FDA did not post any warning letters to Sponsors/Monitors/CROs, Clinical Investigators or IRBs this week. From the archives, here is the Clinical Inspection Summary for Austedo (deutetrabenazine) submitted by Teva. Two of the thirty participating sites in the study were selected for inspection based on high enrollment and impact on decision making for approval. FDA notes that a statistical methodology was used for site selection. Site inspections ranged over four to eighteen days. One site received a FDA Form 483.
Dr. Claassen was cited for:
- Two subjects were unable to provide a required blood sample at one visit and the site made arrangements for them to return another date to provide the sample. (Note: The FDA reviewer indicates that the inability to draw blood is understandable and that the action taken in response to the protocol deviation was acceptable.)
- One subject's medical records indicated excessive alcohol consumption and an attempt to reduce alcohol intake to six beers a week, plus marijuana use on Fridays. FDA notes that this marijuana and alcohol use violate two of the eligibility criteria for the study.
- Study records for one subject indicated no alcohol use at screening, but two months after screening this was changed to indicate alcohol use. Additionally, three months after screening the amount of alcohol used per week was changed from 1 beer per week to four beers per week with no explanation.
Note: FDA meetings with the sponsor indicate a concern about alcohol's effect on the activity of the study drug. Study exclusion criteria addressed this.
The other site that was inspected did not receive a FDA Form 483, but the inspection summary notes issues of prepopulation of some forms to "save time", write overs and inadequate source documentation for some visits.