[Federal Register Volume 62, Number 223 (Wednesday, November 19, 1997)]
[Proposed Rules]
[Pages 61710-61712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30410]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 333, 347, and 348

[Docket Nos. 80N-0476, 78N-0301, 78N-0021, and 75N-0183]
RIN 0910-AA01


Antifungal Drug Products for Over-the-Counter Human Use; External 
Analgesic Drug Products for Over-the-Counter Human Use; Skin Protectant 
Drug Products for Over-the-Counter Human Use; and Topical Antimicrobial 
Drug Products for Over-the-Counter Human Use; Reopening of 
Administrative Records

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of administrative records.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
reopening of the administrative records for four rulemakings to include 
safety and effectiveness data on over-the-counter (OTC) vaginal douche 
drug product ingredients that were previously considered in the advance

[[Page 61711]]

notice of proposed rulemaking for OTC vaginal drug products. The agency 
is reopening the following rulemakings for consideration of data on 
vaginal douche drug products: (1) Antifungal drug products, (2) OTC 
external analgesic drug products (3) OTC skin protectant drug products 
and (4) OTC topical antimicrobial drug products. This action is part of 
the ongoing review of OTC drug products conducted by FDA.

DATES: Submit written comments by February 17, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Helen Cothran, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2222.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 13, 1983 (48 FR 46694), FDA 
published under 21 CFR 330.10(a)(6), an advance notice of proposed 
rulemaking to establish a monograph for OTC vaginal drug products, 
together with the recommendations of the Advisory Review Panel on OTC 
Contraceptives and Other Vaginal Drug Products (the Panel), which was 
the advisory review panel responsible for evaluating data on the active 
ingredients in OTC vaginal drug products. In its report, the Panel 
recommended Category I (i.e., safe and effective) status for 1 to 3 
percent potassium sorbate and 0.15 to 0.3 percent povidone-iodine as a 
douche for the relief of minor vaginal itching, irritation, and 
soreness (48 FR 46694 at 46704 to 46706). The Panel also recommended 
the following ingredients as Category I in a douche formulation to 
remove vaginal discharge and vaginal secretions, for a mild detergent 
action, and to thin out vaginal mucus discharge: 0.002 percent dioctyl 
sodium sulfosuccinate (docusate sodium), 0.0176 percent nonoxynol 9, 
0.088 percent octoxynol 9, and 0.01 to 0.02 percent sodium lauryl 
sulfate (48 FR 46706 to 46707). In the preamble to the Panel's report 
(48 FR 46694 to 46695), the agency did not allow the marketing of 
potassium sorbate for relief of minor vaginal irritation because it was 
considered a new drug (had not been marketed for a material time and 
extent).
    In the Federal Register of February 3, 1994 (59 FR 5226), the 
agency issued a notice to withdraw the advance notice of proposed 
rulemaking of October 13, 1983. This action was taken in part because 
the agency determined that some of the Panel's recommended labeling 
indications related to cosmetic claims and not drug claims. The agency 
also stated that the intended use of a product will be considered in 
determining whether it is a cosmetic, a drug, or both (59 FR 5226 at 
5231). In addition, recommended labeling indications and ingredients 
used for minor irritation, itching, or soreness are not unique to the 
vaginal area and are already being considered in other OTC drug 
rulemakings (e.g., antifungal, antimicrobial, and external analgesic). 
Therefore, the agency stated that those ingredients and claims would be 
considered in those other rulemakings, as appropriate.

II. Recent Developments

    In the Federal Register of March 27, 1997 (62 FR 14683), the agency 
announced that its Nonprescription Drugs Advisory Committee (NDAC) 
would hold a public meeting on April 15, 1997, to discuss a possible 
association between vaginal douching and adverse consequences. The 
notice stated that FDA is aware of a number of case-control 
epidemiologic studies in the literature that suggest a possible 
association between vaginal douching and several conditions, such as 
pelvic inflammatory disease, ectopic pregnancy , and cervical cancer 
(Ref. 1). At the April 15, 1997, meeting, NDAC members were joined by 
representatives from two other FDA advisory committees, Reproductive 
Health Drugs and Anti-infective Drugs, as well as representatives from 
the Center for Food Safety and Applied Nutrition and the Center for 
Devices and Radiological Health. The Committees discussed issues 
relating to behavioral, epidemiological, and microbiological aspects of 
vaginal douching. Committee members felt that there was a suggestive 
association between vaginal douching and ectopic pregnancy and pelvic 
inflammatory disease, but that more data and further research were 
needed to support such an association. Some members stated that a 
possible association between douching and tubal infertility also needed 
more investigation. The Committees did not find any evidence of a 
relationship between vaginal douching and cervical carcinoma. Some 
members expressed concern that certain individuals who douche, e.g., 
those with sexually transmitted diseases or multiple sexual partners, 
may be at increased risk for ectopic pregnancy, tubal disease, or tubal 
infertility. The Committees were also concerned about the risks and 
benefits/efficacy of vaginal douche products. The Committee members 
stressed that labeling for these products should be easy to read and 
understand, and should provide consistent information across the broad 
product class. The Committees encouraged the use of educational 
programs for both consumers and health care providers as a way to 
expand the public's knowledge about use of these products (Ref. 2).

III. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Letter from D. Bowen, FDA, to R.W. Soller, Nonprescription 
Drug Manufacturers Association, coded LET 105, Docket No. 75N-0183, 
Dockets Management Branch.
    2. Comment No. TR1, Docket No. 80N-0476, Dockets Management 
Branch.

IV. Reopening of the Administrative Records

    Because the issues concerning the safety of vaginal douching also 
have an impact on the agency's review of the safety and effectiveness 
of all OTC vaginal douche drug products, the agency is reopening the 
administrative records for the rulemakings for OTC antifungal drug 
products (Docket No. 80N-0476), (2) OTC external analgesic drug 
products (Docket No. 78N-0301), (3) OTC skin protectant drug products 
(Docket No. 78N-0021), and (4) OTC topical antimicrobial drug products 
(Docket No. 75N-0183). This action is to specifically allow for 
submission of data on the issues raised at the April 15, 1997, meeting. 
The agency also requests safety and effectiveness data on the vaginal 
douche drug product ingredients that were discussed at that meeting.
    Interested persons may submit comments on OTC vaginal douche drug 
products to the applicable docket number(s) based on the ingredient's 
labeling claim(s), intended use, or mechanism/mode of action. For 
example, data on povidone-iodine for the relief of minor vaginal 
itching and irritation may be submitted to the external analgesic 
rulemaking, but if relief of itching is due to an antifungal effect, 
i.e., killing the fungus, data should be submitted to the antifungal 
rulemaking . Likewise, if data support the use of nonoxynol 9 for the 
relief of minor vaginal itching and irritation because of an 
antimicrobial action, data should be submitted to the antimicrobial 
rulemaking. Interested

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persons should determine the appropriate rulemaking to which data 
should be submitted. Comments on other vaginal drug products or issues 
should not be submitted at this time.
    Submit written comments on or before February 17, 1998 to the 
Dockets Management Branch (address above). Three copies of any comments 
are to be submitted, except that individuals may submit one copy. If 
comments could be submitted to several dockets, they may be submitted 
to one docket and cross-referenced in the other docket(s). All comments 
are to be identified with the appropriate docket number(s) found in 
brackets in the heading of this document and may be accompanied by a 
supporting memorandum or brief. Received comments may be seen in the 
office above between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 12, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-30410 Filed 11-18-97; 8:45 am]
BILLING CODE 4160-01-F