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FDA ANDA REVIEWS ARE KEEPING PACE WITH APPLICATIONS: 246 ANDAs APPROVED FROM OCTOBER THRU DECEMBER; TOO MANY BULK REFERENCES CAN SLOW APPROVAL

Executive Summary

FDA approved 244 ANDAs during the final quarter of calendar 1987, almost keeping pace with the number of submissions (260), FDA Generic Drugs Division Director Marvin Seife, MD, told the National Association of Pharmaceutical Manufacturers (NAPM) annual meeting in Puerto Rico, Jan. 19. During the first year of implementation of the Waxman/Hatch law, fewer than half the ANDA applications received by FDA were approved by the generic division. The division received 1,159 applications during fiscal 1985 and approved 461. In fiscal 1986, the number of ANDAs remained almost constant at 1,168, while the number of approvals rose to 683. In fiscal 1987, the number of applications declined slightly to 1,111 versus a further rise in approvals to 744. If the rapid pace set during the first quarter continues, the agency could approve more than 1,000 ANDAs this year. Almost twice as many post-1962 ANDAs as pre-1962 ANDAs have been approved since Waxman/Hatch was enacted. Of the total number approved, 1,195 were post-62 ANDAs, 699 pre-1962 applications, and 242 were antibiotics. Along with the significant increase in the rate of approvals by his division, Seife pointed to the dramatic increase over the last year in the number of different post-1962 drug entites which have received ANDA approval. Among the 1,195, which were approved as of Dec. 31, Seife reported that there were "104 different drug entities or more than double the 46 entities approved a year earlier." Seife noted that 80 different pharmaceutical firms have now received one or more post-1962 ANDA approvals. While one firm has received approval for 30 different entities and several other firms for more than 20, three-quarters of the firms have received approval for nine or fewer entities. The increases in the ANDA approval rate by the generic division may also reflect growing familiarity with FDA expectations by bulk drug suppliers of ANDA applicants and growing confidence by FDA in those bulk suppliers. "It looks like somebody's getting the message out there because we are getting an improvement in the bulk drug samples being submitted," FDA Center for Drug Analysis Director Tom Layloff told the NAPM meeting. Layloff noted that out of 147 ANDA bulk drug samples submitted to his laboratory during the first three months of fiscal 1988 only one failed to pass the agency's testing requirements. Generic Division Director Seife cautioned the generic group that applications can be significantly delayed by listing too many bulk suppliers in the ANDA or by including firms that have not been previously reviewed by FDA. Seife noted that several recent applications have listed as many as six or seven suppliers, some of which have never been inspected. Reviewing such applications, Seife noted, "is a long involved process." Seife advised the manufacturers of particular finished dosage forms instead "to have two suppliers of known quality and do your studies with them, etc., and not drag the whole approval process out while we investigate seven alternate suppliers." Firms wanting a variety of alternate suppliers, Seife advised, "should wait until after approval of that product and then put them in a supplement where you can afford to wait for us to get the necessary checks."
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