Generic drug safety the subject of proposed legislation
The Federal Drug Administration (FDA) monitors drug safety in an effort to keep the public safe. All citizens, including those in the St. Louis area, benefit from the regulations put in place by the FDA. One such regulation that is monitored by the FDA is the requirement of drug manufacturers to report all pharmaceutical information, including drug side effects. However, the law has a loophole for generic drugs where reporting of side effects is not required.
A New York Assemblywoman, Amy Paulin, is working to change the laws pertaining to side effect reporting for generic drugs. She has recently introduced a bill that is not in front of the Assembly Health Committee. It would require that pharmaceutical companies disclose drug safety information including drug interaction and side effects for all generic prescription drugs, just as with non-generic drugs.
Assemblywoman Paulin introduced the bill on the heels of a case involving a woman who took a generic anti-inflammatory medication to alleviate pain in her shoulder. The drug had side effects that led the woman to develop Steve Johnson syndrome, a rare skin condition that results in deterioration of the epidermis. Due to the condition, the patient suffered multiple surgeries and other medical problems.
Pharmaceutical liability is a serious matter and drug interaction can create many problems, even wrongful death. Understanding your patient rights can be an important matter. Talking to an attorney experienced in this area may be a good way to learn what you can do if you believe you have been given a defective drug or been subject to adverse side effects from a medication.
Source: Legislative Gazette, “Bill would require disclosure of generic drug side effects,” Tiffany Brooks, July 15, 2013