24704 Federal Register / Vol. 65, No. 82 / Thursday, April 27, 2000 / Notices

Dated: April 21, 2000.

John L. Williams,

Director, Procurement and Grants Office

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–10487 Filed 4–26–00; 8:45 am]

BILLING CODE 4163–18–M

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.

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: FDADockets@oc.fda.gov; 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: FDADockets@oc.fda.gov; 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: desantis@cder.fda.gov.

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 § 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 (§ 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.,

Federal Register / Vol. 65, No. 82 / Thursday, April 27, 2000 / Notices 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 lifelong) 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 cholesterollowering 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’’?

24706 Federal Register / Vol. 65, No. 82 / Thursday, April 27, 2000 / Notices

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 § 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 § 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 § 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

§ 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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Vaccines and Related Biological

Products Advisory Committee; Notice

of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Vaccines and

Related Biological Products Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on May 11, 2000, 8 a.m. to 5:30

p.m. and on May 12, 2000, 8 a.m. to 3

p.m.

Location: Holiday Inn, Kennedy

Grand Ballroom, 8777 Georgia Ave.,

Silver Spring, MD.

Contact Person: Nancy T. Cherry or

Denise H. Royster, Center for Biologics

Evaluation and Research (HFM–71),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12391. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On May 11, 2000, the

committee will hear updates on

activities in the Office of Vaccines

Research and Review. The committee

will also be informed of issues

pertaining to the status of vaccines for

the prevention of rotavirus disease. On

May 12, 2000, the committee will

review issues relating to the

development of policy regarding the use

of various types of neoplastic cells as

substrates for vaccine manufacture.

Procedure: On May 11, 2000, from

9:15 a.m. to 1:45 p.m., and on May 12,

2000, from 9:15 a.m. to 3 p.m., the

meeting is open to the public. Interested

persons may present data, information,

or views, orally or in writing, on issues

pending before the committee. Written

submissions may be made to the contact

person by May 4, 2000. Oral

presentations from the public will be

scheduled between approximately 12:20

p.m. to 12:50 p.m. on May 11, 2000, and

between approximately 10:35 a.m. to

10:50 a.m. and between approximately