MONOPOLY AND ANTICOMPETITIVE ACTIVITIES
SELECT COMMITTEE ON SMALL BUSINESS
UNITED STATES SENATE
PRESENT STATUS OF COMPETITION IN THE
PHARMACEUTICAL INDUSTRY
NOVEMBER 14, 15, AND 16, 1977
DRUG QUALITY, COMPETITION, AND
GOVERNMENT PROCUREMENT OF DRUGS
Printed for the use of the Select Committee on Small Business
U.S. GOVERNMENT PRINTING OFFICE
For sale by the Superintendent of Documents, U.S. Government Printing Office
Washington, D.C. 20402
Apple, Dr. William S., executive director of the American Pharma-
ceutical Association, accompanied by Dr. Edward G. Feldmann,
associate executive director for scientific affairs, APhA; and Carl
Roberts, associate general counsel, APhA.......
Boisseree, Victor R., chief, Volume Purchase Plan, California State De-
partment of Health..
Danielson, David A., Massachusetts Drug Formulary Commission,
Medical Assistance Division, Massachusetts Department of Public
Welfare
Gardner, Sherwin, Deputy Commissioner, Food and Drug Administra-
tion, accompanied by Richard Cooper, Chief Counsel, FDA; and
Frank Flaherty, Director, Medical Products Quality Assurance
Division, FDA..
Haddad, William F., director, Office of Legislative Oversight and
Analysis, New York State Assembly, Albany, N.Y.....
Kennedy, Hon. Donald, Ph. D., Commissioner, Food and Drug Ad-
ministration, accompanied by Richard Cooper, Chief Counsel, FDA;
and William W. Vodra, Associate Chief Counsel, FDA..
Marovitz, William, State representative from Chicago, Ill..
Stetler, C. Joseph, president, Pharmaceutical Manufacturers Associa-
tion, accompanied by Bruce J. Brennan, vice president and general
counsel, PMA; and Dr. John G. Adams, vice president, Scientific and
Professional Relations, PMA..
Wegner, Fred, legislative representative for pharmaceuticals of the
American Association of Retired Persons and the National Retired
Teachers Association.......
List of voluntary recalls conducted by the Food and Drug Administration,
1975-77 ---
Letter dated November 16, 1977, to Senator Gaylord Nelson, chairman,
Senate Small Business Committee, from Dr. William S. Apple, executive
director, American Pharmaceutical Association__.
Memorandum of agreement between the State of California Department
of Health and the Food and Drug Administration, February-March
1976__
Letter dated November 25, 1977, to Senator Gaylord Nelson, chairman,
Senate Small Business Committee, from Sherwin Gardner, Deputy
Commissioner, Food and Drug Administration.........
Letter dated dated December 1, 1977, to Senator Gaylord Nelson, chair-
man, Senate Small Business Committee, from C. Joseph Stetler, presi-
dent, Pharmaceutical Manufacturers Association__
MATERIAL SUPPLIED FOR THE RECORD BY THE SUBCOMMITTEE ON
MONOPOLY AND ANTICOMPETITIVE ACTIVITIES
Letter dated September 15, 1977, to Dr. Donald Kennedy, Commissioner,
Food and Drug Administration, from C. Joseph Stetler, president,
Pharmaceutical Manufacturers Association_
Letter dated January 26, 1977, to Martin Golden, State of Delaware, from
Dr. Bernard E. Cabana, Director, Division of Biopharmaceutics/Drug
Monographs, Bureau of Drugs FDA..
Speech, "Bioavailability/Bioequivalence Issues Concerning Drug Inter-
changeability," by Dr. Bernard E. Cabana, Director, Division of Bio-
pharmaceutics, Bureau of Drugs, FDA, June 8, 1977-
Letter dated May 23, 1977, to David E. Langdon, assistant director, Office
of Legislative Oversight and Analysis, New York State Assembly, from
Gene Knapp, Associate Director for Drug Monographs, Bureau of
Drugs, FDA
DOCUMENTS RELATING TO WINTHROP Drug Co.
Letter dated March 19, 1975, to Norman W. Lavy, M.D., E. R. Squibb &
Sons, Inc., from Alexander M. Schmidt, M.D., Čommissioner, Food and
Drug Administration..
Letter dated March 19, 1975, to B. G. Crouch, Ph. D., Sterling-Winthrop
Research Institute, from Alexander M. Schmidt, M.D., Commissioner,
Food and Drug Administration__
Memorandum dated March 19, 1975, from Alexander M. Schmidt, M.D.,
Commissioner, Food and Drug Administration.
Memorandum dated July 24, 1975, to the General Counsel, Food and Drug
Administration, from T. E. Byers.-
Memorandum of telephone conversation dated August 6, 1975, between
Dr. Billy Crouch and Roger Rodwin, Sterling Drug, Inc., and Edward G.
Seibert, Compliance Officer, Food and Drug Administration_
Letter dated September 9, 1975, to Dr. B. G. Crouch, Sterling Drug, Inc.,
from Edward G. Seibert, Compliance Officer, Food and Drug Administra-
tion_____
Memorandum dated September 29, 1975, to the Acting Associate Director
for New Drug Evaluation, FDA, from Frances O. Kelsey, M.D., Scientific
Investigations Staff, FDÁ..
Letter dated November 4, 1975, to B. G. Crouch, Ph. D., Sterling-Winthrop
Research Institute, from Carl M. Leventhal, M.D., Deputy Director,
Bureau of Drugs, FDA..
Letter dated November 4, 1975, to Seymour Weinstein, Esq., Burwick &
Burwick, from Carl M. Leventhal, M.D., Deputy Director, Bureau of
Drugs, FDA..........
Letter dated November 7, 1975, to B. G. Crouch, Ph. D., Sterling Drug,
Inc., from William V. Purvis, Division of Drug Advertising, Bureau of
Drugs, FDA....
Memorandum of telephone conversation dated December 1, 1975, between
James H. Luther, Sterling Drug, Inc., and Bernard T. Loftus, Division of
Drug Manufacturing, Bureau of Drugs, FDA..
Letter dated December 3, 1975, to E. R. Squibb & Sons, from Alexander M.
Schmidt, M.D., Commissioner, Food and Drug Administration___.
Letter dated December 3, 1975, to Jerome Rotstein, M.D., from
Alexander M. Schmidt, M.D., Commissioner, Food and Drug Adminis-
tration____
Memorandum dated December 8, 1975, to Director, Domestic Investiga-
tions Branch, FDA, from Diana J. Kolaitis, Investigator, FDA.
Memorandum of telephone conversation dated December 10, 1975, be-
tween James Luther, Sterling Drug Co., and T. E. Byers, Associate Di-
rector for Compliance, FDA.
Memorandum of telephone conversation dated February 5, 1976, between
James Luther, Sterling Drug Co., and Bernard T. Loftus, Division of
Drug Manufacturing, Bureau of Drugs, FDA..
Memorandum of telephone conversation dated February 19, 1976, between
James Luther, Sterling Drug Co., and Bernard T. Loftus, Division of
Drug Manufacturing, Bureau of Drugs, FDA...
Memorandum of telephone conversation dated February 20, 1976, between
Edward Seibert, Compliance Officer, FDA, and Bernard T. Loftus,
Division of Drug Manufacturing, Bureau of Drugs, FDA.
Memorandum of telephone conversation dated February 20, 1976, between
James Luther, Sterling Drug Co., and Bernard T. Loftus, Division of
Drug Manufacturing, Bureau of Drugs, FDA.
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