Executive Summary

CHINOIN IS SOURCE OF BULK NYSTATIN SUPPLIED TO QUANTUM by Issac Bulka, according to a Feb. 5 letter from Bulka to Rep. Dingell's (D-Mich.) House Oversight Subcommittee staff. "Isaac Bulka and Pan American Medical Supply Inc. delivered Nystatin to Quantum Pharmics, which was strictly and unequivocally manufactured by Chinoin," Bulka wrote. "Documentary proof positive of this is being submitted to FDA for their evaluation." Bulka was replying to a letter to the congressman by Agvar, Chinoin's sole authorized U.S. distributor for the bulk antifungal product. Agvar maintained that neither it nor Chinoin sold nystatin to Quantum, which recalled finished product made from the bulk due to subpotency ("The Pink Sheet" Jan. 29, p. 4). Bulka said: "There has never been any question of any product we sold to Quantum as to its quality, conformance with USP or potency. To the best of my knowledge, it is Quantum's internal policy not to complete payment until [the] product is assayed. That was the case with all the shipments of nystatin that we made to their firm." The distributor called Agvar's reference to a delivery of the bulk product in a car trunk "malicious and slanderous." Bulka reported that "on one occasion I did pick up several drums of nystatin directly from the customs warehouse at [New York's] JFK airport and delivered said product straight to Quantum's facility, which is less than 45 minutes' travel time away in an air-conditioned vehicle. This definitely refutes the sinister implications of product being delivered 'from the back of the car for cash payments,'" he asserted. Suggesting that Agvar's price for nystatin is much higher than the price for the same Chinoin product overseas, Bulka wrote: "Those distributors that charge a fair price, consistent with those that are available worldwide, are generally not seriously vulnerable to pricing competition from other suppliers." Bulka expects to meet with Dingell subcommittee staff "within the next few weeks."