We recently posted an article about how the recent meningitis outbreak could have been prevented if the FDA had the proper authority to regulate the drug compounding industry. According to a recent NY Times Article, drug compounding companies have been able to avoid tighter regulation thanks to their powerful friends in Congress.
Larry D. Sasich, a research pharmacist who has written about compounders’ safety record, tells the NY Times that “a lot of the blame for the meningitis situation lies at Congress’s door…”
Compounding companies have earned support from politicians by marketing its products as reasonably priced and community-based in comparison to big corporate drug manufacturers. Efforts for more regulation over compounding pharmaceuticals have met resistance from politicians with compounding companies in their district.
Currently, compounding companies are regulated by state boards instead of at the federal level and by the FDA. Although both state boards and the FDA have been criticized for the meningitis outbreak, experts lay the blame, at least some of it, on Congress for failing to clearly define the FDA’s authority to regulate the industry.
According to the NY Times, the meningitis outbreak fits into an unfortunate pattern involving Congress and compounding companies since the 90’s. A series of deaths or illnesses gains is publicized throughout the media and sparks public outrage. Expert witnesses then spread caution Congress over the dangers of the unregulated industry. This is met by proposals to fix the system, but in the end, nothing happens.
After contaminated medicine caused a death and five illnesses in 2002, one pharmacist testified before the Senate, warning of the extreme risk unregulated compounding companies cause the public. Unfortunately, this testimony did not bring about change to the system.
Congressional hearings occurred on Wednesday and Thursday on the deadly meningitis outbreak. Are the casualties from this outbreak large enough to move Congress to bring more regulation to the industry? Or will it cause more talk but no action, like in 2003?
And remember this the next time powerful interests want to limit the rights of consumers and patients to recover full and fair damages. Insurance company driven “tort reform” effectively shields companies engaging in this type of behavior – they simply won’t be accountable for the harm they cause.