The crisis, tied to contaminated steroid injections produced by the New England Compounding Center (NECC), a Massachusetts compounding pharmacy, has resulted in a flurry of investigations, hearings and accusations against the questionable practices of the company responsible. But the real solution, a growing consensus seems to agree, might be to take the issue out of state hands and into federal ones.
As Reuters noted in their analysis of the issue, the state regulatory system is a patchwork of inconsistent statutes and federal oversight is virtually non-existent. Compounding pharmacies (which mix ingredients to create a unique dosage for individual patients, as opposed to mass-produced medications) are supposed to fill only special orders from physicians. That means no bulk and non-specific orders -- yet it appears that NECC delivered them extensively.
“There is a hole in which these companies operate,” Linda Bentley, an attorney who specializes in drug regulations, told The Tennessean. “It is a clear formula for disaster, and now we have one.”
For those who haven't been following the coverage, here's a quick breakdown of the situation.
So, what went wrong?
Starting in May, NECC distributed to doctors and clinics across the country at least 14,000 contaminated steroid injections used to treat back pain causing an outbreak of fungal meningitis, the inflammation of the membranes surrounding the brain and spinal cord. It is the noncontagious form of meningitis.The disease is slow to show itself, and confirmed cases began to appear at the end of September. NECC stopped distributing the drugs on Sept. 26 and voluntarily shut down its operations.
According to the latest figures from the Centers for Disease Control and Prevention (CDC), 205 people have been infected in 14 states. So far, 15 have died.
How do state regulations factor in?
Unlike other pharmecutical companies, compounding pharmicies are not subject to oversight by the Federal Drug Administration (FDA). Instead, states are responsible for licensing them, but state laws are not homogenous and some appear to leave loopholes for companies to exploit.
Compoundng pharmacies are intended to only meet specific requests from health-care providers for specific cases. However, it appears that NECC was delivering bulk orders, and that is likely, at least in part, because of inconsistent state regulations. For example, in Idaho, retail pharmacies are allowed to distribute minimal quantities of a drug, without a prescription, in case of a short-term shortage. NECC appeared to take advantage of that loophole, as one clinic received a shipment of 40 injections without a specific prescription.
Regardless, NECC seemed to be operating outside the law. Reuters confirmed one case in which the company sent the drugs to a Mississippi customer without a prescription. Ohio officials are investigating whether the company did the same there, as more than 400 patients received the injection since May -- and authorities suspect at least some were delivered as part of a bulk order.
But, while the company clearly bears responsibility for its own actions, the lack of enforcement by state authorities appeared to allow NECC to operate unhindered until the meningitis outbreak. According to The Guardian, an industry oversight group has filed a report charging Massachusetts regulators with failing to properly monitor the company's operations.
"It's abysmal that the local authorities are calling for greater oversight," said Eric Kastango, a member of the group. "If someone just enforced Massachusetts law, these cases could have been avoided. They failed in their responsibility for enforcing what they already had."
What are states doing about it?
The CDC has partnered with the FDA and state and local health departments to undertake a national investigation, and many states have initiatied their own inquiries. The general question is whether NECC operated as a bulk distributor and manufacturer -- the two specific functions that state laws were supposed to prevent.
Massachusetts and Michigan have already accused the company of violating state laws. Other state investigations, including those in Ohio and Tennessee, could conclude the same. Legal action, which could be severe given the extent and toll of the outbreak, is likely a formality at this point.
Congress could move to put compounding pharmacies under the FDA's supervision. William Schaffner, chairman of preventive medicine at Vanderbilt University Medical Center, advocated for such action in an interview with CBS News.
"They are not regulated the way the major pharmaceutical companies are," he said. "They seem to have fallen into a regulatory gap. That's something that really needs to be addressed by the Congress."
In the meantime, states might seek to fill their own holes. California lawmakers are already considering tightening their regulations for compounding pharmacies, even though no cases have been reported there. According to The Tennessean, Tennessee Gov. Bill Haslem has said he will coordinate with the state health department to evaluate the state's laws once the current crisis has subsided. An Idaho official told Reuters that the state could reassess the loophole that allowed the infected injections to be sold wholesale in the state.
But the real push -- even from state officials -- seems to be for Congressional action. Clearly, authorities seem to agree, a state-by-state approach hasn't worked.
"We urge Congress to act quickly to address the need for new laws on the federal level to fill in the regulatory gaps," the Massachusetts Board of Pharmacy said in a statement, "so that there is clear authority over regulating these practices."
The map below, courtesy of the CDC, shows the extent of the meningitis outbreak linked to NECC's contaminated steroids.
