Jeffrey Nadrich, founding attorney and owner of the California law firm Nadrich Accident Injury Lawyers, supports heightened regulation of compounded drugs.
“Heightened regulation of compounded drugs is necessary to protect Americans from dangerous side effects,” Nadrich said.
The FDA has recently warned against using compounded drugs produced by a facility in California, warning the drugs may be contaminated. The facility makes compounded versions of popular GLP-1 RA drugs which are in short supply. GLP-1 RA drugs are popular medications used to treat diabetes and obesity, and include Ozempic and Wegovy.
The recent recall highlights the need for greater regulation of compounding facilities nationwide. Worldwide demand of GLP-1 RA drugs is outpacing supply and therefore consumers find themselves relying on compounding pharmacies to obtain the popular weight loss drugs like Ozempic.
This is not the first time that drug contamination has been a problem with compounded drugs. In 2012, a fungal meningitis outbreak traced to a compounding center in New England led to 798 illnesses and over 100 deaths. An investigation of the compounding center found unsanitary conditions.
While drug compounding can fulfill patients’ needs when other solutions can’t, there are drawbacks to compounding. Compounded drugs are not approved by the FDA, meaning the agency does not verify their quality, effectiveness or safety. In addition, while the FDA is authorized to inspect compounding pharmacies, the pharmacies aren’t required to undergo routine inspections by the FDA, or follow good manufacturing practice standards.
The pharmacies are also not required to register with the FDA. This leaves the FDA without a complete list of these pharmacies. As a result, the agency often only becomes aware of problems with these pharmacies and the drugs they compound after receiving adverse event reports or complaints.
“Contaminated drugs will continue to find their way to consumers if heightened regulation of compounded drugs is not enacted,” Nadrich said.
Nadrich Accident Injury Lawyers support those injured by dangerous drugs such as Ozempic and Wegovy, helping them recover financial compensation for medical bills, lost wages, pain, suffering and more. The firm has resources available on their website for those injured by dangerous drugs, and has 17 offices in California.
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