Faster Access to Drugs for Serious or Life-Threatening Illnesses Through use of the Accelerated Approval Regulation in t
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FASTER ACCESS TO DRUGS FOR SERIOUS OR LIFE-THREATENING ILLNESSES THROUGH USE OF THE ACCELERATED APPROVAL REGULATION IN THE UNITED STATES DAVIDM. COCCHETTO, PHD, AND DOUGLAS R. JONES Regulatory Affairs, Glaxo Wellcome Inc., Research Triangle Park, North Carolina
The Food and Drug Administration issued a final regulation on accelerated approval for human drugs, antibiotics, and biologics on December 11, 1992. This regulation provided a formal regulatory mechanism for a sponsor to seek accelerated approval by submitting a New Drug Application for a drug intended to treat a serious or life-threatening illness. In order to qualify for accelerated approval, a drug must seek an indication for an illness having either a surrogate endpoint which is reasonably likely to predict clinical benefit or a reliable clinical endpoint other than survival or irreversible morbidity. This important and much needed regulation has been used to achieve accelerated approval of several antiretroviral and oncology drugs, as well as several other drugs and biologics. Since this regulation has been in place for almost five years, the purpose of this paper is to summarize all of the drugs that have utilized this regulatory mechanism to attain approval in the United States. From 1992 through the end of July 1997, a total of 20 drugs have received accelerated approval. This summary of these drugs shows that this regulation has been a successful means of providing more rapid regulatory review and approval for drugs intended to treat a serious or life-threatening illness. Regulatory affairsprofessionals should be familiar with the precedents for approval of drugs under this regulation, both to enable them tofollow well-trodden paths and to consider extending the experience to drugs for other indications under appropriate circumstances. Key Words: Accelerated approval; Regulatory affairs; Serious or life-threateningillnesses; United States
IN 1992, THE UNITED STATES Food and Drug Administration (FDA) created a mechanism for accelerating the regulatory approval of drugs for the treatment of certain serious or life-threatening illnesses. The proposed regulation was published in the Federal Register on April 15,1992 (1) and it was adopted
as a final rule on December 11, 1992 (2). The accelerated approval regulation was developed under the leadership of Dr. David Kessler who, at that time, was Commissioner of Food and Drugs. This regulation was an innovative, yet measured, response to the increasing need for regulatory procedures that could facilitate efforts to develop and assess new treatments for serious or life-threatening diseases* Some Of drugs that can use this regulatory me~hanismare treatments for HIV infection, cancer, advanced multiple
Reprint address: David M. Cocchetto, PhD, Glaxo Wellcome Inc., 5 Moore Drive, Research Triangle Park, NC 27709.
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David M. Cocchetto and Douglas R. Jones
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