Fifteen people have died and several hundred have been infected in an outbreak of meningitis contracted from contaminated spinal steroid injections. The numbers are growing and so is awareness of the growth of a little known corner of the pharmaceutical industry, called compounding pharmacies, which is responsible for the tragedy. “We’re nowhere near the end of this problem,” Dr. William Schaffner, an infectious diseases expert at the Vanderbilt University Medical Center in Nashville, told CBS This Morning.
The compounding pharmacies originally were supposed to provide customized medication for individual patients but have morphed into bulk manufacturers outside of FDA’s regulatory reach.
At the heart of the tragedy is the compounders’ successful track record blocking FDA authority that could have averted the disaster. Their efforts are a textbook model of industry opposition to new rules that could save lives. Their arguments are the same that the Chamber of Commerce and industry are using today to block clean air,