Competitive problems in the drug industry

Margreiter, Douglas T., chief of pharmacy section, Colorado Depart-
ment of Social Services, accompanied by Donald Peebles, member,
Colorado Medical Advisory Board.

McKenzie, Hon. Vernon, Principal Deputy Assistant Secretary of

Defense, Health and Environment, accompanied by Rear Adm. C.

Bruce Smith, Supply Corps. U.S. Navy, Commander, Defense Per-

sonnel Support Center; Brig. Gen. Benjamin Baker, Medical Corps,

U.S. Air Force and former chairman, Defense Medical Materiel

Board; and Lt. Col. Theodore D. Wood, Medical Service Corps,

U.S. Army-

Michelotti, Carlo P., assistant chief, Medi-Cal Benefits Section, Cali-
fornia Department of Health...

Pittman, James A., Jr., M.D., executive dean, University of Alabama

School of Medicine, Member, Drug Research Board, National

Academy of Sciences..

Schmidt, Hon. Alexander, M., M.D., commissioner, Food and Drug
Administration, accompanied by J. Richard Crout, M.D., director,
Bureau of Drugs; Thomas W. Brown, director, Compliance Coordi-
nation and Policy Staff, Office of Associate Commissioner for Com-
pliance; Peter Barton Hutt, Chief Counsel; Robert C. Wetherell,
director, Office of Legislative Services; Bernard T. Loftus, Bureau of
Drugs; and Francis J. Flaherty, Office of Associate Commissioner
for Compliance..

Stetler, C. Joseph, president, Pharmaceutical Manufacturers Associa-

tion, accompanied by Bruce J. Brennan, vice president and general

counsel; and Howard L. Binkley, vice president for Research and

Planning

Trygstad, Vernon, president, National Pharmaceutical Council, Inc.,
Washington, D.C., accompanied by Stanley L. Temko, Covington
& Burling, National Pharmaceutical Council Counsel..

(III)

Testimony of-Continued

Weinberger, Hon. Caspar W., Secretary of Health, Education, and

Welfare, accompanied by Stephen Kurzman, Assistant Secretary

for Legislation; Theodore Cooper, M.D., Acting Assistant Secretary

for Health; Alexander M. Schmidt, Commissioner, Food and Drug

Administration; Dr. Keith Weikel, Commissioner, Medical Services

Administration, Social and Rehabilitation Service; Dr. Mark No-

vitch, Deputy Associate Commissioner for Medical Affairs, Food and

Drug Administration; Dr. J. Richard Crout, Director, Bureau of

Drugs, Food and Drug Administration; and Vincent R. Gardner,

Chief, Drug Studies Branch, Office of Research and Statistics, Social

Security Administration..

Witt, Hugh E., Administrator for Federal Procurement Policy, Office

of Management and Budget, accompanied by Louis Sorett, Manage-

ment analyst, General Services Administration....

Zechman, Ronald E., Associate Administrator, Office of Federal

Management Policy, General Services Administration___

EXHIBITS

Claim Forms Nos. 3554110-3554113 used by the State of Colorado Depart-
ment of Social Services...

11707

Letter dated May 7, 1975, to Benjamin Gordon, staff economist, Select

Committee on Small Business, U.S. Senate, from John T. Manning,

assistant general counsel, Veterans Administration..

Interagency Agreement between the Defense Supply Agency and the Food

and Drug Administration, formally signed on Oct. 22, 1974.

Letter dated May 24, 1974, to Director, Defense Supply Agency, from

Vernon McKenzie, Assistant Secretary of Defense, Health and Environ-

ment...

11756

11770

List of the Department of Defense personnel engaged in drug quality as-

Material supplied by the Nelson Subcommittee for inclusion in the hearing

record:

Letter dated February 13, 1975, to Hearing Clerk, Food and Drug

Administration, from Earl J. Kolb, Jr., M.D., Central Medical

Clinic-

Abbott comments on Upjohn studies..

Letter dated March 3, 1975, to Hon. Alexander M. Schmidt, M.D., Com-

missioner, Food and Drug Administration, from Senator Gaylord

Nelson, Chairman, Select Committee on Small Business, U.S. Senate,

with accompanying reply..-

Letter dated Feb. 24, 1975, to Hearing Clerk, Food and Drug Ad-

ministration, from Charles A. Tobin, Secretary, Federal Trade Com-

mission, with accompanying statement

Letter dated June 2, 1975, to Hon. Caspar W. Weinberger, Secretary,

Department of Health, Education, and Welfare, from Senator

Gaylord Nelson, Chairman, Select Committee on Small Business,

U.S. Senate, with accompanying enclosures

Letter dated June 19, 1975, to Senator Gaylord Nelson, chairman,

Select Committee on Small Business, U.S. Senate, from Hon.

Caspar W. Weinberger, Secretary, Department of Health, Educa-

tion, and Welfare___

Letter dated Jan. 10, 1975, to William L. Davis, president, Ayerst

Laboratories, from William F. Appel, R.Ph., Appel Pharmacy--

"Recently, the future of your health was debated. You won," adver-

tisement from U.S. News and World Report, Oct. 21, 1974.

Letter dated Mar. 11, 1975, to Senator Gaylord Nelson, Chairman,

Select Committee on Small Business, U.S. Senate, from Edward G.

Feldmann, Ph.D., Associate Executive Director for Scientific

Affairs, American Pharmaceutical Association___

"Brand vs Generic Drugs: It's Only a Matter of Name," by Henry
E. Simmons, M.D., M.P.H., Director, Bureau of Drugs, Food and
Drug Administration, article reprinted from FDA Consumer, March

1973.

11841

Appendix-Material supply by Nelson subcommitte-Continued
Letter dated Feb. 12, 1975, to Senator Gaylord Nelson, chairman,
Select Committee on Small Business, U.S. Senate, from Dr. Philip
Handler, President, National Academy of Sciences, with accom-
panying press release..

Letter dated March 18, 1975, to Senator Gaylord Nelson. Chairman,
Select Committee on Small Business, U.S. Senate, from James L.
Henry, M.D., President, Ohio State Medical Association, with ac-
companying enclosure.

Letter dated March 25, 1975, to Senator Gaylord Nelson, Chairman,
Select Committee on Small Business, U.S. Senate, from James H.
Sammons, M.D.. Executive Vice President, American Medical As-
sociation

Prepared statements:

Page

11845

11850

11857

Ahart, Gregory J., director, Manpower and Welfare Division, General
Accounting Office..

Berliner, Robert W., M.D., dean, Yale School of Medicine, and Chairman, Drug Bioequivalence Study Panel

11862

11876

Lee, Lyndon E., Jr., M.D., assistant chief medical director for Professional Services, Department of Medicine and Surgery, Veterans Administration..

11881

McKenzie, Hon. Vernon, Principal Deputy Assistant Secretary of
Defense, Health and Environment...

11898

Schmidt, Hon. Alexander M., M.D., Commissioner, Food and Drug
Administration_-

11908

Trygstad, Vernon, president, National Pharmaceutical Council, Inc.,
Washington, D.C.

11924

Exhibits provided by the U.S. Department of Health, Education, and
Welfare:

Prepared statement of Hon. Caspar W. Weinberger, Secretary-
List of drug recalls conducted by the Food and Drug Administration
in fiscal years 1974-75..

11936

11965

Exhibits provided by the American Pharmaceutical Association:

Prepared statement of Dr. William S. Apple, Executive Director.. 11995
Comments of the American Pharmaceutical Association on proposed
rulemakings: 39 F.R. 40302, 39 F.R. 41480, 40 F.R. 3218, and 40
F.R. 3219

12007

"MD attacks arguments against MAC program," article from American Medical News, Mar. 3, 1975...

12013

Exhibits provided by the California Department of Health:

Prepared statement of Carlo P. Michelotti, assistant chief, Medi-Cal
Benefits Section_.

12014

Letter dated Jan. 8, 1975, to hearing clerk, Food and Drug Administration, from William Mayer, M.D., Director of Health, Department of Health, State of California.

Letter dated Mar. 10, 1975, to Mark Novitch, M.D., Deputy Associate
Commissioner for Medical Affairs, Food and Drug Administration,
from Mario G. Obledo, Secretary, Health and Welfare Agency,
State of California..

12022

12046

Exhibits provided by the Colorado Department of Social Services:
Prepared statement of Peter Samac, Deputy Director_-
Medical Advisory Council composition as dictated by Colorado

12070

statute..

12084

Exhibits provided by the Office of Management and Budget and General
Services Administration:

Prepared statement of Hugh E. Witt, Administrator for Federal Procurement Policy, OMB...

12085

Prepared statement of Ronald E. Zechman, Associate Administrator,
Office of Federal Procurement Policy, GSA...

Attachment A: Study of An Optimum Procurement and Distribution
System(s) for Medical and Nonperishable Subsistence Items.
Attachment B: OMB Memorandum Dated June 4, 1974, Subject:
Procurement and Distribution of Medical and Nonperishable
Subsistence Supplies, and attachment. -

12089

12098

12178

Attachment C: The Interagency Medical and Nonperishable Subsistence Supply Management Charter, Approved September 1974. 12182

Exhibits-Continued

Attachment D: Task Order No. 1, Approved Sept. 27, 1974, Sub-

ject: Establishment of a Task Group to Determine Criteria for

Defining Categories of Medical Items.

Attachment E: GSA Order (ADM 5420.46 Dated Feb. 3, 1975),

Subject: Establishment of the Interagency Medical and Non-

perishable Subsistence Supply Management Committee -

Attachment F: Memorandum dated Feb. 20, 1975 to the chairman of