FDA Warning Letter Issued for "Objectionable Conditions Observed" during inspection!


A warning letter issued by Director David Burrow, Pharm.D., J.D. of the U.S. Food and Drug Administration to Gregory J. Tracey, M.D. informs Dr. Tracey of the “objectionable conditions observed during” the course of an FDA inspection conducted at his clinical site between March 25 and April 15, 2015.

Two FDA representatives, Ms. Jonee J. Mearns and Ms. Byungja E. Marciante, reviewed Dr. Tracey’s conduct in adherence to Protocol (b)(4), clinical investigations. Protocol (b)(4) “specifies that subjects with a positive serum pregnancy test at screening or at check-in will not be included in the trial, and requires that you [Dr. Tracey] or [his] designee verify that subjects meet all eligibility criteria at screening and at check-in.”

These requirements were neither met nor respected when Dr. Tracey’s site enrolled “Subject 1214, a 22-year-old female of childbearing potential, with positive serum pregnancy tests at screening and at check-in” into the study. Clinical investigators are required to ensure any and all investigations strictly follow the investigational plan. Subject 1214 did not meet the eligibility criteria, and thus should not have been enrolled in the study. 

On December 4, 2014, Subject 1214’s screening laboratory report showed that the subject’s serum human chorionic gonadotropin (hCG) level was 70.8 mIU/mL. The laboratory reports had clearly stated that any values above 5.2 mIU/mL are indicative of pregnancy.

Dr. Tracey signed the laboratory report and the subject was then rescreened on December 19, 2014 where her hCG level was 34,833.0 mIU/mL – considerably above the reference hCG level. Dr. Tracey also signed this report on December 22, 2014.

On January 5, 2015, Dr. Tracey signed a statement saying he had examined the inclusion/exclusion criteria and that the subject’s records had been thoroughly reviewed. This determination of eligibility “was contrary to the protocol,” because the records signed by Dr. Tracey indicated Subject 1214 “had a positive serum pregnancy test at screening, at rescreening, and at check-in.”

In an attempt to address this egregious enrollment error, Dr. Tracey “stated that the laboratory has now agreed to flag all elevated serum hCG results, and to place elevated results in a separate column, printed in red ink.” In the warning letter to Dr. Tracey, Director Burrow describes such tactics as insufficient and that Dr. Tracey’s “response is inadequate because your corrective action plan is not sufficiently detailed.” It is unclear whether these corrective actions will help to prevent “similar violations in the future.”

The most important takeaway of this warning letter is the fact that Dr. Tracey ignored the participant’s data being presented to him. Dr. Tracey fell into the trap of checking off the box without taking the time to look at the data presented and realize this glaring significant violation of the protocol.

It is the site’s responsibility to follow FDA regulations – not as guidelines, but as strict directives for how to properly and humanely manage a site and the enrollment of subjects. Hopefully this can serve as an example for future studies and site enrollments to not overlook empirical data. For the safety of the volunteers and all involved – this is crucial.