Ignoring the obvious

Published: Saturday, October 13, 2012 at 10:21 p.m.
Last Modified: Saturday, October 13, 2012 at 10:21 p.m.

You have to love Congress.

As the death toll from a national meningitis outbreak climbs, members of the House and Senate have started pounding their fists on their desks demanding to know how this could happen and why the Massachusetts Board of Pharmacy didn't deal more decisively with the compounding lab that created the bad pain medication believed to be responsible for the deaths.

The irony is, this is the same group of lawmakers who have ignored the Food and Drug Administration's repeated warnings about the growing danger of compounding labs.

The FDA has testified before Congress, written reports to Congress, done everything it can to sound the alarm.

The agency's concern was that, unlike big pharmaceutical companies that must meet exacting federal tolerances for the drugs they dispense and the manner by which they create them, small compounding labs are barely regulated at all.

The reason is that, until the last 40 years or so, most medications purchased by consumers were mixed in the back of neighborhood pharmacies, and there was little need for the federal government to regulate every local pharmacist who was dispensing a few doses at a time.

So Congress left the little pharmacists alone and rightly concentrated its efforts on Big Pharma, which produces the vast majority of the nation's drug supply and has the potential to do greater harm to a larger number of people.

The rule was, compounding pharmacists could produce medications for people as long as the patient had a doctor's prescription.

But in the last 20 years, some clever pharmacists realized there is a lucrative niche between the little neighborhood pharmacy and the multibillion-dollar pharmaceutical companies like Pfizer, GlaxoSmithKline and Merck.

These pharmacists saw a need for a lot of medications that the major pharmaceutical companies quit producing or weren't producing in sufficient supply because they weren't profitable. So they created compounding labs and began producing larger and larger quantities of these drugs, largely without the stringent oversight of the FDA.

Today, these compounding labs look like pharmaceutical manufacturers and act like pharmaceutical manufacturers but continue to insist that they are little ol' neighborhood pharmacists filling prescriptions for patients and doctors — except now it's hundreds or thousands of prescriptions at a time, instead of a few here and there.

The danger, of course, is that if a neighborhood pharmacist makes an error in a prescription for a single patient, he injures or kills one person. But if a compounding lab makes a mistake, it can injure or kill dozens, or hundreds or thousands.

This is why compounding labs need to be treated like the pharmaceutical manufacturers they are and put under FDA oversight.

Seems clear, right? It is ... to everyone except Congress.

The FDA has tried everything. It has badgered Congress and been met with a collective yawn. It has sued mistake-prone compounding labs and lost because, as the judges correctly point out, the agency doesn't have the regulatory authority to close or sanction compounders.

So while Congress fiddles, Rome burns.

In recent years, we've had three national scandals involving compounding labs, two emanating from Ocala and, amazingly, all three intersecting with our community.

In 2009, Franck's Compounding Lab mixed a bad vitamin supplement for two dozen expensive polo horses, and the horses died. Then last year, tainted ophthalmic solutions prepared at Franck's injured more than three dozen patients in several states.

And now the meningitis debacle. As of Friday, 184 people in 12 states had fallen ill — and two people have died in Marion County — after being injected with a steroid created by New England Compounding Company in Framingham, Mass. Health officials worry that the toll will continue to grow because as many as 17,000 doses of the steroid made their way to pain clinics in 23 states.

And where is Congress? It's outraged, members say. According to Reuters, the House Commerce Committee wants to know what the Massachusetts Board of Pharmacy knew about NECC and when they knew it. Not to be outdone, the Senate Health Committee wants to talk to "critical stakeholders" about the outbreak.

But as Congress looks for someone to blame for its own inaction, there remains one inescapable truth: Only Congress can fix this by updating the nation's drug laws to reflect the fact that compounders are, in 2012, behaving like drug manufacturers and should be held to the same quality control standards.


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