An outbreak of meningitis that has killed 8 and sickened nearly 100 is tied to a steroid manufactured by a company that some suggest operates more like a drug manufacturer than a compounding pharmacy. It also has focused attention on the fact that compounders don't have to meet the same strict FDA regulations that pharmaceutical plants do, even though they may be creating drugs and selling them all over the country.
Authorities said New England Compounding Center, of Framingham, MA, made the steroid believed to have been contaminated with fungus, according to the FDA. New England Compounding sold 17,676 vials to pain clinics in 23 states before the problem was uncovered, The New York Times reports. The FDA has suggested doctors refrain from using any of the company's products they have.
"The Food and Drug Administration has more regulatory authority over a drug factory in China than a compounding pharmacy in Massachusetts," Kevin Outterson, associate professor of law at Boston University told The New York Times, but said it is not the agency's fault. The FDA did develop guidelines for compounders but litigation settled by the Supreme Court in 2002 threw them out. As a result, compounders are overseen by state health authorities. In this case, the FDA and the Centers for Disease Control and Prevention were brought in by several state health agencies to help get to the bottom of the problem.
This is not the first time the FDA has had issues with New England Compounding. It sent the company a warning letter in 2006 after state regulators called the FDA in over an antiseptic cream the company was making and after it received a complaint that the company was inappropriately repackaging the cancer drug Avastin.
Compounding has traditionally been seen as a service that could provide local doctors specially created drugs for patients with special needs. But New England Compounding may have operated more like any drugmaker, selling significant amounts of its products throughout the U.S., The New York Times story says. The company earned $2.2 million last year, small by most drugmaker terms, but enough to send sales representatives to a clinic that expressed interest in its services.
New England Compounding is not the only compounder to be tied to a nationwide recall this year. Franck's Pharmacy of Tampa, FL, in late May recalled all of the products it had made in the previous 6 months after some of its products were tied to serious eye infections in some patients that received them. Last month, the FDA sent a warning letter to InfuPharma of Hollywood, FL, noting filth at its business and saying it was violating FDA regulations by repackaging Roche's ($RHHBY) Avastin.