The U.S. Food and Drug Administration (FDA) is responsible for policing all prescription and over the counter medications and medical devices. The agency ensures devices and drugs comply with mandated safety standards and ensures manufacturers abide by advertising rules. Unfortunately, the FDA sent far fewer advertising letters out this past year.
News and Updates
There is a fine balance between providing lifesaving medicine to the public and protecting the public from potentially harmful medicine. This is the line the U.S. Food and Drug Administration (FDA) must walk as it regulates drugs and medical devices. However the agency is making tremendous strides in patient safety by allowing more drug inspections in manufacturing facilities overseas.
As patients, we expect the prescriptions our doctors give us to be safe to take. However, a recent study found this might not be the case. Researchers determined one out of every three medications poses additional safety risks after approval from the U.S. Food and Drug Administration (FDA).
The Senate’s Committee on Health, Education, Labor, and Pensions is currently reviewing a new Bill that would open up eligibility for FDA priority review for all medical devices. The Advancing Breakthrough Devices for Patients Act is trying to make quality medical devices more readily accessible for doctors and patients, but opponents of the Bill worry that it will increase the likelihood of defective medical devices hitting the market and harming patients.
The Food and Drug Administration (FDA) has a detailed process for approving medications and medical devices. Sometimes the process is sped up for medications or cures that are the first of their kind or substantially better than currently available medications. Neither all medications nor all medical devices go through the same expedited approval process.