FDA disciplines cancer center

The Food and Drug Administration has suspended clinical trials at the Belleville, NJ-based Garden State Cancer Center until violations at the center, documented in a Sept. 19 letter to the center's President, David Goldenberg, are addressed.

The letter cited four specific violations of FDA regulations:

•Â Failure to submit an investigational new drug application to the FDA and failure to withhold administration of an investigational new drug until an IND was in effect.

•Â Failure to ensure proper monitoring of the investigation and failure to ensure that it was conducted in accordance with the general investigational plan and protocols contained in the IND.

•Â Failure to maintain adequate records showing the receipt, shipment or other disposition of the investigational drug and failure to ensure the return of all used supplies of the investigational drug or to ensure alternative disposition of unused supplies of the investigational drug.

•Â Failure to obtain prior written approval of the FDA before charging for investigational drugs.

Goldenberg defended the cancer center and said the mistakes had all been fixed. "The cases to which the FDA letter referred all occurred before March 1995. Through that date, the center had been operating its investigational trials under the auspices of an in-house review board. When the practice came to the attention of the FDA during a routine inspection in 1995, it was agreed that all future trials would require submission of an investigational new drug application to the FDA. Since that time, every investigational trial at Garden State Cancer Center has been conducted under the auspices of an IND."

Goldenberg also characterized the FDA's alleged violations as paperwork errors and rushed to assure the Garden State Cancer Center's patients that the quality of their care was not an issue. "We believe that virtually all of the issues raised by the FDA involve paperwork and record-keeping deficiencies, not treatment," he said. "We are confident that our patients have been treated with the highest level of professionalism, safety and concern for their welfare." PR