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Appendix B

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§ Gf M Ameiucan Medical Association

535 NORTH DEARBORN STREET • CHICAGO. ILLIMOIS 60610 • PHONE (312) 751-6000 • TWX 910-221 0300

JAMMONS. M 0. tiecul'** Rreiidont (751 6200) September 3, 1981

Arthur Hull Hayes, Jr., M.D. Commissioner of Foods and Drugs 5600 Fishers Lane Rockville, Maryland 20857

RE: ■ Policy on Combination Prescription Drugs r* r r C-. oon irn

Dear Commissioner Hayes:

As v/e communicated to Secretary Schweiker in our letter of June 23, 1981, attached, the Amierican Medical Association is on record as agreeing that controlled clinical studies represent the best method of assessing drug efficacy and safety. We also believe, hoivever, that the accumulated experience of practitioners should be taken into account in determining the efficacy of drugs that have a long record (Df successful use in medical practice. This policy position is particularly applicable to combination prescription drugs where controlled studies may often be difficult, very coscly, and time-consuming to perform and evaluate. We recognize the difficulties faced by FDA in making final decisions about the continued marketability of the hundreds of combination drugs in the Drug Efficacy Study Implementation (DESI). In our view, it is n(3t always necessary for-FDA to insist on the conduct ot controlled clinical studies to provide "adequate evidence of effectiveness for such products. Instead, we believe FDA should evaluate all appropriate indices of efficacy -- including pnysician experience. To this end, "^he Am.erican Medical Association has prepared the attached suggested "Policy on Combination Prescription Drugs" which 'we urge the Agency to incorporate in its implementation of tlie existing regulation at 21 C.F.R. Sec. 300.50. As we conclude in this document.

000019 Dr. Hayes September 3, 1981 Page 2

which will be included in our comprehensive submission to your Task Force on Regulatory Reli.ef, "such a policy would likely be more cost-effective than the current policy, yet would not sacrifice any increment of public safety." ■Your prompt consideration of this request for a modification of existing policy standards v/ill be appreciated,

Sincerely,

James H.'Gammons, n,D,

JHSrww Enclosures POLICY ON COMBINATION PRESCRIPTION DRUGS

Citation

21 C.F.R. Sec. 300.50.

Description

The regulations in effect state, in part, that

(a) Two or more drugs nay be combined in a single dosage form when each, component makes a contribution to the claimed dosage of each component (amount, frequency, duration) is such that the combination is safe and effective for a significant patient popu lation requiring such concurrent therapy as .defined in the labeling for the drug.

AMA Concerns

As a result of 1962 amendments to the Federal Food, Drug, and Cosmetic Act, FDA has been conducting efficacy evaluations of pre-1962 drugs, including combination prescription drugs, in the Drug Efficacy Study Implementation (DESI) program. FDA has 'interpreted and applied Sec. 300.50 to require that data from "well-controlled" clinical ives- tigations be produced to demonstrate efficacy when the accumulated medical literature to date does not contain such data, Such testing of long-used combination' drugs is highly complex scientifically and very costly.

If a manufacturer does not undertake such studies and provide such data to FDA, FDA has been acting to withdraw the combination product's New Drug Application and remove the drug from the market.

Impact

Nothing in FDA's regulations at il C.F.R. Sec. 300.50 requires the clinical study protocols that are very costly, as well as difficult to design and evaluate, that FDA has recjiuested in the DESI review of these combination drugs in recent months. It is within FDA discretion to evaluate each DESI combination prescription drug individually based on all appropriate indices of efficacy.

0^ ■ • ■' ■ ■ ■ , . , . . . NORTH AMERICAN CLINICAL DERMATOLOGIC SOCIETY ' ' EXECUTIVE OFFICES—510 COMMONWEALTH AVE., BOSTON, MASS. 02215 '.L (r /'/v.

PROGRAM DIRECTOR AND VICE PRESIDENT PRESIDENT VICE PRESIDENT ROBERT J. McNAMARA, M.D. JOHN T. McCarthy, m.d. CHARLES I. BLACK. M.D. 2028 TELEGRAPH AVE. 115 E filsl SrnEET 5220 FLANDERS DR. BERKELEY. CA 94705 NEW YORK. N V. 10021 BATON ROUGE, LA 70809

SECRETARY GENERAL COriRESPOtll5INr. SECRETARY TREASURER ■ EDMUND F. FINNERTY. M.D. DAVID W. POLAN. JR.. M.D. ROBERT D. HUBBARD. M.D. 510 COMMONWEALTH AVE. 520 COMMONWEALTH AVE. " 420 COURT STREET BOSTON. MASS. 02215 nOSTQN. MASS 02215 UTICA. N.Y. 13502

May 12, 1982

Marion B. Sulzberger, M.D.

Committee on Use of Topical Medications 1567 Maple Ave. Evansto'n, 111. 60201

Dear Doctor Sulzberger: We are writing to clearly state the opinion of our one hundred sixty-five members, all of whom are active practicing dermatologists, that the proposed removal of combination topical agents would be a medical disaster for two reason,s: 1) The undoubted efficacy of combination products would O lead dermatologists to continue prescribing them - the Patient bearing the cost of compounding. 2) Compounding would be uneven at best. It is the unusual pharmacist who has had any significant experience in accurate compounding. Again, the patient suffers.

We would respectfully refer you to the Editorial "Ban the Balm" Cutis 27:446, May 1981 and the forthcoming June Editorial in the same journal. Curiously, the absence of combination products would increase dermatologists referrals and thus there is no selfish motive involved in condemning^this ill advised Federal action.

Respectfully submi-^ed, ¥ J/n- // ^ ( ^phn T. McCarthy, M.D. President

Edmund T. Finnerty, M.D.' / -.'iVl Secretary Gene.ral

JTM;EPF;j y-,nc.

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June 1, 1982 Jurs 3,

' John T. McCarthy, ?^,D. President American Clinical Dermatologic Sociptv 115 E. 6lst Street " ^ .New York, NY 10021 • ■ EdEStnd P. Pinnerty, r./I,D, Secretary General North American Clinical Dermatologic Society 510 Commonwealth Avenue ^ Boston, Mass, 02215 i Dear Drs, McCarthy and Finnertyj Your letter of May 12, I982 v/aa forwarded to me -from the office of the American Academy of Dermatology and reached me last Friday. As chairman of the ad hoc committee, preparing a statement to the FDA on the proposed removal of ..topical anti-infective agents by the PDA, I wish ito express to you the great encouragement that

• • - your letter has given us. .. " opportunity arises, please convev my thanks ^d the thanks of my committee to the members of the North American Clinical Dermatologic Society. I do not know whether we will he atle to succeed in having the FDA reverse its decision about the removal of topical anti-infectivGS and combinations of such topical agents* However, if we, as physicians v/ho in the best jjosition to observe the effects of the medications we prescribe, do not express our convictions when government agencies propose to ban medicaments v;e have found useful, our patients v/ill vQ those v/hb suffer the most.

• ■ '.1

. • "*■ ' •• ' V'" - , -

' - 2 -

The opinions of your 165 members who are active practitlonGrs of dermatology will constitute Strong support for our position. There is a meeting of representatives of our ad hoc committee tomorrow, and I shall read your letter to them. Thank you again for writing as you did.

Sincerely yours,

^^srion E. Sulzberger, iVi.D,

CO. Peyton E. Weary, M.D.

QQQ02* COMBINATION DRUG QUESTIONNAIRE American Academy of Dermatology, 1567 Maple, Evanston, IL 60201

NOTE TO RESPONDENTS: For purposes of this survey the following definitions will apply:

growth or,^ oro"t ®to kill other micro-organisms.by a micro-organism which has the capacity to inhibit the COMBINATION - a formulation containing more than one active ingredient. Usually a in combination with an anti-infective which is inhibiting to baclerii, fungi, or yeast.

FOR QUESTIONS 1-8 PLEASE CHECK THE APPROPRIATE LINE FOR YOUR RESPONSE TO EACH ITEM.

1. Do you prescribe topical antibiotic combination drugs?

Yes (1) No (2) 2. If "yes,"-how frequently do you prescribe them? Daily (1) Frequently (2) Occasionally (3) ; Rarely (4) 3. Do you prescribe steroid-antibiotic combinations?

Yes (1) No (2) 4. If "yes," how often do you prescribe them? Daily (1) Frequently (2) Occasionally (3) Rarely (4) 5. Do you prescribe topical steroid-antifungal combination drugs?

Yes (1) No (2) If "y®s," how often do you prescribe them? Daily (1) Frequently (2) Occasionally (3) Rarely (4) 7. Do you prescribe topical steroid-antiyeast combinations?

Yes Cl) No (2) 8. If "yes," how often do you prescribe them? Daily (1) Frequently (2) Occasionally (3) Rarely (4)

JUNE^ this QUESTIONNAIRE TO THE ACADEMY OFFICE NOT LATER THAN

(cont'd) 000026 Page 2 PLEASE INDICATE FOR EACH OF THE FOLLOWING CONDITIONS, WHICH TOPICAL ANTIBIOTIC OR STEROID- ANTI-INFECTIVE AGENTS THAT YOU PRESCRIBE. CHECK EACH TREATMENT THAT APPLIES.

(1) ■ (2) (3) (4) I Topical Steroid Steroid Steroid Antibiotics Antibiotic Antiyeast Antifungal Combination Combination Combination Combination 9. Atopic Dermatitis (9-12)

10. Secondarily Infected Eczema (13-16)

11. Secondarily Infected Dermatosis (17-20)

12. Intertrigo (21-24)

13. Impetigo (25-28)

14. Folliculitis (29-32)

15. Sycosis Barbae (33-36)

16. Paronychia (37-40)

17. Pustular Eruption of Hands and Feet (41-44)

18. Hailey-Hailey Disease (45-48)

19. Perleche (49-52)

20. Diaper Rash (49-52)

21. Moniliasis (57-60)

22. Tinea Facei (61-64)

23. Tinea Cruris (65-68)

24. Tinea Capitis (69-72)

25. Tinea Corporis (73-76)

26. Tinea Pedis (77-80)

27. Contact Dermatitis (81-84)

28. Otitis Externa (85-88)

29. Acne (89-92)

30. Rosacea (93-96)

N 31. Tinea Versicolor (97-100)

00Q02? (cont'd) Page 3

OTHER (PLEASE SPECIFY)

PLEASE INDICATE HOW OFTEN YOU HAVE PRESCRIBED THE FOLLOWING COMBINATION DRUGS IN THE LAST YEAR. CHECK ONLY ONE FOR EACH ITEM.

1 . 2 3 4 Frequently Occasionally Rarely Never

32. Bacitracin-Neoraycin (101)

33. Cor-Tar-quin® (102)

34. Cortisporin® (103)

35. Mycolog® (104)

36. Neo-Cordran® (105)

37. Neosporin® (106)

38. Neo-Synalar® (107) O:([ )39. Polysporin® (108)

40. Vioforra-HC® (109)

41. Vytone® (110)

OTHER(S) (PLEASE SPECIFY)

42. If topical antibiotic combinations and topical anti-infection agents combined with were no longer available, and you could no longer prescribe them, how much would this hamper your ability to manage patients? (Ill) > Greatly (1) Mojlerately (2) Slightly (3) Not at all (4)

43. If currently available combination products are removed, with what frequency would you prescribe formulations requiring compounding by pharmacists? (112)

Often (1) Occasionally (2) Rarely.(3)

44. Do you feel that the addition of a to an antibiotic agent is effective in relieving the signs and symptoms of inflammation which result from superficial bacterial yeast and fungal infections. (113) Yes (1) No (2) Possibly (3)

45. Do you feel that the addition of a corticosteroid to an antifungal agent is effective in relieving the signs and symptoms of inflammation which result from superficial bacterial yeast and fungal infections. (114) 00QQ28 Page 4 Yes (1) ^ No (2) Possibly (3) 46. Do you feel that the addition of a . corticosteroid to an antiyeast agent is effective in relieving the signs and symptoms of inflammation which result from superficial bacterial yeast and fungal infections. (115)

No (2) Possibly (3) 47. Please identify your practice type, the activity in which you spend at least 50% of your professional time. (116) Private Practice (1) University and /or Other (3) hospital teaching (2)

QUESTIONNAIRE TO THE ACADEMY OFFICE NOT LATER THAN JUNE 4, 1982

■j: 112 anti-inf6ctives that may qualify for DESI exemptions

Abbott Laboratories Byk-Gulden Erythrocin Ointment Neomycin sulfate- ointment-0.5%, 1%, 2.5% Ambix Laboratories (Div. of Organic Corp. of America) Nystatin-neomycin sulfate-gramicidin- acetonide Neomycin sulfate- ointment • cream American Pbarmaceuticai Co. Bacitracin-neomycin sulfate-polymyxin B sulfate-hydrocortisone Neomycin sulfate-hydrocortisone acetate ointment acetate ointment Biocraft Iodochlorhydroxyquin with Hydrocortisone Cream Neomycin sulfate-hydrocortisone acetate ointment-0.5%, 1%, Ciba Pharmaceutical Co. 2.5% Vioform-Hydrocortisone Cream and Ointment containing io Bacitracin-neomycin sulfate-polymixin B sulfate hydrocortisone dochlorhydroxyquin and hydrocortisone acetate ointment • Clay-Park Laboratories Bryant Neomycin sulfate-hydrocortisone ointment Cortomycin Ointments (1% and 2.5%) Tri-statin Topical Cream - ' Burroughs Wellcome & Co. Nystatin-neomycin sulfate-gramicidin- Neosporin Topical Powder ointment , Neosporin Aerosol Dermik Laboratories, Inc. Neosporin Lotion Neo-Hytone Cream Neosporin-G Cream Ze-Tar-Quin Cream containing diiodohydroxyquin, coal tar, and Cortisporin Cream hydrocortisone Cortisporin Ointment Zetone Cream containing coal tar and hydrocortisone . Vytone Cream containing diiodohydroxyquin with hydrocorti- Neo-Hydeltrasol Ointment Pennwalt Prescription Prods. Doak Pharmacal Co., Inc. Caldecort Ointment Neomycin sulfate-hydrocortisone ointment Caldecort Ointment containing calcium undecylenate 3% and Dome Laboratories hydrocortisone acetate 1% Neo-Cort-Dome Lotion (0.5% and 1%) Pflzer Laboratories Neo-Nysta-Cort Ointment Neo-Magnacort Ointment Neo-Domeform-HC Creme Terra-Cortril Topical Ointment Nysta-Cort Lotion Tena-Cortril Topical Aerosol Nystaform-HC Lotion Premo Pharmaceutical Labs., Inc. Cor-Tar-Quin Cream containing coal tar solution, diiodohy Neomycin sulfate-hydrocortisone ointment droxyquin, and hydrocortisone Myco Triacet Cor-Tar-Quin Lotion containing coal tar solution, diiodohy Nystatin-neomycin sulfate-gramicidin-triamcinolone acetonide

droxyquin, and hydrocortisone cream Neo-Cort-Dome Creme (0.5% and 1%) Reed & Carnrick Dow Pharmaceuticals Neo-Tarcortin Ointment i Neo-Polycin HC Ointment Scheieffelin & Co. ' Bacitracin-neomycin sulfate-polymixin B sulfate-hydrocortisone Neo-Resulin-F Cream y ifi V-.; acetate ointment Sobering Corporation . Ferndale Labs, Inc. Celestone Cream with Neomycin Neomycin sulfate-hydrocortisone ointment Neo-Diloderm Cream ICN Pharmaceuticals Meti-Derm with Neomycin Aerosol Bacitracin zinc-neomycin sulfate-polymyxin B sulfate-hydrocor Meti-Derm with Neomycin Ointment tisone acetate ointment Schlicksup ■■ '5 ' Bacitracin-neomycin sulfate-polymyxin B sulfate-hydrocortisone Nycin-HC Ointment acetate ointment E. R. Squibb ' ' ■ Kasco-Efco Labs (Div. of Byk-Gulden) Kenalog-S Ointment - Neomycin sulfate-hydrocortisone ointment-1%, 2.5% : Kenalog-S Cream ; - — Lederle Labs. ' ^ Kenalog-S Lotion ^#3 ■ ' Neo-Aristocort Ointment Florinef • Neo-Aristocort Cream Mycolog Ointment Neo-Aristocort Foam Myconef Ointment Lemmon Pharmacal Co. Mycolog Cream Racet Cream containing iodochlorhydroxyquin and hydro Syntex Laboratories, Inc. Neo-Synalar Cream Eli Lilly & Co. The Ulmer Pharmacal Co. (Div. of Physicians and Hospitals , , . Cordran-N Ointment . Supply Co.) ,, Cordran-N Lotion ■ Neomycin sulfate-hydrocortamate hydrochloride ointment . ,• Ilotycin (Dista) - . The Upjohn Co. ■ ; .y.vir-'' ■ i' •'}' Ilotycin No. 90 Ointment .. v Neo-Oxylone Ointment '..vrt-' ■i\; . • Cordran-N Cream ' ' ' ' • >•: Neo-Cortef Ointment Merck Sharp & Dohme 'i; ; Neo Delta-Cortef Ointment NeoDecadron Cream containing neomycin sulfate-dexametha- " : .3 Neo-Medrol Acetate \ . sone sodium phosphate ...y, 'v../'.. .:' •3Neo-Cortef Lotion •; i ■'4 ' NeoDecadron Cream containing neomycin sulfate-sodium dexa- ! Neo Delta-Cortef Lotion 3: ■ " ,3 - '. ■ 'Sf,'/ - : Erythromycin Ointment

v. -Neo-Cortef Creams • V Hydromet ' V i:,. ' ^-i'V 3'' ' • Neo-Hydeltrasol ; Warner-Chilcott Laboratories '■ - Neo-Decaspray Aerosol ' ;; Amphocortrin Cream ' Hydroderm Ointment ,v' , r-.'up '' •'-R-'.-y

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