FDA warns Columbia over radioactive drug violations
The letter, written by Leslie K. Ball, MD, acting director at the Office of Scientific Investigations at the FDA, and addressed to G. Michael Purdy, PhD, executive vice president for research at Columbia, emphasized five areas where the RDRC failed to meet necessary conditions:
- The RDRC failed to assure the quality of radioactive drugs.
- The RDRC failed to assure that investigators immediately report all adverse events associated with the use of a radioactive drug in research.
- The RDRC failed to review and approve research at meetings at which a quorum was present.
- The RDRC failed to submit a special summary report to the FDA immediately after approving research proposals which involve exposure of more than thirty research subjects.
- The RDRC failed to assure research was reviewed and approved by an institutional review board.
“This letter is not intended to be an all-inclusive list of deficiencies related to the RDRC,” wrote Ball. “The inspection of the RDRC identified serious regulatory violations that have an impact on the RDRC’s protection of research subjects’ safety.”
An inspection in May prompted Columbia to respond to the FDA by promising “significant changes” to the standard operating procedures at the RDRC. The FDA, though, said the response was inadequate since the RDRC did not include written copies of the new operating procedures or indicate when corrective action would be undertaken.
Ball said FDA inspections also revealed that adverse effects did occur during research, but were not reported to the RDRC for review.
The letter also listed numerous examples of RDRC meetings where protocols and procedures were discussed without the necessary 50 percent of membership being present.
The FDA had previously intervened in Columbia University Medical Center research in an episode referenced within the letter. In April 2010, the FDA placed on clinical hold all investigational new drugs using PET radioactive drugs manufactured at Kreitchman PET Center.
Ball said the RDRC has 15 business days after receipt of the letter to notify the FDA in writing of actions taken to prevent similar violations in the future. Failure to do so could result in additional regulatory action without notice.