[Federal Register: June 28, 2005 (Volume 70, Number 123)]
[Page 37102-37103]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005D-0240]

Draft Guidance for Industry on Gingivitis: Development and 
Evaluation of Drugs for Treatment or Prevention; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Gingivitis: 
Development and Evaluation of Drugs for Treatment or Prevention.'' The 
draft guidance is intended to assist sponsors in developing clinical 
trials for drug products that treat or prevent gingivitis. It addresses 
specific protocol design elements as well as general concerns about 
drugs for this indication.

DATES: Submit written or electronic comments on the draft guidance by 
August 29, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the draft guidance to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 See the SUPPLEMENTARY INFORMATION section for electronic 

access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Frederick Hyman, Center for Drug 
Evaluation and Research (HFD-540), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2020.


I. Background

    FDA is announcing the availability of a draft guidance for industry 

[[Page 37103]]

``Gingivitis: Development and Evaluation of Drugs for Treatment or 
Prevention.'' This guidance is intended to assist sponsors in 
developing clinical trials for drug products that treat or prevent 
    Gingivitis, an inflammation of the soft tissues that surround the 
teeth, is a part of the wider classification of periodontal diseases, 
which include gingivitis at the milder end and periodontitis at the 
more severe end. In 1986, FDA approved Peridex (0.12% chlorhexidine 
gluconate rinse), the first prescription product for gingivitis. In 
1997, Colgate's Total toothpaste (0.30% triclosan, 0.24% sodium 
fluoride) was approved through the new drug application (NDA) process 
as an over-the-counter (OTC) dentifrice that also has a gingivitis 
indication. During the past several decades, many products have also 
entered the marketplace as OTC products that were purported to treat or 
prevent gingivitis. As a result of the proliferation and promotion of 
those products, the agency convened a subcommittee of the Dental 
Products Panel (the Subcommittee) in 1993 to evaluate OTC products that 
make gingivitis and related claims and that were in the marketplace 
without an NDA. The Subcommittee's charge was to review the submitted 
data and to report its findings on the safety and effectiveness of OTC 
ingredients for the reduction or prevention of gingivitis. On May 29, 
2003, a final subcommittee report was published in the Federal Register 
(68 FR 32232) as an advance notice of proposed rulemaking, the first 
step in establishing an OTC monograph for these drug products.
    Unlike the NDA process that consists of a review of the entire drug 
product, the monograph process reviews only active ingredients in the 
class of drug products for safety and efficacy. Until the monograph is 
finalized, only gingivitis products containing active ingredients that 
were marketed in the United States before 1975 can continue to be 
marketed. Any manufacturer attempting to enter the marketplace with a 
gingivitis product containing an active ingredient that has no prior 
marketing history in the United States should either petition the 
developing monograph to consider its inclusion or submit a new NDA for 
approval before marketing. Sponsors of OTC antigingivitis drugs with 
active ingredients that the Subcommittee classified as needing further 
information to make a decision are encouraged to submit further data 
for review. As a result of these actions, FDA is publishing this 
guidance document on the development of antigingivitis drugs. The 
guidance is intended to aid drug sponsors in developing clinical trials 
either for submitting additional information to the antigingivitis 
rulemaking, or for gaining approval for a new antigingivitis drug 
through the NDA process.
    This guidance document provides assistance in several ways. It 
addresses specific design elements such as choosing inclusionary and 
exclusionary criteria, selecting relevant endpoints, assessing 
gingivitis, determining the clinical significance of the effect, and 
collecting meaningful safety data. It also provides comments on general 
concerns (e.g., prevention versus treatment claims, OTC versus 
prescription status, special population enrollment, and nonclinical 
development issues related to products that are intended for 
administration within the oral cavity for the treatment or prevention 
of gingivitis).
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on the 
development and evaluation of drugs for treatment or prevention of 
gingivitis. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The draft guidance and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
    Dated: June 22, 2005.

Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12764 Filed 6-27-05; 8:45 am]