Pharma Regulation in The United States
Regulating pharmaceutical products is very important to ensure the health and safety of those who use them. In the United States, the Food and Drug Administration (FDA) is the federal agency which has the responsibility of regulating drugs to ensure that they are both safe and effective. The agency also has the authority to enforce pharmaceutical compliance in the US. The FDA instituted the Strategic Action Plan for Risk Communication which explains to consumers how the agency makes decisions regarding the safety and effectiveness of the products they regulate. The Center for Drug Evaluation and Research (CDER) is the organization inside the FDA that evaluates drugs to ensure their safety and effectiveness.
How does the FDA regulate drugs?
The process of regulating pharmaceutical products begins with collecting pertinent facts about the drug. A company which wants to market a new drug will have to perform extensive laboratory testing as well as animal testing to demonstrate how the drug works and if it is safe enough to move to the next step of testing it on human subjects. The company will submit an Investigational New Drug Application to the FDA before beginning testing on the human population. The company will then perform a series of clinical tests in humans while the FDA monitors. This will test the drug’s effectiveness and level of safety. All the data from the tests are sent to the FDA for them to evaluate. If the review by the CDER determines that the benefits of the drug outweigh the known risks then it can be approved to be marketed. Once the drug is on the market, the FDA will continue to monitor its performance. They will retrieve reports from consumers, pharmaceutical companies and health care practitioners. The agency also has access to numerous databases which collect various types of information pertaining to prescription drugs and their health outcomes. This data helps the FDA determine the types of side effects caused by medications. Whenever there is a health risk detected, consumers and healthcare professionals will be issued a Drug Safety Communication. At this time a statement will be added to the drug’s label to explain the new safety concern. There are times that drugs are removed from the market because it has been determined that a safety risk which outweighs the drug’s benefits exists.
Safety Data and Limitations
While a clinical trial using humans is being conducted, the FDA provides guidance to the companies. Although the data collected from human trials is carefully evaluated and analyzed by a team of experts long before the drug can be approved, it is impossible to anticipate any rare side effects or all the possible bad reactions. Even after a drug has been approved they can unexpectedly react with other drugs the patient is taking. These factors can make it very difficult to predict how humans will react to a new drug. And another fact is that the effect of the drug on a person can even change when it is taken over the course of a few years. MedWatch is a voluntary reporting system which reports adverse events and serious drug reactions each year. However, there are literally hundreds of thousands of drug reactions that fail to be reported each year. Since the healthcare system in the United States is not integrated it can be very difficult for the FDA to monitor a drug’s affect after years of consumption. However, the FDA has the Sentinel Initiative which is currently working on developing capabilities which will integrate data from various health systems so that their safety is better understood in practical uses.
Monitoring by the FDA
The FDA has the enormous responsibility of evaluating the safety of new drugs before they are ever released for human use. They have to analyze data to determine what types of safety risks a new drug might pose to the population. After a drug is released to the market and people have begun taking it, they still monitor for new information pertaining to its safety. The FDA has to visit and revisit the data about a particular drug continually throughout the lifecycle of the drug. In the end, no matter how much data are available it can often come down to a judgment call which weighs a drug’s known benefits against its known risks and even potential or unknown risks.
How does the FDA regulate drugs?
The process of regulating pharmaceutical products begins with collecting pertinent facts about the drug. A company which wants to market a new drug will have to perform extensive laboratory testing as well as animal testing to demonstrate how the drug works and if it is safe enough to move to the next step of testing it on human subjects. The company will submit an Investigational New Drug Application to the FDA before beginning testing on the human population. The company will then perform a series of clinical tests in humans while the FDA monitors. This will test the drug’s effectiveness and level of safety. All the data from the tests are sent to the FDA for them to evaluate. If the review by the CDER determines that the benefits of the drug outweigh the known risks then it can be approved to be marketed. Once the drug is on the market, the FDA will continue to monitor its performance. They will retrieve reports from consumers, pharmaceutical companies and health care practitioners. The agency also has access to numerous databases which collect various types of information pertaining to prescription drugs and their health outcomes. This data helps the FDA determine the types of side effects caused by medications. Whenever there is a health risk detected, consumers and healthcare professionals will be issued a Drug Safety Communication. At this time a statement will be added to the drug’s label to explain the new safety concern. There are times that drugs are removed from the market because it has been determined that a safety risk which outweighs the drug’s benefits exists.
Safety Data and Limitations
While a clinical trial using humans is being conducted, the FDA provides guidance to the companies. Although the data collected from human trials is carefully evaluated and analyzed by a team of experts long before the drug can be approved, it is impossible to anticipate any rare side effects or all the possible bad reactions. Even after a drug has been approved they can unexpectedly react with other drugs the patient is taking. These factors can make it very difficult to predict how humans will react to a new drug. And another fact is that the effect of the drug on a person can even change when it is taken over the course of a few years. MedWatch is a voluntary reporting system which reports adverse events and serious drug reactions each year. However, there are literally hundreds of thousands of drug reactions that fail to be reported each year. Since the healthcare system in the United States is not integrated it can be very difficult for the FDA to monitor a drug’s affect after years of consumption. However, the FDA has the Sentinel Initiative which is currently working on developing capabilities which will integrate data from various health systems so that their safety is better understood in practical uses.
Monitoring by the FDA
The FDA has the enormous responsibility of evaluating the safety of new drugs before they are ever released for human use. They have to analyze data to determine what types of safety risks a new drug might pose to the population. After a drug is released to the market and people have begun taking it, they still monitor for new information pertaining to its safety. The FDA has to visit and revisit the data about a particular drug continually throughout the lifecycle of the drug. In the end, no matter how much data are available it can often come down to a judgment call which weighs a drug’s known benefits against its known risks and even potential or unknown risks.