Oregon's Gordon Smith plays a key role in strengthening America's drug laws
The Texas company whose drugs were responsible for three deaths in Oregon and Washington does business in a regulatory no man's land.
It's time for the federal government - led by U.S. Sen. Gordon Smith of Oregon - to ensure that companies such as ApothéCure Inc. receive the scrutiny they obviously deserve.
ApothéCure, based in Dallas, Texas, is a drug compounder, which means it doesn't manufacture pharmaceuticals from scratch, but mixes them into specialized batches. The company made a deadly mistake earlier this year when it shipped to a Portland medical clinic a drug that was 10 times the strength stated on the label.
At that potency, the drug - colchicine - is fatal with just one injection. Two patients of the clinic, the now-closed Portland Center for Integrative Medicine, died after receiving injections for chronic pain. A third person is believed to have been killed by the same bad batch of drugs after a nurse at the Portland clinic shipped some of the medicine to a medical practitioner in Yakima, Wash.
Poor oversight of industry
Such tragedies aren't unheard of in the medical field, a profession where mistakes have serious consequences. But the public has a right to expect that state and federal regulators are doing all they can to protect patients from bad drugs or incompetent care.
In this case, however, health care recipients may be surprised to learn just how lax the oversight is for drug-compounding companies.
Many 'compounding pharmacies' produce large amounts of pharmaceuticals and distribute them nationally. But they are not treated as drug manufacturers, which means they operate beneath the radar of federal drug regulators. The Food and Drug Administration has jurisdiction over manufacturers, but not over compounders.
This is one issue that ought to be addressed immediately by Smith, who responded to the Northwest deaths by convening a Senate committee hearing to investigate the status of compounding pharmacies.
Such a probe - and follow-up action - is needed.
Several remedies needed
While bringing federal regulation to the compounding industry is a needed and immediate first step, other actions must be taken to rein in the problems as well.
It is clear that several regulatory loopholes must be closed and closed immediately:
* Pharmacists must be required to report immediately to the state Board of Pharmacy any adverse events involving their drugs. It's ludicrous that this isn't required already.
* Federal and state pharmaceutical regulators must clearly define the difference between a compounding pharmacy and drug manufacturer, and then make sure both are regulated.
*Selective enforcement of compounding pharmacies must end. Simply applying the rules that already exist will reduce problems with compounders.
* Provide more than a slap on the wrist for compounding pharmacies that break the rules. Currently, even a fatal mistake may result in just a small fine or warning.
* Give the FDA more resources to police manufacturers and give the state Board of Pharmacy more ability to oversee compounders.
No matter what new rules are adopted or what resources are allocated, the risk of bad medicine always will be with us. But now regulation is so slight that the public's health is endangered.
And that hazard ought to provide more than enough reason for Smith, the federal government and the state Board of Pharmacy to act immediately.