HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Saturday, June 10, 2006

The Market for Cadaveric Tissue

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

Food and Drug Administration, 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]

http://lawprofessors.typepad.com/healthlawprof_blog/2006/06/the_market_for_.html

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