The DESI Hit List--its impact on dermatology

On Sept. 24, 1981, the Food and Drug Admin- istration announced at a special meeting its intent to remove a large number of topical antibiotic and antibiotic-corticosteroid combination drugs from the market for lack of established efficacy under the Drug Efficacy Study Implementation (DESI) review process. At that time, several invited der- matologists, including James Leyden, M.D., and Peyton Weary, M.D., protested this action vigor- ously on behalf of the specialty.

Two weeks later, on October 6, at the Com- missioner's meeting with the Ad Hoc Professional Society representatives, Dr. Weary, who was speaking on behalf of the American Academy of Dermatology, outlined for the Commissioner and fifty other individuals the adverse impact of this decision and presented an issues paper. Commis- sioner Arthur Hull Hayes, Jr., M.D., indicated that the FDA would welcome a report from an inde- pendent committee appointed by the Academy to review the efficacy data in a broader context with more emphasis on alleviation of symptoms, more suitable end points, and with special attention to recent evidence about etiologic mechanisms of ec- zematous dermatoses.

With that assurance in hand, a letter was sent to the FDA requesting a hearing, at which time the report prepared by an ad hoc committee could be presented. In addition, a follow-up letter was sent to the Commissioner on Nov. 13, 1981.

The Ad Hoc Committee has been appointed and held its first meeting in San Francisco on Tuesday during the Academy Annual Meeting. The Com- mittee chairman is Marion Sulzberger, M.D. Other committee members include Dr. Leyden, vice-chairman, William Eaglstein, M.D., Henry Earl Jones, M.D., Howard Maibach, M.D., Larry Millikan, M.D., Richard Odom, M.D., Edgar B. Smith, M.D., David Taplin, M.D., Maxwell Fin-

land, M.D. (consultant), Brian Strom, M.D, (con- sultant), John Epstein, M.D. (ex-officio), John Strauss, M.D. (ex-officio), and Dr. Weary (ex- officio).

Because of time constraints, the Committee must act decisively and with some alacrity to fash- ion a report in the time allotted by the FDA, as indicated in the letter from the Commissioner which was addressed to Dr. Harold O. Perry and is hereby published with his permission:

I am writing at the suggestion of Peyton Weary, M.D., Chairman, Council on Govern- mental Liaison, American Academy of Derma- tology. He had written me about the concerns expressed by many dermatologists that their views would not be heard.

This letter is to assure the Academy and its members that the Food and Drug Administra- tion will be pleased to receive a report that is being prepared by the Academy's study group on certain prescription topical anti-infective drug products that FDA's Bureau of Drugs is proposing to withdraw from the market. Indeed, the FDA's own regulations explicitly permit in- terested persons, such as the Academy's mem- bers, to submit comments to proposals to with- draw approval of drugs.

As you may know, on September 25, 1981, the Director of the FDA's Bureau of Drugs is- sued a notice of opportunity for a hearing on whether the approval should be withdrawn for certain prescription drug products that are single-entity antibiotics or combination anti- infective products for dermatologic use. I em- phasize to Academy members that the Bureau of Drugs' notice does not represent a final agency decision on the effectiveness of those drugs. Rather, the notice is the first step toward final resolution of this question. If I as Com- missioner of Food and Drugs ultimately find that the products lack substantial evidence of

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effectiveness, they must be removed from the market. Before a final decision, however, sev- eral procedural steps will be taken.

A separate letter to Dr. Weary outlines the procedural factors involved in receiving a report from the Academy. Several factors should be mentioned here. First, it is necessary that any report prepared be submitted in time to be use- ful. The Academy's request for a hearing in the proceeding, dated October 19, 1981, indicates that a period of at least six months would be needed to allow the committee to assemble and review the information and prepare a position paper. Under the terms of the court orders en- tered by Judge Bryant, FDA is required to meet certain deadlines in deciding whether drugs are effective. To be useful, any report submitted by the Academy would have to be submitted to the FDA's Bureau of Drugs by August 1, 1982.

More important, the report must recognize the statutory requirement that the effectiveness of new drugs be supported by adequate and well-controlled investigations. Anecdotal in- formation and testimonials cannot be consid- ered in deciding whether a drug is effective. The agency would welcome from the Acad-

emy's study group, or members of the Acad- emy, any evidence that meets the statutory standard and that bears on the effectiveness of the drugs in question. I have requested the Bu- reau of Drugs to consider any report that is submitted by the Academy in deciding whether to grant a hearing on these drugs. If a hearing is granted, the parties at the hearing--the Bureau and the manufacturers who have submitted hearing requests--will be directed to include the Academy's report with other documentary evidence at the hearing. To aid the Academy in preparing its report, I am asking the Dockets Management Branch to send to Dr. Weary copies of the submissions received from the drug manufacturers in support of their hearing requests.

In sum, the September 25 notice is prelimi- nary in nature, procedures exist to resolve the issues raised in the notice, the final decisions on the drugs in question will be made by the Com- missioner of the Food and Drugs, and we would welcome a timely report from the Academy as assistance in reaching a sound decision.

Arthur Hull Hayes, Jr,, M.D. Cornmissiorter of Food and Drugs

112 anti-infectives that may qualify for DESI exemptions

Abbott Laboratories Erythrocin Ointment

Ambix Laboratories (Div. of Organic Corp. of America) Neomycin sulfate-hydrocortisone acetate ointment

American Pharmaceutical Co. Neomycin sulfate-hydroeortisone acetate ointment

Biocrafl Neomycin sulfate-hydroeortisone acetate ointment-0.5%, 1%,

2.5% Bacitracin-neomycin sulfate-polymixin B sulfate hydroeortisone

acetate ointment Bryant

Cortomycin Ointments (1% and 2.5%) Burroughs Wellcome & Co.

Neosporin Topical Powder Neospodn Aerosol Neosporin Lotion Neosporin-G Cream Cortisporin Cream Cortispodn Ointment

Byk-Guiden Neomycin sulfate-hydrocortisone ointment-0.5%, 1%, 2.5% Nystatin-neomycin sulfate-gramicidin-triamcinolone acetonide

c r e a m

Bacitracin-neomycin sulfate-polymyxin B sulfate-hydrocortisone acetate ointment

lodochlorhydroxyquin with Hydrocortisone Cream Ciba Pharmaceutical Co.

Vioform-Hydrocortisone Cream and Ointment containing io- dochlorhydroxyquin and hydrocortisone

Clay-Park Laboratories Neomycin sulfate-hydrocortisone ointment Tri-statin Topical Cream Nystatin-neomycin sulfate-gramicidin-triamcinolone acetonide

ointment Dermik Laboratories, Inc.

Neo-Hytone Cream Ze-Tar-Quin Cream containing diiodohydroxyquin, coat tar, and

hydrocortisone Zetone Cream containing coal tar and hydrocortisone

Volume 6 Number 4, Part 1 April, 1982

Vytone Cream containing diiodohydroxyquin with hydrocorti- sone

Doak Pharmacai Co., Inc. Neomycin sulfatc-hydrocortisone ointment

Dome Laboratories Neo-Cort-Dome Lotion (0.5% and 1%) Neo-Nysta-Cort Ointment Neo-Domeform-HC Creme Nysta-Cort Lotion Nystaform-HC Lotion Cor-Tar-Quin Cream containing coal tar solution, diiodohy-

droxyquin, and hydrocortisone Cor-Tar-Quin Lotion containing coal tar solution, diiodohy-

droxyquin, and hydrocortisone Neo-Cort-Dome Creme (0.5% and 1%)

Dow Pharmaceuticals Neo-Polycin HC Ointment Bacitracin-neomycin sulfate-po[ymixin B sulfate-hydrocortisone

acetate ointment Ferndale Labs, Inc.

Neomycin salfate-hydrocortisone ointment ICN Pharmaceuticals

Bacitracin zinc-neomycin sulfate-polymyxin B sulfate-hydrocor- tisone acetate ointment

Bacitracin-neomycln sulfate-polymyxin B sulfate-hydrocortisone acetate ointment

Kasco-Efco Labs (Div. of Byk-Gulden) Neomycin sulfate-hydrocortisone ointment-1%, 2.5%

Ledcrle Labs. Neo-Aristocort Oimment Neo-Aristocort Cream Neo-Aristocort Foam

Lemmon Pharmacal Co. Racer Cream containing iodochlorhydroxyquin and hydro-

cortisone Eli Lilly & Co.

Cordran-N Ointment Cordran-N Lotion Ilotycin (Dista) llotycin No. 90 Ointment Cordran-N Cream

Merck Sharp & Dohme NeoDecadron Cream containing neomycin sulfate-dexametha-

sone sodium phosphate NeoDecadron Cream containing neomycin sulfate-sodium dexa-

mcthasone Hydromet Neo-Hydeltrasol Neo-Decaspray Aerosol Hydroderm Ointment

D E S I Hi t List 77A

Neo-Hydeltrasol Ointment Pennwalt Prescription Prods.

Caldecort Ointment Caldecort Ointment containing calcium undecylenate 3% and

hydrocortisone acetate 1% Pfizer Laboratories

Neo-Magnacort Ointment Terra-Cortril Topical Ointment Terra-Cortril Topical Aerosol

Premo Pharmaceutical Labs., Inc. Neomycin sulfate-hydrocortisone ointment Myco Triacet Nystatin-neomycin sulfate-gramicidin-triameinolone acetonide

cream Reed & Carnrick

Neo-Tarcortin Ointment Scheieffelin & Co.

Neo-Resulin-F Cream Schering Corporation

Celestone Cream with Neomycin Neo-Diloderm Cream Meti-Derm with Neomycin Aerosol Meti-Derm with Neomycin Ointment

Schlicksup Nycin-HC Ointment

E. R. Squibb Kenalog-S Ointment Kenalog-S Cream Kenalog-S Lotion Ftorinef Mycolog Ointment Myconef Ointment Mycolog Cream

Syntex Laboratories, Inc. Neo-Synalar Cream

The Ulmer Pharmacal Co. (Div. of Physicians and Hospitals Supply Co.) Neomycin sulfate-hydrocortamate hydrochloride ointment

The Upjohn Co. Neo-Oxylone Ointment Neo-Cortef Ointment Neo Delta-Cortef Ointment Neo-Medrol Acetate Neo-Cortef Lotion Neo Delta-Cortef Lotion Erythromyein Ointment Neo-Cortef Creams

Warner-Chilcott Laboratories Amphocortrin Cream