Despite New Federal Regulation, Compounding Pharmacies Continue to Cause Health Hazards
In 2012, a sudden outbreak of fungal meningitis that began in Tennessee, but quickly popped up elsewhere across the US, was traced back to the New England Compounding Center, a compounding pharmacy that created drugs in such an unsanitary environment that federal investigators reported they could see visible particles floating in the vials.
The NECC’s steroid injections were created to help treat people with severe, chronic back pain. However, because compounding pharmacies had little federal oversight until very recently, the drugs were not sterile and led to 751 cases of fungal meningitis. A total of 64 people died because of the infection.
After the outbreak was contained and the NECC shut down, President Obama signed new regulations into law so the FDA can oversee compounding pharmacies more closely, to help prevent such a tragedy again. However, compounding pharmacies continue to distribute unclean drugs. FDA crackdowns since October 2012 have drastically increased the number of drug recalls in the US.
Compounding pharmacies have complained about the stringent new regulations, which they claim will delay or prevent life-saving drugs from reaching patients. Compounding pharmacies should create drugs in very small batches, for one or a small number of specific patients, who cannot get these drugs commercially.
“We are out there doing more inspections … (and) a substantial portion of the recalls are linked to problems we discovered during those inspections,” says Ilisa Bernstein, deputy director for compliance at the FDA’s Center for Drug Evaluation and Research. Compounding pharmacies got little oversight before the meningitis outbreak, she says, but “the seriousness of the findings (in) the inspection reports we’ve issued suggests there also were many problems prior to 2012.””
“There was a very uncertain legal framework surrounding pharmaceutical compounding,” says Elizabeth Jungman, a drug safety expert at the Pew Charitable Trusts. “It made it really difficult for the FDA to exert the oversight over compounding that consumers might expect.”
“The FDA was caught by Congress and others for being asleep at the switch in the NECC tragedy. … So (the agency) said, ‘OK, we’re going to go in and inspect (compounders) as if they’re a manufacturer,’ ” says David Miller, CEO of the International Academy of Compounding Pharmacists. “It’s like going to the baseball diamond with your buddies, and the other team shows up wearing helmets, padding and carrying a football.”
Specialty Compounding in Texas recalled all of its sterile medications recently, after being cited numerous times by the FDA, and discovering that all the patients made sick by their drugs had caught Rhodococcus equi.
“None of these products should be used,” the Centers for Disease Control and Prevention said in a national health alert, warning of “bloodstream infections potentially related to the company’s calcium gluconate infusions.”
Another Texas company, NuVision Pharmacy, also recalled all of its injectable drugs after it failed a July 2014 inspection.
In September, the FDA issued a warning to doctors and consumers “due to the seriousness of this situation.”
Nashville, TN compounding pharmacy John Hollis Pharmacy was also issued 11 citations in September this year for failing sterility inspections and failing to provide the names of individual patients they provided drugs for.
The Strom Law Firm Can Help with Personal Injury Claims from Dangerous Drug Recalls
If you or a loved one have been injured, harmed, or killed by a medical product such as a drug or device, you may be entitled to file a personal injury lawsuit. Defective medical devices and dangerous drugs can hurt you to such a great extent that you are unable to work. You will face mounting medical bills as you seek treatment for another’s mistake. The attorneys at the Strom Law Firm can help get you the compensation you deserve, to get you through these tough times. We are licensed to practice across South Carolina, Georgia, and New York. To help you with your case, we offer free, confidential consultations. Do not hesitate to contact us. 803.252.4800