[Federal Register Volume 65, Number 82 (Thursday, April 27, 2000)]
[Notices]
[Pages 24704-24706]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-10456]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1256]


Over-the-Counter Drug Products; Public Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
hearing about the agency's approach to regulating over-the-counter 
(OTC) drug products. The purpose of the hearing is to solicit 
information from, and the views of, interested persons, including 
scientists, professional groups, and consumers. FDA intends to elicit 
comment on general issues regarding the status of OTC drug products, 
including the criteria the agency should consider in rendering 
decisions on OTC availability of drugs, the classes of products, if 
any, that are not currently available OTC that should or should not be 
available OTC, how FDA can be assured that consumers understand the 
issues relating to OTC availability of drug products, how rational 
treatment decisions are affected by coexisting prescription and OTC 
therapies for a given disease, whether the current structure for 
marketing OTC products in the United States is adequate, and FDA's role 
in switching products from prescription to OTC status.

DATES: The public hearing will be held on Wednesday, June 28, and 
Thursday, June 29, 2000, from 8:30 a.m. to 4:30 p.m. Submit written 
notices of participation and comments for consideration at the hearing 
by June 2, 2000. Written comments will be accepted after the hearing 
until August 25, 2000.

ADDRESSES: The public hearing will be held at the Gaithersburg Holiday 
Inn, 2 Montgomery Village Ave., Gaithersburg, MD 20879. Submit written 
notices of participation to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852; email: [email protected]; or through the Internet at 
http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm. Submit comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852; email: [email protected]; or through the 
Internet at http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. Transcripts of the hearing will be available for 
review at the Dockets Management Branch (address above) and on the 
Internet at http://www.fda.gov/ohrms/dockets.

FOR FURTHER INFORMATION CONTACT: Patricia L. DeSantis, Center for Drug 
Evaluation and Research (HFD-2), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5400, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA regulates all prescription and OTC drug products marketed in 
the United States. Section 503(b) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 353(b)) describes the criteria for 
determining whether a drug product is subject to prescription 
classification. Under section 503(b)(1) of the act, a drug requires a 
prescription if:

    (A) because of its toxicity or other potentiality for harmful 
effect, or the method of its use, or the collateral measures 
necessary to its use, [it] is not safe for use except under the 
supervision of a practitioner licensed by law to administer such 
drug; or
    (B) [it] is limited by an approved application under section 505 
[of the act] to use under the professional supervision of a 
practitioner licensed by law to administer such drug.
All drug products not meeting the above criteria may be sold OTC.
    In 1972, FDA initiated rulemaking procedures (the OTC Drug Review) 
to determine which OTC drugs can be generally recognized among 
qualified experts as safe and effective and not misbranded under 
prescribed, recommended, or suggested conditions of use. Through the 
OTC Drug Review, FDA establishes monographs for classes of OTC drug 
products (e.g., antacids, skin protectants) that are found to be 
generally recognized as safe and effective and not misbranded when the 
products contain the ingredients and are labeled according to the 
monograph. OTC drug monographs describe the active ingredients, amount 
of drug, formulation, labeling, and other general requirements for 
drugs to be lawfully sold OTC.
    The regulations for the OTC Drug Review are found in part 330 (21 
CFR part 330) and the monographs are in 21 CFR parts 331 through 358. 
The regulations set forth standards for safety, effectiveness, benefit-
to-risk considerations, and labeling of OTC drug products.
    The standards for safety, effectiveness, and labeling for OTC 
products are described in Sec. 330.10(a)(4). Safety for OTC use means a 
low incidence of adverse reactions or significant side effects under 
adequate directions for use and warnings against unsafe use, as well as 
low potential for harm which may result from abuse under conditions of 
widespread availability. Effectiveness means a reasonable expectation 
that, in a significant proportion of the target population, the 
pharmacological effect of the drug, when used under adequate directions 
for use and warnings against unsafe use, will provide clinically 
significant relief of the type claimed. The benefit-to-risk ratio of a 
drug must be considered in determining both safety and effectiveness.
    The labeling of OTC drug products must be clear and truthful in all 
respects and may not be false or misleading in any particular. The 
labeling must state: (1) The intended uses and results of product use; 
(2) the adequate directions for proper use; and (3) the warnings 
against unsafe use, side effects, and adverse reactions in terms that 
render them likely to be read and understood by the ordinary 
individual, including individuals of low comprehension, under customary 
conditions of purchase and use (Sec. 330.10(a)(4)(v)).
    During the course of the OTC Drug Review, advisory review panels of 
nongovernment experts evaluated the various classes of OTC drug 
products and recommended that a number of drugs be switched from 
prescription to OTC status. FDA acted on these recommendations and 
switched a number of products to OTC status, including antihistamines 
(e.g., diphenhydramine hydrochloride (HCl), doxylamine succinate), 
topical nasal decongestants (e.g., oxymetazoline HCl, xylometazoline 
HCl), topical hydrocortisone, topical antifungals (e.g., haloprogin, 
miconazole nitrate), an anthelmintic (pyrantel pamoate), an oral 
anesthetic (dyclonine HCl), and various fluoride dental rinses.
    FDA has also approved the switch of a number of drugs from 
prescription to OTC status under new drug applications. These include 
an antidiarrheal (loperamide), topical antifungals (e.g., clotrimazole, 
terbinafine HCl), antihistamines (e.g.,

[[Page 24705]]

clemastine fumarate), a pediculicide (permethrin), an ocular 
vasoconstrictor (oxymetazoline HCl), vaginal antifungals (e.g., 
clotrimazole, miconazole nitrate), analgesics (e.g., ketoprofen, 
naproxen sodium), acid reducers (e.g., cimetidine, famotidine), a hair 
growth treatment (minoxidil), and smoking cessation drugs (e.g., 
nicotine polacrilex).
    In allowing these drugs to be sold OTC, the agency considered the 
safety and effectiveness criteria stated above, the benefit-to-risk 
ratio, and whether clear and understandable labeling could be written 
for self-medication without the intervention of a health professional. 
In some cases, manufacturers were required to conduct labeling 
comprehension studies to determine if consumers would understand the 
proposed OTC labeling for the products.
    FDA has received comments in the past suggesting that a number of 
other types of drugs should be considered for OTC status. These types 
of products include diuretics, antihypertensive agents, cholesterol-
lowering drugs, antidiabetic drugs, treatments for osteoporosis, 
topical agents for the treatment of perioral herpetic lesions, drugs 
for problems of the stomach and intestines, asthma treatments, and oral 
contraceptives.
    Drugs found appropriate for OTC sale have an increasingly vital 
role in the U.S. health care system by providing consumers easy access 
to certain drugs that can be used safely for conditions that consumers 
can self-treat without the help of a health care practitioner. 
Consumers have access to more than 100,000 OTC drug products 
encompassing more than 800 active ingredients and covering more than 
100 therapeutic categories or classes.
    In light of the continuously changing health care environment, 
including the growing self-care movement, the agency continues to 
examine its overall philosophy and approach to regulating OTC drug 
products. FDA is soliciting information from, and the views of, 
interested persons, including health professional groups, scientists, 
industry, and consumers, on the agency's regulation of OTC drug 
products.

II. Scope of the Hearing

    The regulation of OTC drug products raises many complex public 
health issues. To promote a more useful discussion at the public 
hearing, FDA has developed a list of questions and issues. This list is 
not intended to be exclusive, and presentations and comments on other 
issues related to the development and regulation of OTC drugs are 
encouraged. Issues that are of specific interest to the agency include 
the following:

A. Criteria

     In the context of the present environment, what criteria 
should FDA consider in rendering decisions on OTC availability of drug 
products?
     What types of drugs are or are not appropriate for OTC 
distribution?
     What types of diseases are or are not suitable for 
treatment with products marketed OTC (e.g., chronic illnesses; diseases 
that require initial diagnosis by a physician; diseases that if left 
untreated, or are inadequately treated, can lead to serious morbidity 
or mortality)?
     How should the risks and benefits to individuals and risks 
and benefits to the public health be assessed and weighed in any 
decision on OTC marketing? For example, how should the agency balance 
the potential benefits of OTC antimicrobial agents with the potential 
risks to society at large of the development of resistant organisms 
associated with increased, and potentially improper, use?

B. Classes of Products

     Are there specific classes of products that are not 
currently marketed OTC that should be available OTC? If so, which ones 
and why? What specific evidence should be required to support such 
approvals?
     Are there specific classes of products that should not be 
available OTC? What specific concerns do these classes raise?
    Examples of specific classes that might be discussed in brief 
include: Diuretics, antihypertensive agents, cholesterol-lowering 
drugs, oral antidiabetic agents, treatments for osteoporosis (including 
its prevention), antimicrobials, and oral contraceptives.

C. Consumer Understanding

     How can FDA be assured of consumer understanding of the 
benefits and risks of specific drug products and the ability of 
consumers to use products safely and effectively were the drug products 
to be marketed OTC? Issues that may be discussed include: (1) Sampling 
criteria for comprehension studies; (2) language barriers; (3) 
appropriate use and interpretation of self-administered diagnostic 
tests; (4) ramifications of misdiagnosis; (5) ability of consumers to 
appreciate, without required intervention by a physician, the need for 
continuous (sometimes life-long) treatment, appropriate followup, and 
need for other treatment; (6) consumer confusion between trade names 
and generic/chemical names; and (7) consumer confusion with brand 
extensions (e.g., when the active ingredients generally associated with 
a brand are not present in some of the brand's extended product line).
     What methodologies can be employed to demonstrate consumer 
understanding?
     How can information on efficacy be adequately conveyed to 
consumers through labeling? For example, how can the label adequately 
convey this efficacy information for: (1) Therapies with marginal 
benefit or (2) therapies with preventive claims that may provide 
benefit to a specific population but the benefit to the individual 
consumer is unclear?
     Can prevention claims encourage ill-advised behavior, and 
if so, how could this potential be minimized? For example, would use of 
a cholesterol-lowering drug allow patients to ignore other needed 
interventions such as smoking cessation, dietary discretion, and 
management of other risk factors?

D. Selection of Treatment

     With regard to the choice of treatment regimens, how can 
rational selection be ensured when there are coexisting prescription 
and OTC therapies for a given disease?
     In an environment with coexisting products, what are the 
most effective means to ensure that patients know the best ways to 
treat their illnesses?
     How should the availability of OTC options and 
prescription options for the same indication be reconciled? Are there 
examples where this dichotomy would raise public health concerns?
     Within a therapeutic class, should the first drug to enter 
the OTC market be the ``best'' drug, in terms of the benefit-to-risk 
ratio? How should the availability of a ``better'' OTC product, in 
terms of efficacy or safety, affect the status of products already on 
the OTC market for treatment of the same condition? Should older 
therapies that may provide less benefit or more risk be removed from 
the OTC market, or should the labeling be revised? Suppose the more 
effective drug is more difficult to use and must remain prescription--
might that encourage use of the less satisfactory drug?

E. OTC Marketing System

     Is the current structure for marketing OTC products in the 
United States adequate? What lessons can we learn from different OTC 
marketing systems? For example, what can be learned from the countries 
and those U.S. states where some nonprescription drug products are sold 
OTC and others are sold ``behind the counter''?

[[Page 24706]]

F. FDA's Role in Switches

     Under what circumstances should FDA actively propose OTC 
marketing for a drug in the absence of support from the drug sponsor?
     Should FDA be more active in initiating switches of 
prescription products to OTC use?

III. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs (the Commissioner) is announcing 
that the public hearing will be held in accordance with part 15 (21 CFR 
part 15). The presiding officer will be the Commissioner or her 
designee. The presiding officer will be accompanied by a panel of 
Public Health Service employees with relevant expertise.
    Persons who wish to participate in the part 15 hearing must file a 
written notice of participation with the Dockets Management Branch 
(address above) prior to June 2, 2000. To ensure timely handling, any 
outer envelope should be clearly marked with the Docket No. 00N-1256 
and the statement ``FDA Regulation of OTC Drug Products Hearing.'' 
Groups should submit two copies. The notice of participation should 
contain the person's name; address; telephone number; affiliation, if 
any; the sponsor of the presentation (e.g., the organization paying 
travel expenses or fees), if any; brief summary of the presentation; 
and approximate amount of time requested for the presentation. The 
agency requests that interested persons and groups having similar 
interests consolidate their comments and present them through a single 
representative. FDA will allocate the time available for the hearing 
among the persons who file notices of participation as described above. 
If time permits, FDA may allow interested persons attending the hearing 
who did not submit a written notice of participation in advance to make 
an oral presentation at the conclusion of the hearing.
    After reviewing the notices of participation and accompanying 
information, FDA will schedule each appearance and notify each 
participant by telephone of the time allotted to the person and the 
approximate time the person's oral presentation is scheduled to begin. 
The hearing schedule will be available at the hearing. After the 
hearing, the hearing schedule will be placed on file in the Dockets 
Management Branch under Docket No. 00N-1256.
    Under Sec. 15.30(f), the hearing is informal, and the rules of 
evidence do not apply. No participant may interrupt the presentation of 
another participant. Only the presiding officer and panel members may 
question any person during or at the conclusion of each presentation.
    Public hearings under part 15 are subject to FDA's policy and 
procedures for electronic media coverage of FDA's public administrative 
proceedings (part 10, subpart C (21 CFR part 10, subpart C)). Under 
Sec. 10.205, representatives of the electronic media may be permitted, 
subject to certain limitations, to videotape, film, or otherwise record 
FDA's public administrative proceedings, including presentations by 
participants. The hearing will be transcribed as stipulated in 
Sec. 15.30(b). The transcript of the hearing will be available on the 
Internet at http://www.fda.gov/ohrms/dockets and orders for copies of 
the transcript can be placed at the meeting or through the Freedom of 
Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857.
    Any handicapped persons requiring special accommodations to attend 
the hearing should direct those needs to the contact person listed 
above.
    To the extent that the conditions for the hearing, as described in 
this notice, conflict with any provisions set out in part 15, this 
notice acts as a waiver of those provisions as specified in 
Sec. 15.30(h).

IV. Request for Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written notices of participation and comments for 
consideration at the hearing by June 2, 2000. To permit time for all 
interested persons to submit data, information, or views on this 
subject, the administrative record of the hearing will remain open 
following the hearing until August 25, 2000. Persons who wish to 
provide additional materials for consideration should file these 
materials with the Dockets Management Branch (address above) by August 
25, 2000. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: April 17, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-10456 Filed 4-26-00; 8:45 am]
BILLING CODE 4160-01-F