As medical mysteries go, the nationwide outbreak of fungal meningitis was solved relatively quickly.
The cases were linked to a Framingham, Mass., compounding pharmacy that provided a contaminated steroid solution to dozens of health care providers around the nation, including at least two in Cumberland County.
The New England Compounding Center quickly suspended operations and issued a voluntary recall of all its products. Doctors nationwide are now treating more than 250 people who have become ill - including 13 in New Jersey, all of them in South Jersey - and warning others who received the tainted injections to be alert for symptoms, which may not develop for weeks. At least 19 people have died nationwide from the brain infection.
But one reason the medical mystery was quickly solved is because it was no surprise to the nation's disease detectives at the federal Centers for Disease Control and Prevention. According to The New York Times, five similar cases, and one death, were traced to a compounding pharmacy in South Carolina in 2002.
And such compounding pharmacies, which customize medications, have long been at the center of an intense lobbying, legislative and legal battle on the national level.
The International Academy of Compounding Pharmacists has spent more than $1 million lobbying Congress in the last decade to block more stringent regulation of compounding pharmacies. As it stands, their products are not subject to review by the Food and Drug Administration - unlike the products of drug manufacturers.
And the intense lobbying effort and several conflicting court rulings have left the FDA unsure of its authority to regulate the compounders. Pharmacies are traditionally regulated by state pharmacy boards.
Several mom-and-pop compounding pharmacies have opened in South Jersey recently. They customize medications for individual patients, at their doctors' request, providing particular ingredients, dosages and delivery methods for the individual.
This was the original model for compounding pharmacies. But larger facilities, like the New England Compounding Center, got into the business of mass-producing customized medications and shipping them across the country. As such, they have become virtually unregulated drug manufacturers.
This is an untenable situation. No doubt, this deadly outbreak of fungal meningitis will lead to new calls to regulate compounding pharmacies - and renewed lobbying efforts to block new regulations.
Congress needs to make it clear that the work of small, local compounding pharmacies - say, turning a pill into a liquid medication for a single patient - is entirely different from mass-producing customized medications that are not subject to FDA review.
The failure to draw such a distinction in regulations has proved lethal.