Compounding pharmacies were only a fairly obscure $2 billion a year niche-industry regulated by state regulatory agencies until a recent outbreak of fungal meningitis caused by tainted pain relieving injections placed the industry firmly in the national spotlight.
Last year the outbreak killed 53 people, sickened over 720, and may have exposed as many as 14,000 patients to a relatively rare form of fungal meningitis.
Many were shocked to find out that, although compounding pharmacies make customized medications for doctors and medical institutions nationwide, the U.S. Food and Drug Administration (FDA) does not regulate the industry. Rather, the pharmacies are overseen by state agencies that rarely, if ever, communicate with each other. Each state has varying sets of rules with varying degrees of expertise and oversight powers when it comes to regulating compounding pharmacies.
According to a report issued by Congressman Ed Markey (D-MA), many of these state agencies don’t even know basic information such as which pharmacies are compounding drugs or how much medication they make.
Congress is now working on legislation that would give the FDA the power to oversee compounding pharmacies, but the industry is pushing back and has already spent millions of dollars on political contributions and lobbying efforts in an effort to fight federal oversight.
A recent FDA sweep of 31 drug-compounding facilities revealed that investigators found problems severe enough in 30 of the pharmacies to serve them with inspection reports, which is the step prior to formal action. Disturbingly, at least four of the targeted companies tried to block FDA access to their facilities and records. Two had to be served warrants for inspectors to gain access.
It’s obvious that when the pharmaceutical industry puts profit before safety, Americans get sick or die. If you have been injured by a tainted medication, contact the pharmaceutical injury attorneys at Farah & Farah to review your legal options. We can be reached at (800) 533-3555 or contact us online. Your case review is free and confidential.