CIS/Index
Copyright © 1999, Congressional Information
Service, Inc.
1 CIS S 5218
TITLE: Pipeline Drugs:
Proposed Remedies for Relief in the Drug Patent Term Restoration Review
Procedure Act of 1999
CIS-NO: 2001-S521-8
SOURCE: Committee
on the Judiciary. Senate
DOC-TYPE: Hearing Retrieve
the full text of testimony
DOC-NO: S. Hrg. 106-772
DATE: Aug. 4, 1999
LENGTH: iv+124 p. il.
CONG-SESS:
106-1
ITEM-NO: 1042-A; 1042-B
SUDOC:
Y4.J89/2:S.HRG.106-772
CIS DOCUMENT ON DEMAND: 1-800-227-2477 (Full
Text Reproductions)
GPO-STOCK-NO: 552-070-26298-9.
SUMMARY:
Committee Serial No. J-106-44. Hearing to
consider S. 1172 (text, p. 4-18), the Drug Patent Term Restoration Review
Procedure Act of 1999, to amend the Federal Food, Drug, and Cosmetic Act to
establish an administrative process for Patent and Trademark Office review of
drug company requests to extend patents for certain drugs for which an
investigational new drug application had been submitted to FDA prior to
enactment of the Drug Price Competition and Patent Term Restoration Act of 1984,
also known as the Hatch-Waxman Act. Purpose of bill is to
permit certain drug companies to receive a patent term extension to compensate
for delays in FDA completion of the drug approval process.
Supplementary material (p. 20-21, 79-124) includes submitted statements and:
-- Schondelmeyer, Stephen W., "Patent Extension of
Pipeline Drugs: Impact on U.S. Health Care Expenditures" with tables and graphs
(p. 85-121).
CONTENT-NOTATION: Drug patent process
revision
BILLS: 106
S. 1172
DESCRIPTORS:
FOOD AND DRUG ADMINISTRATION; MEDICAL REGULATION; PHARMACEUTICAL INDUSTRY;
GOVERNMENT AND BUSINESS; MEDICAL ECONOMICS; STATISTICAL DATA: HEALTH AND VITAL
STATISTICS; STATISTICAL DATA: INDUSTRY AND COMMERCE; DRUG PATENT TERM
RESTORATION REVIEW PROCEDURE ACT; FEDERAL FOOD, DRUG, AND COSMETIC ACT; PATENT
AND TRADEMARK OFFICE; PATENTS; DRUGS; DRUG PRICE COMPETITION AND PATENT TERM
RESTORATION ACT
01-S521-8 TESTIMONY NO: 1 Aug. 4,
1999 p. 25-77
WITNESSES (and witness notations):
METZENBAUM, HOWARD M. (Chairman, Consumer Federation)
KOGAN, RICHARD J. (Chairman and CEO, Schering-Plough Corp)
MEYER, GERALD F. (former Associate Commissioner, FDA)
BEN-MAIMON, CAROLE S. (Dr.) (Senior Vice President,
R&D and Scientific Affairs, Teva Pharmaceuticals)
HUTT, PETER B. (attorney)
DOWNEY,
BRUCE L. (Chairman, Barr Laboratories)
STATEMENTS AND DISCUSSION:
Opposing views on S. 1172; unfairness of S. 1172 to
consumers and generic drug industry; importance of bill to certain drug
manufacturers seeking to recover R&D expenses; perspectives on FDA drug
review and approval process.
Need for S. 1172 to
compensate certain drug manufacturers for delays in FDA completion of the drug
approval process; differing views on Schering-Plough Corp. efforts to extend
patent term for loratadine, an antihistamine marketed as Claritin.
CONTENT NOTATION:
Drug patent process revision
TESTIMONY DESCRIPTORS:
CONSUMER FEDERATION;
CONSUMERS; MEDICAL RESEARCH; ANTIHISTAMINES; LORATADINE
LOAD-DATE: May 23, 2001 
