FDA GCP Inspections July 21, 2010Posted by Michael Hamrell in Regulatory Thoughts.
The Food and Drug Administration has recently updated its Information Sheet Guidance on inspections of clinical investigators. This guidance updates their existing policy on GCP inspections and reiterates the expectations during an inspection. It also discusses the differences and similarities between inspections for drug and biologic products and medical device studies. The goal of the inspections are basically the same; to confirm the validity of the submitted data and confirm that the study was conducted according to the regulations. The Guidance also discusses intenrational inspections and confirms what has been long known, that FDA will inspect a study when the studies are part of a marketing application submitted to FDA and provide data critical to decision-making on product approval. One difference you will note is that the regulations for drugs and biologics require that the study be conducted according to Good Clinical Practice, as defined in the regulations, while the device regulations require the study be conducted in accordance with the Declaration of Helsinki or the laws and regulations of the country, whichever provides more protection for human subjects.
The reference to the Declaration of Helsinki (DoH) has become an issue and controversy in recent years. The FDA device regulation refers to the 1983 version of the DoH. The FDA acknowledges that there have been subsequent revisions to the DoH (most recent in 2008), but they have not adopted the more recent versions. This does create some issue for multinational device companies, where their international colleagues reference the most recent version of the DoH, while the FDA only recognizes a 17 year old, outdated version. Some ask; does the FDA no longer subscribe to international ethical standards? The answer is a bit more complex than that, but in the end the FDA does endorse the principles of the DoH. They just prefer to express it in their own regulations, under their own control, and in their own way.
So fear not. The DoH is still a guiding document and standard.