USE OF ADVISORY COMMITTEES BY THE
FOOD AND DRUG ADMINISTRATION

(PART 2)

HEARINGS

BEFORE A

SUBCOMMITTEE OF THE

COMMITTEE ON

GOVERNMENT OPERATIONS
HOUSE OF REPRESENTATIVES

NINETY-FOURTH CONGRESS

FIRST SESSION

APRIL 23; MAY 9 AND 12, 1975

Printed for the use of the Committee on Government Operations

55-495

U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON: 1975

For sale by the Superintendent of Documents, U.S. Government Printing Office
Washington, D.C. 20402 - Price $3.40

COMMITTEE ON GOVERNMENT OPERATIONS

JACK BROOKS, Texas, Chairman

Statement of Alexander M. Schmidt, M.D., Commissioner of Food and

Drugs, Food and Drug Administration, Department of Health, Edu-

cation, and Welfare; accompanied by J. Richard Crout, M. D., Director,

Bureau of Drugs; Peter B. Hutt, Chief Counsel; Robert C. Wetherell,

Jr., Director, Office of Legislative Services; Robert G. Pinco, Chief,

Division of OTC Evaluation; John Jennings, M.D., Associate Com-

missioner for Medical Devices and Diagnostic Products; Mark Novitch,

M.D., Deputy Associate Commissioner for Medical Affairs; and Gary

L. Yingling, Associate Chief Counsel for Enforcement.......

Letters, statements, etc., submitted for the record by-

Page

1

53

111

2, 54, 111

Fountain, Hon. L. H., a Representative in Congress from the State of

North Carolina, and chairman, Intergovernmental Relations and

Human Resources Subcommittee:

April 8, 1975, letter from Clealand F. Baker, Burroughs Wellcome

Co. to J. Richard Crout, M.D., FDA, replying to March 4, 1975,

letter re marketing of products without premarket FDA

clearance.

91-92

August 8, 1972, letter from Gerald F. Myer, Office of Legislative
Services, FDA, to Dr. Delphis C. Goldberg, subcommittee
professional staff member, re status of litigation on drug Ornex. 85-86

Ayerst Laboratories' Epitrate drug recall letter of February 26,

1971__.

76

20

179-180

Bibliography of papers on granulomas associated with the ap-

plication or inhalation of zirconyl compounds.

December 11, 1972, letter from Franz J. Ingelfinger, M.D., to

Henry E. Simmons, M.D., M.P.H., Director, Bureau of Drugs,

FDA, re panel meeting of December 8 and 9, 1972-

Excerpts from the British Medical Journal-Letter to the

editor, by G. H. Jennings, entitled "Alka-Seltzer and Hae-

matemesis," 16:475, 1963; and article, by G. H. Jennings,

entitled "Causal Influences in Haematemesis and Malaena,'

Gut, 6:1-13, 1965__

227-247

Excerpts from the Federal Register concerning the FDA OTC

Antacid Review Panel: January 5, 1972, request for data and

information on safety and effectiveness; April 5, 1973; and

June 4, 1974-

121-122, 183-185, 214-216, 222-224

Excerpt from the Code of Federal Regulations, title 21, chapter

I, entitled "Part 330-Over-the-Counter (OTC) Human Drugs

Which Are Generally Recognized as Safe and Effective and

Not Misbranded"

FDA Talk Paper of October 10, 1973, Gillette Co. recall letter

on certain Right Guard products.

Federal Register notice of September 7, 1973, entitled "Over-

the-Counter Antiperspirant Drug Products and Over-the-

Counter Topical Antibiotic Drugs'

Information from FDA OTC Antacid Review Panel meetings of:

May 8, 1972, second meeting; September, 7 to 9, 1972, fifth

meeting; December 8 and 9, 1972, sixth meeting; January 9,

1973, telephone conference call; and verbatim transcripts from

December 8 and 9, 1972, meetings.

5-10

17

10-13

122-123,

126-129, 143-144, 146-149, 160-168, 188

Letters, statements, etc., submitted for the record by—Continued

Fountain, Hon. L. H.-Continued

Page

118-119

113-115

Information from FDA OTC Antiperspirant Review Panel

meetings of: July 9 and 10, 1974; August 8 and 9, 1974; October

31 and November 2, 1974; December 16 and 17, 1974; January

30 and 31, 1975; and verbatim transcript of March 24, 1975

(closed session) –
15-16, 19, 21-22, 30, 32-33, 58–65

July 8, 1973, memorandum re Rx status of cyclizine and meclizine
from Peter Barton Hutt to Jean Mansur, FDA Bureau of
Drugs, and letter to Gary L. Yingling, Director, OTC staff,
July 18, 1973, from Office of the Assistant to the Director for
Regulatory Affairs, re status of oral preparations containing
chlorcyclizine, cyclizine, or meclizine__
June 18, 1971, memorandum to Henry E. Simmons, M.D.,
M.P.H. (BD-1), from Marion J. Finkel, M.D., Deputy
Director, Bureau of Drugs, subject: Podophyllum: A potentially
dangerous laxative; with memo record on pharmacology
opinion on hazards and actions of podophyllum; and letter
from Mary A. McEniry to Director, FDA OTC Products
Review Staff, re podophyllum containing drugs---

June 20, 1972, letter to Procter & Gamble from Paul A. Bryan,

M.D., Director, DESI Project Office, Bureau of Drugs, re

abbreviated new drug application for Secret---

March 24, 1975, letter to Dr. E. William Rosenberg, Chairman,

FDA Antiperspirant OTC Drug Review Panel from Robert W.

Van Camp, group vice president, Gillette North America, re

panel's November 1974 and January 1975 classification of

zirconyl aerosols in category II..

March 25, 1975, panel statement to Commissioner Schmidt
recommending withdrawal of all zirconium-containing anti-
perspirant aerosols from interstate commerce..

March 28, 1975, letter, with enclosures, from FDA to Chairman

Fountain, re status of certain drugs on the market without

approved NDA's, and compliance with the Drug Listing Act. 87-89

May 16, 1975, letter from Chairman Fountain to FDA Commis-

sioner Schmidt, and Dr. Schmidt's July 3, 1975, reply re re-

moval of podophyllum from the formulation of Carter's

Little Pills.

54-55

57-58

35

115-118

May 17, 1975, letter from Chief Counsel Peter B. Hutt, FDA, to

Chairman Fountain, re court citations to support FDA position

on panel report---.

175-176

May 21, 1975, letter from Chairman Fountain to Commissioner

Alexander M. Schmidt, FDA, re May 17, 1975, letter from

Chief Counsel Peter B. Hutt, FDA

Memorandum to the Commissioner, FDA, from Mary K. Bruch,
Executive of Bureau of Drugs FDA OTC Antiperspirant Panel,
subject: Eighth meeting of the FDA OTC Antiperspirant
Panel-Information Alert_-_.

176-177

Miles Laboratories submissions received by Gary L. Yingling,

FDA, selected material: December 22, 1972, memorandum on

FDA stationery to members of the FDA OTC Antacid Review

Panel and industry liaison on the final proposed draft_report;

December 22, 1972, draft report annotated by Miles Labora-

tories; December 29, 1972, memorandum, subject: Comments

on the proposed draft report of FDA's Advisory Review

Panel on OTC Antacid Drugs, dated December 22, 1972; and

January 3, 1973, memorandum, subject: Notes for presentation

by the Commissioner to Dr. Ingelfinger_.

November 27, 1974, panel statement on aerosol antiperspirants

containing zirconium..

72-74

191-199

23-29

Submissions from FDA OTC Antacid Review Panel's draft report

annotated by Miles Laboratories (page 43 and revised page 43),

and (pages 45 and 46)-
213-21 4, 220-221