Close gaps in drug regulation

2:47 AM, Nov 23, 2012

In a time of sharp resentment toward government regulation in this country, the meningitis outbreak that has hit Tennessee and other states with devastating force provides a clear example that there are cases in which strong and comprehensive oversight of industry is absolutely vital.

A report by The Tennessean published Nov. 18 detailed how Colorado state inspectors knew of problems with New England Compounding Center’s interstate business practices in 2011. While they notified the U.S. Food and Drug Administration, neither the FDA nor (until a year later) the Colorado officials spoke to the Massachusetts Board of Registration in Pharmacy, which licensed NECC and presumably would have taken action against the drug compounder quickly.

Why the lapse in what would seem to be a logical chain of communication? According to a spokeswoman for the Colorado regulatory board, “We historically have not reported actions to other state boards, because in most states the registrants are required to report the actions (themselves).”

Amazing. And yet, all too common. In America, we expect oil companies to self-report about carelessness that could lead to spills, and banks to self-report when improper lending practices have been detected.

Expect the logical extension of this brand of thinking soon: In future, armed robbers must turn themselves in to authorities, or else face a stern reprimand. Police forces could be cut by half.

So far, 13 people have died and 82 been sickened in Tennessee, and 34 dead and 490 sickened nationwide, because NECC was able to continue manufacturing and shipping contaminated drugs though individual state and federal authorities were aware of problems with the company. Those numbers are expected to grow, as health officials continue to find potentially dangerous injection-site infections.

But at least there is no onerous government regulation of the drug-compounding industry.

It is hard to imagine that anyone who works in health care ever thought self-reporting was a good idea. The decision-makers at NECC had two goals: make money, and don’t get caught. Self-reporting? That would be counterproductive.

Those who argue so loudly for across-the-board deregulation should have to sit down for a talk with someone whose husband, wife or child received a steroidal injection for back pain, only to develop deadly fungal meningitis.

Afterward, perhaps they would join this newspaper in calling for Congress to establish a national data center for information on disciplinary actions involving licensed pharmacies, with requirements that state pharmacy inspectors communicate not only with the FDA, but with pharmacy boards in states where the cited company has operations.

It is not regulators who committed these crimes of malice or negligence; it was the drug makers. But we cannot waste any more lives while we wait for them to police themselves.

Source found here