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FIRST ANDAs FILED LEAD TO 63% OF FIRST GENERIC APPROVALS, FDA FIVE-YEAR STUDY FINDS; AVERAGE ANDA TOOK 14.5 MONTHS AND 3.3 REVIEW CYCLES TO APPROVAL

Executive Summary

The first drug sponsors to file ANDAs received the first generic approval 63% of the time, according to a recently completed FDA analysis of the non-antibiotic drug workload and output at the Division of Generic Drugs. The FDA study, which analyzed first-time generic approvals among the 13 sponsors with five or more ANDA approvals over the past five years, found that 73 of 115 a first applications received first approvals. The analysis of ANDA review activities, begun at the request of the new generics division management in early 1989, was conducted by FDA Office of Planning and Evaluation analyst Dennis Hill. For the analysis, Hill chose a five-year study period extending from 1984 to 1989 for which a computerized database was available. Of the 13 sponsors considered in the study, Quad Pharmaceuticals and Pharmaceutical Basics, Inc. had the most "first in/first out" ANDAs, with 11 and 12, respectively. Quad and PBI also led in total first approvals, ("first in/first out" plus "not first in/first out") with 15 and 14, respectively. Both firms later were implicated in connection with the payment of illegal gratuities to former FDAers and cited for recordkeeping problems uncovered during FDA's inspection dragnet. Quad was cited by FDA for falsifying information in ANDAs. Bolar and Vitarine, two companies named in the generic drug scandal for fraudulent submissions, had five and three "first in/first out" ANDAs, respectively, the analysis shows. Vitarine also had six "not first in/first out" ANDAs. Par, another firm targeted in the FDA investigations, led in "not first in/first out" approvals with seven. Two "whistleblower" firms, Mylan and Barr Labs, had five and six "first in/first out" ANDAs, respectively. During the study period, 4,345 original ANDAs were received by FDA, an average of approximately 915 a year, with the greatest number received per month between October 1985 and March 1986. Of the applications received, 1,975, or 45%, were approved, 1,028 (24%) were not approved, 1,102 (23%) remained pending review, 298 (7%) were withdrawn, and 32 (1%) were classified "other." FDA said: "Given enough time, roughly 70% of the ANDAs submitted in any given calendar quarter are eventually approved." FDA also looked at the number of review cycles ANDAs undergo before approval. A "review cycle" is defined by the agency as beginning with FDA's issuance of an action letter and ending "with FDA's issuance of a second action letter after evaluation of the applicant's response to the first letter." Approximately one-half of the ANDAs submitted were approved by the end of the third review cycle (that is, two not-approvable letters had been issued). Additionally, 80% of the ANDAs were approved within four review cycles. Regarding time to approval, the study found that "it took about as long to approve an application from a sponsor who had many approvals as it did to approve an application from a sponsor who had few approvals." A first review cycle was found to average 4.5 months, with subsequent cycles averaging 2-3 months. The average number of months to approval of ANDAs submitted was 14.5 months. Among the 38 firms [with 10 or more approvals during the five-year period], American Therapeutics received the quickest approvals, averaging about eight months of review time for applications approved during the five-year period. Also averaging less than twelve mean months to application approval were Interpharm, Purepac, Mutual, and Duramed. Pioneer Pharmaceuticals' approvals came slowest, averaging about 24 months. Other firms with more than 18 mean months per application were Abbott, Bolar, Steris Lab, and Pharmaceutical Basics. During the study time period, the amount of original ANDAs under review or awaiting review, including resubmissions, "increased steadily from July 1988 (approximately 700) to August 1989 (approximately 1,000), then remained fairly constant from August 1989 to January 1990." The number of pending ANDA supplements, including resubmissions, remained about even "from October 1987 (approximately 1,250) to May 1989," the study says, adding that the number then "more than doubled by January 1990 (approximately 2,800)."

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