Is the Food and Drug Administration doing enough to protect the public from dangerous drugs? After the deadly meningitis outbreak caused by an unsterile pharmacy facility, the answer appears to be no. The commissioner of the FDA even said that they need to improve their investigation policies and be more aggressive with compounding pharmacies in the U.S.
Safety advocates agree that the FDA has not been able to protect consumers from unsafe or defective drugs, citing the meningitis outbreak that killed more than 50 people. Reports show that the FDA received complaints over the safety and sterility of the facility, but the FDA did not shut down the facility despite having several years worth of safety incidences that could have made the company's pharmaceutical products unsafe.
The deadly outbreak led to many questions regarding compounding pharmacies. Compounding pharmacies prepare prescriptions and are usually regulated by the state health department. However, some companies actually produce so many prescriptions that they should be regulated and overseen by the FDA. However, since many of these companies do not report how much medicine they generate, it is up to the state and FDA to determine who will be regulating the company.
To make matters worse, a new report by the government shows that states often fail to oversee these pharmacies and recommended that the FDA try to improve their communication with state regulators to help keep unsafe pharmaceutical companies from distributing products.
Due to the inability of states and the FDA to regulate and investigate these pharmacies, many agencies have called for legislators to change current laws to give the FDA authority to enforce the same manufacturing standards that drug makers have to meet before their products can be distributed in the U.S.
Unfortunately, until some changes are made or communication is improved between state regulators and the FDA, consumers should be on the lookout for more potential safety issues associated with medicine made at compounding pharmacies.
Source: Bloomberg Businessweek, "FDA Can Be More Aggressive With Pharmacies, Hamburg Says," Anna Edney, April 16, 2013