FDA Warns California Ophthalmologist Again Over Clinical Trial Violations
Posted 02 December 2015 | By
For the second time since 2000, the US Food and Drug Administration (FDA) has sent a warning letter to a Newport Beach, California-based ophthalmologist over objections to a clinical trial run by him.
The latest letter, released Tuesday, claims that Dr. Thomas Tooma of the NVISION Laser Eye Centers ran a clinical trial at seven sites with an unapproved drug without first submitting an investigational new drug (IND) application to FDA as required by law.
“Your investigational drug, riboflavin ophthalmic solution, is not a lawfully marketed drug product in the United States, nor is it exempt from IND requirements. As a result, before using riboflavin ophthalmic solution in a clinical investigation, you were required to submit an IND for the drug to FDA,” the agency says following inspections of Tooma’s clinical trial site in June and July.
Tooma also claims to have performed surgeries “for humanitarian/compassionate-use purposes” and submitted trial protocols and patient informed consent documents to an institutional review board (IRB), which did not inform Tooma that an IND was required to conduct the study.
He also previously acknowledged to FDA that the trial did not have a monitor and he told the agency he would hire one, but he then failed to provide a “proposed monitoring plan, including a timeline for when the experienced monitor would be hired.”
In addition, according to FDA, Tooma failed to maintain drug disposition records for any of the subjects at the seven study sites who underwent corneal cross-linking and received riboflavin ophthalmic solution in one or both eyes.
2000 Warning Letter
The contents of the 2015 FDA letter seems to suggest that the trial might have been Tooma’s first, which is why he violated the law.
But another FDA warning letter from April 2000 details Tooma’s failure to conduct a different trial in accordance with an investigational plan, particularly in regard to adhering to inclusion/exclusion criteria from the trial protocol.
More specifically, FDA notes the case of several patients leaving the study because of their impatience in waiting for an enhancement surgery. “Of the subject files reviewed, three subjects received enhancements outside of the study, after exiting the study,” though in all three cases, the date for their exit and the enhancement surgeries are the same, FDA says.
“Moreover, the inspection report notes that the sponsor had notified you in a letter dated October 13, 1999, that the use of other laser systems for retreatment was inappropriate. To have done so for any study subjects, even those who officially exited the study, indicates that your intentions as a clinical investigator differ from what is expected by both the sponsor and FDA,” the report says.
FDA also warns Tooma for failing to follow the general requirements for obtaining informed consent.
“You stated that employees designated to administer the informed consent process were not qualified to review the patient’s medical history record and would not know of the subject’s prior surgery. Item 4 on the investigator agreement states, ‘The full responsibility for administering adequate informed consent rests entirely and exclusively with the surgeon,’” FDA adds.
Tooma did not respond to a request for comment from Focus.
FDA Warning Letter from November 2015
FDA Warning Letter from April 2000