The non-profit Project on Government Oversight (POGO) Issued a devastating report today on the failure of FDA’s Center for Devices and Radiological Health to enforce the Good Laboratory Practice (GLP) regulations. You can find the report on the Blogroll to the right. You can also read the Reuters article on the controversy. But let’s look briefly what is at stake. And you can read my take on it all right below.
I used to conduct GLP inspections. In fact, the last FDA Warning Letter to a non-clinical laboratory conducting medical device studies was issued in July 2004 as a result of my last GLP inspection. What are the GLPs and why are they so important?
The GLP regulations came into being in 1979 as a result of a series of scandals involving fraudulent data submitted to the Agency in the 1970s. As a result, regulations required non-clinical laboratories to conduct certain activities to ensure data integrity. And they required inspections to make certain the regulations were followed. Besides such obvious things such as the calibration of equipment, the GLPs offered three important elements that changed the way safety studies are conducted.
First, the regulations required a “single point of control,” i.e, a study director who had responsibilities that exceed those of an academic principal investigator. The study director is required to follow the protocol and make sure that a final report is issued according to FDA criteria.
Second, GLPs require that the data are reviewed by a “quality assurance unit” or QAU. The QAU needs to document what study activities are reviewed. Most do an excellent job and belong to professional organizations like the Society of Quality Assurance (SQA), an organization that I belong to as well.
Third the GLPs require the retention of archives so the study can be verified. There’s a lot more but these three things make the GLPs necessary for protecting the public health. So when a CDRH representative told the May 2007 annual meeting of SQA that the GLPs were no longer necessary, the place was stunned into silence. Something was very wrong.
To their credit, FDA professionals strongly objected to the policy. They did what public officials should do: Speak Up. Now it appears someone is listening. What remains to be seen is what will happen. Your guess is as good as mine.