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 BETHESDA, Md., May 8 /PRNewswire/ -- The Hyatt Regency was the site of a two-day workshop, April 15-16, sponsored by the Technical Committee of the National Association of Pharmaceutical Manufacturers (NAPM) with the assistance of the Food and Drug Administration (FDA).
 NAPM is the leading voice of the generic pharmaceutical industry and the largest trade organization representing manufacturers and distributors of generic drugs in the United States.
 This conference marked a record-high level of interaction between FDA staff and members of the pharmaceutical industry in a meaningful public exchange on the FDA approval process to bring generic drugs to market, specifically the ANDA (Abbreviated New Drug Application) process. The ANDA procedure allows generic versions of more expensive brand-name drug products whose patents have expired to be approved for marketing. These generic products must be shown to be pharmaceutically equivalent and bioequivalent.
 Part of a continuing series sponsored by NAPM, the seminar was open to the entire pharmaceutical industry. Approximately 270 people attended, including about 30 FDA staffers and more than 30 representatives from about 20 companies traditionally considered "brand- name" manufacturers. The conference featured noted speakers from regulatory agencies, the academic arena, and the pharmaceutical industry.
 NAPM Chairman Michael Reicher opened the program by stating the objective of the workshop: "to establish a good, solid, public dialogue between the generic pharmaceutical industry and the FDA to communicate mutual concerns and ideas and to hopefully find mutual solutions."
 Reicher speculated that the $18-$20 billion in sales of drugs going off patent in the next few years could produce generic products that would save the public $8-$10 billion a year. In order for these alternatives to be available to the public, he said, a more efficient approval system is needed to bring safe, effective, economical generic drugs to the market as quickly as possible.
 Gerald F. Meyer, deputy director of the FDA's Center for Drug Evaluation and Research, agreed with Reicher's statement regarding the need for a refined approval process, and maintained that an improvement in the quality of the applications submitted would help to expedite the process.
 In speaking of Roger L. Williams, M.D., director of the FDA's Office of Generic Drugs, Meyer said, "He brings a refreshing openness and honest challenge to what we do at the Agency. He questions our traditions, our policies: does what we do make sense, is this really the best way to measure this item? He wants to make sure our policies focus on important issues and the need to work together for the efficient development of safe and effective drugs."
 In his presentation, Williams he referred to what he coined as the "one-shot ANDA": the submission of a generic drug application of such high quality that after the recommendations from the initial review had been addressed, the application would be approved after a second review. Williams' objective for the FDA is to work together with the pharmaceutical industry to establish this high level of submission quality and to achieve the goal of the "one-shot ANDA."
 Williams and his staff also are working toward a policy of "early rejection" of poorly executed generic drug approval submissions. Instead of waiting 8-10 months to reject an obviously flawed application, Williams would like to dismiss it as part of a "first cut" and save reviewers and applicants a great deal of time.
 Williams noted that he takes great professional satisfaction in seeing the pharmaceutical industry and the FDA work together. If communication between the two were further strengthened, there would be an even greater chance of applications being corrected after the initial review process.
 In a panel discussion on Regulatory Responsibility & Ethics in ANDA Preparation, Daniel L. Michels, director of FDA's Office of Compliance, echoed Williams' sentiments regarding the "one-shot" ANDA. He further defined the term as "doing the job right," and reiterated that increased communication is the key to the success of this policy. To reduce the possibility of wrongdoing, Michels advised companies to "do it right the first time" by employing a system to address all submission requirements to ensure that all product development and generic drug approval submission activities are high-quality operations.
 Milton Bass, of Bass & Ullman, general counsel to NAPM, discussed the legal importance for pharmaceutical companies to conduct internal audits of all procedures pertaining to ANDA submissions. He suggested that there should be a written standard operating procedure for an internal audit and documentation that all steps have been followed during the entire submission process. He urged heads of companies to be vigilant, not complacent. "Know what you are signing and be certain that it is correct," he asserted, and Michels strongly concurred.
 During the remainder of the meeting, a number of FDA staffers addressed questions from the audience. Other subjects discussed included Good Manufacturing Practice, pre- and post-approval inspections, and regulatory issues governing generic drug approval submissions.
 The atmosphere throughout the two-day workshop was one of professionalism, respect, and mutual concern to increase cooperation for the benefit of the general public. All parties agreed that open communication is the key to a more efficient ANDA approval process.
 A more effective generic drug approval process, as concluded by all present, brings tremendous potential benefit to both the consumer and the pharmacist: more expedient arrival of safe, effective, and economical drugs on the market. The opportunity for the general public to use these drugs could reduce annual healthcare costs by billions of dollars.
 -0- 5/8/92
 /CONTACT: Michael K. Reicher, chairman, or Robert S. Milanese, president of the National Association of Pharmaceutical Manufacturers (NAPM), 212-838-3720/ CO: National Association of Pharmaceutical Manufacturers ST: Maryland IN: MTC SU:

SM-TS -- NY029 -- 8038 05/08/92 11:03 EDT
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Date:May 8, 1992

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