Continuous Marketing Applications: Experiences of Three Biotechnology Companies
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Christine Boisclair, BS' OSI Pharmaceuticals Inc.. Melville, New York Mag Casais, MA Eyetech Pharmaceuticals Inc.. Cedar Knolls. New Jersey MaryAnn Foote, PhD Julie Lapin, BS Jenny Peters, BS, RPh Amgen Inc., Thousand Oaks. California
Donno Peterson, AB Amgen Inc.. Washington, DC 'All authors contributed equally and are listed in alphabetical order.
Key Words Fast track; NDA: PDLJFA: Reviewable units Correspondence Address Christine Boisclair OSI Pharmaceuticals Inc.. 41 Pinelawn Road, Melville, N Y 11747 (e-mail: [email protected]). MaryAnn Foote. PhD, currently is Vice President, Medical Writing, American BioScience, lnc.. Santa Monica, California.
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Continuous Marketing Applications: Experiences of Three Biotechnology Companies h e continuous marketing application, pilot 1 of the Prescription Dug User Fee Act 3, is a progmm available for drugs and bidogics that have received fast-tmck designation. The appliation allows for submission of reviewable units with the goal of enabling new, innovative thempies for severe and life-threatening illnesses to gain marketing approval fastex hree biotechndogy products have been approved under this progmm. Two companies submitted two reviewable units, and one company submittedfive reviewable units. In each case, the units were sub-
I NTR 0 D U CTI 0 N The Prescription Drug User Fee Act (PDUFA) was reauthorized for a second time on June 12, 2002, as PDUFA 3 (1).A nonlegislativecompanion document, known as the goals letter, details the program and the metrics associated with the fiscal years (October 1 to September 30) 2003 to 2007. Included in PDUFA 3 are pilot 1and pilot 2 of the continuous marketing application. The pilot programs are available only for drugs that are granted fast-track status (that is, drugs that provide a "therapeutic advance"). Pilot 1 tested the continuous marketing application concept for the review process for new drug applications (NDAs) and biologic licensing applications (BLAs) (2). The continuous marketing application concept builds on the current practice of interaction between the Food and Drug Administration (FDA) and an applicant during the drug development phase and application review and proposes improvements in the processes. Specifically,pilot 1 provides for the review of a limited number of presubmitted portions of an applicant's marketing application (reviewable units) based on the terms and conditions agreed to by the applicant and the FDA. After 6 months, the pilot provides feedback from the FDA in the form of discipline review letters. The
mitted rapidly so that the time between the submission of the first and final units was appmimat@ 6 months. The continuous marketingapplication was useful but required precise planning and ongoing discussion with the Foal and Drug Administmtion. Because the progmm was a pilot program, some recommendations are given to improve its utility 'Ihe three companies would be willing to use pilot 1 again based on resource allocation benejits for the company and potential staggering of comments from
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