Thursday, October 28, 2010
Feds finally take action against small pharma company known for its repeated manufacturing problems
Pharmalot is reporting today that earlier this week, the FDA seized prescription and over-the-counter products from a little-known company in New Jersey, Tri-Med Laboratories, for repeated manufacturing deficiencies - a lack of protocols, questionable test results and non-existent cleaning methods, among other things - that caused various products to be considered adulterated. That's bad, but what makes the story worse is the fact that the FDA had known of the problems since 1997! Back in 1997, the FDA issued a warning letter to the company outlining the problems. Seven years later, the same thing happened and again in 2009. The most recent letter also noted that, two years ago, Tri-Med recalled gas relief drops for infants due to microbial contamination. So I guess that after 13 years, someone decided it was time to take action. During those 13 years, however, the company was allowed to put adulterated products in the market placing customers of all ages at risk of injury without oversight. Tort reformers and the pharmeutical industry constantly argue we should not allow state tort claims under the preemption doctrine because we need to trust the federal government agencies who are "the experts" at deciding what is safe for us. We can't trust the litigation system to do this, they say. With stories like this one and many others over the years about the deficiencies of the FDA as an oversight agency (see here and here, for example) , I think this is a difficult argument to make. For more details and links to relevant documents go to Pharmalot.