by: Jeff S. Gibson, Attorney
I’ve previously discussed the role of the U.S. Food and Drug Administration (FDA) and its oversight of medical device and pharmaceutical products. With so many stories in the news about food and drug dangers, consumers need to understand the function of the FDA and how it works to protect them.
The FDA protects consumers against harmful drugs and medical devices in two ways. First, the administration has an approval process that all manufacturers must complete before a product is approved for market. Second, the FDA monitors the safety of these drugs and medical devices through a reporting system used by healthcare professionals, product manufacturers, and consumers. If the FDA determines that a drug or device poses a safety risk, it may issue or require a manufacturer to issue communications including safety warnings, label changes and product recalls.
One of the ways in which the FDA facilitates after- market safety reporting for drugs and medical devices is through its MedWatch reporting program. MedWatch is a system for collecting information and serious problems with drugs, medical devices, and other FDA-regulated products. Consumers and health care professionals report adverse events directly to the FDA through this database. The FDA analyzes these reports for trends and takes action to ensure consumer safety.
Some examples of adverse events include hospitalization, disability or permanent damage, congenital anomaly or birth defect, required intervention to prevent permanent damage, life threatening situations, and death.
FDA Makes It Easy for Consumers
The FDA recently changed its MedWatch reporting system to make it easier for consumers to report problems. Many consumers research medical conditions and treatment options online. The FDA identified this as an opportunity to gather more information regarding drugs and medical devices by encouraging consumer feedback.
Consumers can file a MedWatch report directly with the FDA using the new form, or they can ask their health care professional to file the report with either the FDA or the manufacturer of the drug or medical device.
The MedWatch reporting system is effective and becomes more important as more consumers and health care professionals participate. In fact, the FDA recalled a particular lot of pre-filled syringes based on consumer reports to MedWatch. The agency has also taken action on other drugs after reviewing adverse reports.
Consumers can help protect themselves from dangerous drugs and medical devices by educating themselves and taking an active part in their medical care. Patients should understand the risks associated with treatment and participate in reporting adverse events to help get dangerous products off the market.
The Importance of Reporting Adverse Events to the FDA
by: Jeff S. Gibson, Attorney