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Executive Summary

FDA's ANDA approval rate will not increase dramatically in the near term, despite efforts to make the review process more efficient, the Office of Generic Drugs predicted in a response to the "Kibbe" report on the generic drug review process by independent consultants. Dated June 20 and submitted to the House Energy & Commerce/Oversight Subcommittee July 19, the response explains: "With current and future anticipated workload and resources, coupled with more stringent review requirements, it is not likely that dramatic changes in output will occur in the short term." The generics office noted it "does not intend to move applications forward at the expense of quality and consistency, nor are inspection requirements likely to lessen in the immediate future." The response adds that faster generic drug approvals will require "improved quality of applications," increased resources, "improved management of document and information flow" and "improved communications" between headquarters and field investigators "regarding the review and inspection processes." The agency office was responding to the review of its operations by three outside consultants: American Pharmaceutical Association official Arthur Kibbe, PhD, pharmaceutical industry consultant John Zarembo, PhD, and HHS Inspector General Special Agent James Kopf. They presented their findings orally to the subcommittee at a June 5 hearing ("The Pink Sheet" June 10, p. 10). Suspected fraud on the part of ANDA sponsors is part of the reason for delays in approvals, the response states. "As many as 36% of pending unapproved applications and 48% of pending unapproved supplements have been or could be potentially delayed because they have been submitted by firms suspected or confirmed of having engaged in fraudulent conduct or because there are problems with GMP compliance." The response notes that 53 generic drug marketing applications were recommended for approval by FDA chemists as of May 24, 1991. Ten of those applications (19%) are "under suspicion of fraud," two (4%) received a "field recommendation to withhold approval," five (9%) are awaiting field audits, 32 (60%) are awaiting clearance from the field and four (8%) are awaiting final clearance from the Office of Generic Drugs. Pre-approval inspections by FDA's field force also have uncovered reasons to delay generic drug approvals, the office maintained. Field inspections "may . . . become the rate-limiting step" in the approval process, the response suggests. The inspections "often" identify "deficiencies in compliance with GMP [good manufacturing practice regulatory] requirements that must be corrected and verified by reinspection before [approvals] can be granted," the response notes. FDA added that as of April 1991, "compliance and field enforcement efforts have resulted in several referrals for prosecution" to the Justice Department. The response also reports that FDA has proposed to withdraw "at least 130 separate approved ANDAs produced by 11 firms," and its enforcement program has led to 411 product recalls and "cessation or curtailment" of production by eight pharmaceutical firms. To improve the quality of companies' marketing applications, the office said it will hold "several" workshops with industry "to discuss review requirements." The response points out that the office in September 1990 held an industry workshop on "the most common chemistry and manufacturing deficiencies found in ANDAs" and currently is studying common labeling deficiencies. In addition, the office said it is planning "workshops on batch scale-up, miscellaneous manufacturing issues and sterility issues." FDA also is considering compiling all its guidelines on generic marketing applications into "one procedure manual for generic drug applicants," the response states. The office "has issued 30 policy and procedure guides providing information on a variety of subjects, including how to improve ANDA quality, batch- size and manufacturing requirements for non-antibiotic solid oral dosage forms drug products supporting proposed ANDAs, and submission of reprocessing procedures."

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