis.  TruLaw is designed to be a safety advocate for you when we learn of adverse events that have not yet resulted in FDA actions.  Consumers must do their homework in order to make informed decisions about the drugs they take. 

TruLaw encourages all individuals to report all adverse events to the FDA through their MedWatch program. 

What Is A Black Box Warning?

A black box warning is the strongest warning that the FDA requires and signifies that medical studies indicate that the drug carries a significant risk of a serious adverse event.  The FDA requires this warning to appear on the prescription drug’s label and it is designed to call attention to serious life-threatening risks.

Drug companies do not like black box warnings – studies on prescriptions and why

Removal From The Market

If the FDA determines that needs to be removed from the market it can either recall it or ask the manufacturer of the drug to withdraw it.  Drug recalls may be done by the drug manufacturer or required by the FDA and are generally ranked based on the seriousness of the risk from Class I to Class III.  Class I recalls are situations in which there is a reasonable probability that the use of or exposure to a violative product will cause serious injury.  Class II recalls are situations that may cause temporary or reversible health consequences or serious adverse events where the probability is remote.  Class III recalls are generally done because of a mislabel and are not likely to cause adverse events.

The drug may also be removed from the market through a market withdrawal which occurs when a product has a minor violation that would not be subject to FDA legal action.  In a market withdrawal, the drug company often removes the drug just long enough to fix the problem and then brings the product back to the market.  Market withdrawals may occur as a result of tampering.