Healthcare Matters

Can you envision the supply chain? Grinding medicine into specialized doses for individual, special-needs patients; it conjures up an image of a bygone era. But it’s actually not a “thing” of the past. In fact, there is a growing need in the marketplace for “personalized medicines,” so making them is still big business. But for some strange reason it remains unregulated –and scaling what is supposed to be a per-order-based custom manufacturing process turns out to be a very dangerous enterprise. Just ask New England Compounding Center (NECC).

By now you’ve probably heard that NECC is at the center of the deadly meningitis outbreak. What exactly is the NECC guilty of? The compounding pharmacies were supposed to provide customized medication for individual patients but in their attempts to achieve scale, they have evolved into bulk manufacturers and have managed to do it outside of the FDA’s regulatory jurisdiction. At the heart of the current tragedy is NECC’s successful track record in blocking the very same FDA authority that could have averted the disaster. Their successful opposition to the very same rules proposed by the FDA that would have prevented the death of 23 (at the time of this post) will turn out to be suicide for their business and a tipping point for the industry.

Dr. Jay Wolfson, with the University of South Florida’s College of Public Health, says what many may not know about compounding pharmacies is that while they’re licensed, they are not regulated. “Just because something is out there and doing business in an area where you think there would be regulations, doesn’t mean a state or federal government has taken the time and energy and overcome the political obstacles to regulate it,” Wolfson said. “I’d think this would set up a red flag to everyone who uses formularies,” Wolfson said. “It behooves those who are in charge of the ordering, the hospitals and the clinics and the physicians to ask more aggressive questions, check on what your formulary is, who are they, are they in your state, are they licensed by your state?”

Dr. Wolfson said back in 1996, then-commissioner of the FDA David Kessler warned about this very type of thing. He told Congress the drug compounding pharmacies would create “a shadow industry” of unapproved drugs. He said that could result in major injuries or even death. In 1997, at the urging of regulators who were concerned that the compounders looked increasingly like mass-producing pharmaceutical manufacturers, Congress passed a law that gave the FDA clearer authority to treat drug compounders like drug makers. Four people died from meningitis in 2001-02 after they received contaminated back pain shots. In 2002, the compounders sued and the U.S. Supreme Court struck down the 1997 law.

In October 2003, the Senate Committee on Health, Education, Labor and Pensions held hearings in response to “a significant number of very real problems caused by compounded drugs.” Senator Christopher Bond reported that they had “received reports of nonsterile eye drops causing blindness, spinal injections contaminated with bacteria and/or fungus, resulting in hospitalization and, in some cases, death, and children poisoned as a result of pharmacy compounding errors.” Again, the industry testified — successfully — against FDA regulation.

In 2007, Senators Edward Kennedy (D, Mass.), Pat Roberts (R, Kan.), and Richard Burr (R, N.C.) proposed the Safe Compounding Drug Act to address the regulatory gaps. International Academy of Compounding Pharmacies executive David Miller, told Reuters that the federal regulations would “strangle the industry.” And the bill was killed yet again.

One might think that it’s now safe to assume that congress will take action. But given their successful track record, who knows if congressional efforts will get any traction. Hopefully, Congress will take the step they should have taken 15 years ago to close the regulatory loophole.

—Tom Finn