Saturday, June 10, 2006
AP (Yahoo) has a story about the poorly unregulated market in cadaveric tissue that will curdle your blood. I am stunned that the FDA has done as poor a job of oversight as it has:
The federal agency responsible for tissue safety, the, is well aware of the problems. Yet, many experts believe the rules the FDA enacted last year as a long-promised overhaul fall short of providing the level of oversight needed.
Each year, another germ is found to spread through tissue. Each year, the FDA inspects a smaller percentage of tissue businesses. Each year, another germ is found to spread through tissue. Each year, the FDA inspects a smaller percentage of tissue businesses.
When it does inspect, public health isn't always protected. In 2003, an FDA inspector saw that Biomedical Tissue Services — the now-notorious New Jersey company — wasn't documenting what it did with tissue unsuitable for transplant. The FDA let the matter drop after the company sent a letter saying it had fixed the problem. For two more years, thousands of people received tissue.
"I'm not surprised that a BTS (incident) occurred. And there will be others," said Areta Kupchyk, a former FDA lawyer who drafted rules that ultimately were adopted in watered-down form. "We continue to be at risk."
In a related AP story, you can read more about the potholes that plague this industry. [tm]