A drug recall can be a disastrous event for a pharmaceutical company. The average drug recall can cost a pharmaceutical company more than $100 million due to FDA penalties, lost inventory, operational changes, and other costs. It can also hurt a company's public presence. It could be a very scary situation to find out that you are taking a drug that has been recalled. In many cases, individuals who have a drug that is recalled will most likely avoid that drug and the pharmaceutical company that produces it in the future. A recall can have far-reaching consequences that extend past the initial financial loss.
There are a number of reasons why a drug may be recalled. It could be due to an unforeseen health hazard that is only seen when it's in widespread public use. Clinical trials and testing may have missed something that presents itself when a larger population uses the drug. There could also be some contamination in the manufacturing process that exposes the drug to a foreign substance. It doesn't have to be harmful to be recalled. Finally, the FDA could do an inspection and determine that the manufacturing facility isn't up to code or there isn't an effective quality manufacturing system (QMS) in place to ensure quality and prevent adverse events.
Still one of the most common reasons why a drug company might face a recall is due to mislabeling. In most cases, it could be innocuous, but anything that can affects how much a patient knows about dosage or drug interaction can be serious in the wrong situation. The FDA and other regulatory bodies have very strict rules when it comes to drug labeling. In the United States, the Drug Labeling Initiative started in 1992 with the final stage of a final rule implementation completed in 2013.
Labeling must include a variety of information so healthcare professionals and patients have a full understanding of the drug, its contents, dosage, side effects, warnings, interactions, specified populations, overdose procedures, and other pertinent information. While these new drug labeling rules only apply to drugs approved after 2006, most pharmaceutical companies are following these guidelines for transparency.
Pharmaceutical companies that wish to comply must implement a quality management system to mitigate the changes of a recall due to mislabeling or some other adverse effect. They must also have a system in place when issuing drugs to foreign countries. This could include hiring professional pharmaceutical translation services to ensure the guidelines of the FDA and the regulatory organization of the target country are being followed.
A recall can greatly impact a company's bottom line and can affect the general population as a while, so pharmaceutical companies must do everything possible to ensure the safety and quality of their drug. Labeling drug correctly is one pertinent step in that process.
There are a number of reasons why a drug may be recalled. It could be due to an unforeseen health hazard that is only seen when it's in widespread public use. Clinical trials and testing may have missed something that presents itself when a larger population uses the drug. There could also be some contamination in the manufacturing process that exposes the drug to a foreign substance. It doesn't have to be harmful to be recalled. Finally, the FDA could do an inspection and determine that the manufacturing facility isn't up to code or there isn't an effective quality manufacturing system (QMS) in place to ensure quality and prevent adverse events.
Still one of the most common reasons why a drug company might face a recall is due to mislabeling. In most cases, it could be innocuous, but anything that can affects how much a patient knows about dosage or drug interaction can be serious in the wrong situation. The FDA and other regulatory bodies have very strict rules when it comes to drug labeling. In the United States, the Drug Labeling Initiative started in 1992 with the final stage of a final rule implementation completed in 2013.
Labeling must include a variety of information so healthcare professionals and patients have a full understanding of the drug, its contents, dosage, side effects, warnings, interactions, specified populations, overdose procedures, and other pertinent information. While these new drug labeling rules only apply to drugs approved after 2006, most pharmaceutical companies are following these guidelines for transparency.
Pharmaceutical companies that wish to comply must implement a quality management system to mitigate the changes of a recall due to mislabeling or some other adverse effect. They must also have a system in place when issuing drugs to foreign countries. This could include hiring professional pharmaceutical translation services to ensure the guidelines of the FDA and the regulatory organization of the target country are being followed.
A recall can greatly impact a company's bottom line and can affect the general population as a while, so pharmaceutical companies must do everything possible to ensure the safety and quality of their drug. Labeling drug correctly is one pertinent step in that process.