[Federal Register Volume 77, Number 39 (Tuesday, February 28, 2012)]
[Pages 12059-12062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4597]



Food and Drug Administration

[Docket No. FDA-2012-N-0171]

Using Innovative Technologies and Other Conditions of Safe Use To 
Expand Which Drug Products Can Be Considered Nonprescription; Public 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.


SUMMARY: The U.S. Food and Drug Administration (FDA or the Agency) is 
announcing a public hearing to obtain input on a new paradigm we are 
considering. Under this paradigm, the Agency would approve certain 
drugs that would otherwise require a prescription for nonprescription 
use (also known as over-the-counter or OTC) under conditions of safe 
use. These conditions of safe use would be specific to the drug product 
and might require sale in certain pre-defined health care settings, 
such as a pharmacy. This public hearing is being held to obtain 
information and comments from the public on the feasibility of this 
paradigm and its potential benefits and costs.

DATES: Public Hearing: The public hearing will be held on March 22 and 
23, 2012, from 9 a.m. to 4 p.m. The meeting may be extended or may end 
early depending on the level of public participation.
    Presentations and Comments: Submit either electronic or written 
requests for oral presentations and comments by March 9, 2012. (See 
section IV of this document for details.) Either electronic or written 
comments will be accepted after the hearing until May 7, 2012 (See 
section VI of this document for details.)

ADDRESSES: The public hearing will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31, Rm. 1503, Silver Spring, MD, 20993-
    Comments and Transcripts: Submit either electronic or written 
comments 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://www.regulations.gov. All comments 
should be identified with the docket number found in brackets in the 
heading of this document. Transcripts of the hearing will be available 
for review at the Division of Dockets Management and on the Internet at 
http://www.regulations.gov approximately 45 days after the hearing.

FOR FURTHER INFORMATION CONTACT: Lee Lemley, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20903-0002, 301-796-3441, Fax: 301-847-8753, email: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing a public hearing to obtain 
input on a potential new paradigm under which the Agency would approve 
certain drugs that would otherwise require a prescription for 
nonprescription use under conditions of safe use specific to the drug 
product. Some drugs approved in this manner might require sale in 
certain pre-defined health care settings, such as a pharmacy.

I. Background

A. Prescription and Nonprescription Drugs

    Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA 
approves new drugs under section 505 (21 U.S.C. 355) either as 
prescription or nonprescription. Under section 503(b)(1)(A) of the FD&C 
Act (21 U.S.C. 353(b)(1)(A)), a drug must be dispensed by prescription 
if, ``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.'' Under sections 
505(d)(1) and (d)(4), FDA has considerable latitude in determining 
whether the information submitted as part of a new drug application 
(NDA) is sufficient to ensure that a drug is safe for use under its 
proposed labeling. FDA also makes a determination under 503(b) as to 
whether the product meets the criteria for prescription-only 
    Prescription drugs are dispensed upon receipt of a prescription 
from a practitioner licensed by law to administer the drug (which may 
include health care professionals such as physicians, nurse 
practitioners, physician's assistants, and others whom we will refer to 
here as practitioners or prescribers). (See 21 U.S.C. 353(b).) In many 
instances, under the current regulatory system, a patient has to obtain 
at least the initial prescription, and in some cases, prescription 
refills, from a practitioner through an in person interaction. 
Obtaining a refill for other prescription drugs involves at least a 
telephone call or other communication with the practitioner. In 
contrast, nonprescription drugs (sometimes referred to as over-the-
counter or OTC products) can be purchased by consumers in pharmacies, 
supermarkets, and other retail establishments without the need for a 
prescription. Currently, consumers can purchase nonprescription drugs 
from a retailer for diseases or conditions that do not meet the 
statutory criteria for prescription products and that are safe and 
effective for use in self-medication as directed in the labeling. (See 
21 U.S.C. 353(b).) Generally, OTC products: (1) Are available to treat 
diseases or conditions that can be self-diagnosed without a prior 
interaction with a practitioner, (2) are not associated with toxicities 
that require an evaluation of the benefits and risks by a practitioner; 
and (3) do not require a practitioner's input for use.

B. Undertreatment of Diseases and Other Effects on the Health Care 

    Undertreatment of many common diseases or conditions in the United 
States is a well recognized public health problem. Increasing the 
number of people who are able to obtain for the first time and those 
who continue on necessary drug therapy could provide improved health 
outcomes. The requirement to obtain a prescription for appropriate 
medication (and to make one or more visits to a practitioner) may 
contribute to undertreatment of certain common medical conditions 

[[Page 12060]]

hyperlipidemia (high cholesterol), hypertension (high blood pressure), 
migraine headaches, and asthma. For instance, some consumers do not 
seek necessary medical care, which may include prescription drug 
therapy, because of the cost and time required to visit a health care 
practitioner for an initial diagnosis and an initial prescription. Some 
patients who obtain an initial prescription do not continue on 
necessary medication because they would need to make additional visits 
to a health care practitioner for a prescription refill after any 
refills authorized by the initial prescription have been used or the 
time during which they can be filled has expired. Some prescription 
medications require routine monitoring through the prescribing 
practitioner such as blood tests to assist in the diagnosis of a 
condition, or to determine whether or how well the medication is 
working, or to adjust the dose. FDA believes that some of these visits 
could be eliminated by making certain prescription medications 
available without a prescription but with certain other conditions of 
safe use that would ensure they could be used safely and effectively 
without the initial involvement of a health care practitioner. In some 
cases, a visit to a practitioner would be required for the initial 
prescription, but a certain number of refills could be authorized 
beyond those that would normally be authorized without a return visit 
under specialized conditions of safe use. This paradigm might be useful 
for certain rescue medicines, such as inhalers used to treat asthma or 
epinephrine for allergic reactions, that patients need to keep on hand 
for use in emergencies. In addition to improved health outcomes for 
consumers staying on their medications, the time and attention that 
physicians and other health care providers expend on routine tasks 
related to prescription refills reduces the time that they are 
available to attend to more seriously ill patients. Eliminating or 
reducing the number of routine visits could free up prescribers to 
spend time with more seriously ill patients, reduce the burdens on the 
already overburdened health care system, and reduce health care costs.

II. New Paradigm

    FDA is considering whether medications for certain diseases or 
conditions that would otherwise be available only by prescription could 
be made available without a prescription with certain conditions of 
safe use. For example, some conditions of safe use could be designed to 
assist patients in self-selection of an appropriate medication or 
provide for followup monitoring during continued use. The conditions of 
use could include requiring pharmacist intervention to ensure 
appropriate nonprescription use. Additionally, conditions of safe use 
could involve the use of innovative technologies, such as diagnostics 
approved or cleared by FDA for use in the pharmacy or other setting.
    FDA is aware that industry is developing new technologies that 
consumers could use to self-screen for a particular disease or 
condition and determine whether a particular medication is appropriate 
for them. For example, kiosks or other technological aids in pharmacies 
or on the Internet could lead consumers through an algorithm for a 
particular drug product. Such an algorithm could consist of a series of 
questions that help consumers properly self-diagnose certain medical 
conditions, or determine whether specific medication warnings 
contraindicate their use of a drug product. In addition, for some drug 
products that require an initial prescription, the product could be 
made available as a nonprescription product with a condition of safe 
use for the purpose of product refills.
    In addition, some drug products that would otherwise require a 
prescription could be approved as nonprescription drug products with 
some type of pharmacist intervention as their condition of safe use. 
For example, some diseases or conditions might require confirmation of 
a diagnosis or routine monitoring using a diagnostic test (e.g., a 
blood test for cholesterol levels or liver function) that could be 
available in a pharmacy. A pharmacist, or consumer, could then use the 
results to determine whether use of a certain drug product is 
appropriate. Other potential roles for the pharmacist include assessing 
whether the consumer has any conditions or other risk factors that 
would indicate that the drug should not be used, or assisting the 
consumer in choosing between various drug products. For drugs that 
require use of a diagnostic test, creating a pathway for 
nonprescription use may result in the development by industry of 
diagnostics suitable for use by the patient or a pharmacy professional.
    FDA is also considering whether the same drug product could be 
simultaneously available as both a prescription and nonprescription 
product with conditions of safe use. Dual availability could help 
ensure greater access to needed medications by making obtaining them 
more flexible. Consumers could choose to continue seeing their health 
care practitioner to diagnose diseases or conditions and obtain 
prescriptions, and when their local retail establishment is not 
equipped to offer the nonprescription product with conditions of safe 
use. Other consumers could take advantage of the ability to obtain 
nonprescription products with conditions of safe use where they are 
    FDA is seeking input on what types of evidence would be needed to 
demonstrate that certain drugs could be used safely and effectively in 
the nonprescription setting with conditions of safe use. We anticipate 
that, depending upon the situation, applications for approval of 
nonprescription products with conditions of safe use may need to 
include patient studies (e.g., self-selection studies, label 
comprehension studies, and actual use studies) to demonstrate that the 
drug would be safe and effective under the specified conditions. When a 
device, e.g., diagnostic test or computer algorithm, is necessary as a 
condition of safe use, evidence may need to be submitted demonstrating 
that it will perform its intended function and can be appropriately 
administered in the particular setting in which it will be used. We 
expect that certain classes of drugs may be appropriate candidates for 
nonprescription use under this new paradigm, but FDA would need to 
evaluate each NDA, and when applicable, each device, on a case-by-case 

III. Scope of the Public Hearing

    FDA is holding this public hearing to seek input from interested 
members of the public including consumers, pharmacists, physicians and 
other members of the medical community, regulated industry, insurers, 
and managed care organizations on a potential new paradigm to allow 
certain drugs that would otherwise require a prescription to be 
approved as nonprescription drugs with conditions of safe use. FDA is 
interested in obtaining information and public comment on the following 

A. Types of Technology and Conditions of Safe Use

    1. Can you suggest specific medical conditions or diseases for 
which consumers may benefit if the treatment drug were available as a 
nonprescription product with conditions of safe use?
    2. What types of technologies (e.g., kiosks, computer algorithms) 
are currently in development that could assist in allowing drugs to be 
used safely and effectively in the nonprescription setting?

[[Page 12061]]

    3. What other types of conditions of safe use (e.g., pharmacy 
monitoring or counseling) could be used to help ensure the safe and 
effective use of certain drug products as nonprescription products?
    4. Are there types of diagnostic aids, such as noninvasive blood 
pressure monitors and urinalysis reagent strips, that could be used in 
the nonprescription setting after appropriate FDA review, either with 
or without the aid of a pharmacist to diagnose or monitor a disease or 
    5. What data or other information exist on the use of conditions of 
safe use, including novel technologies, and on their effects on health 
care, access to medication, and/or disease and treatment education or 
    6. Are there data on how expanded access to medication or increased 
consumer education or awareness could affect patient or consumer 
behavior (e.g., by promoting patient compliance with a medication 
dosage regimen) or on health outcomes generally that would be relevant 
to the discussion of expanding the availability of nonprescription 
medications with conditions of safe use?
    7. What types of studies could be conducted to evaluate the effects 
of conditions of safe use on the safety and efficacy of particular 
drugs and on behavior and health outcomes?
    8. What types of studies could be conducted to evaluate the safety 
and efficacy of any technologies that might be relied upon as 
conditions of safe use?

B. Pharmacy, Consumer, and Health Care Provider Issues

    1. Would this new paradigm increase consumer access to necessary 
medical care?
    2. Are data available about the number of consumers who require 
drug therapy for conditions or diseases but who currently do not take 
such medication because of the burdens associated with obtaining a 
    3. Would a lack of oversight from a practitioner, including 
involvement in diagnosing the condition or monitoring for drug 
interactions or other drug effects, be a concern? If so, how could 
these concerns be addressed?
    4. How might the new paradigm be expected to affect consumers 
financially or otherwise affect access to and delivery of health care 
    5. Would expanding what could be considered nonprescription drugs 
under the new paradigm, and thus creating greater consumer access to 
needed drug products, reduce burden on emergency rooms and on 
individual health care providers, or otherwise increase the 
availability of these resources for other consumers? Are there other 
ways in which the new paradigm might reduce the burden on the health 
care system?
    6. How might various types of conditions of safe use on 
nonprescription drug products affect pharmacy business operations? What 
differences might there be in the operational issues experienced by 
pharmacies operated by chains and independently operated retail 
    7. Would additional specialized training be needed for pharmacists 
if this paradigm were adopted?
    8. If availability of a nonprescription product with conditions of 
safe use were limited to certain outlets (e.g., a chain pharmacy that 
chooses to offer a particular technology or service), would the 
situation create confusion or difficulties for consumers seeking to 
obtain the drug product? Could such a situation create difficulties for 
practitioners in knowing whether a particular consumer could access the 
drug with a prescription or would be able to obtain the same product as 
a nonprescription drug product at a retail outlet? If so, how could 
these issues be overcome?
    9. What experiences have practitioners, pharmacists, and insurers 
had with state-authorized arrangements under which access to 
prescription drugs has been expanded that might be relevant to and 
inform our consideration of this paradigm (e.g., a collaborative 
practice agreement between a pharmacist and a practitioner that allows 
the pharmacist to dispense a prescription drug to a consumer who meets 
certain criteria under a standing or open prescription, when that 
consumer did not obtain a prescription directly from a practitioner, or 
that allows a pharmacist to refill a prescription after an initial 
prescription from a practitioner pursuant to a similar agreement)?
    10. What are the public health and regulatory implications of the 
use of in vitro diagnostic tests as conditions of safe use for 
nonprescription drug products in a pharmacy setting (e.g., as a 
laboratory under the Clinical Laboratory Improvement Act of 1988 (CLIA) 
(Public Law 100-578))?

C. Other Related Issues

    1. How would insurance coverage of pharmaceuticals be affected by 
approving nonprescription products with conditions of safe use for 
widely prescribed prescription drugs under this paradigm?
    2. How would out-of-pocket costs for the insured be affected by 
making prescription drugs available as nonprescription products with 
conditions of safe use?
    3. Would the new paradigm increase liability concerns for 
pharmacists and pharmacies? To what extent would these concerns raise 
the cost of the services provided?
    4. What proprietary, technological, economic, or competitive 
barriers might impede widespread implementation of this paradigm? To 
the extent such impediments exist, are there suggestions for mitigating 
or avoiding the impediments specific to this paradigm?
    5. Would overall health care costs decrease if this paradigm were 

IV. Attendance and/or Participation in the Public Hearing

    The public hearing is free and seating will be on a first-come, 
first-served basis. Attendees who do not wish to make an oral 
presentation do not need to register.
    If you wish to make an oral presentation during the hearing, you 
must register by submitting either an electronic or a written request 
by 5 p.m. on March 9, 2012, to Lee Lemley (see FOR FURTHER INFORMATION 
CONTACT). You must provide your name, title, business affiliation (if 
applicable), address, telephone and fax numbers, email address, and 
type of organization you represent (e.g., industry, consumer 
organization). You also should submit a brief summary of the 
presentation, including the discussion topic(s) that will be addressed 
and the approximate time requested for your presentation. We encourage 
individuals and organizations with common interests to consolidate or 
coordinate their presentations to allow adequate time for each request 
for presentation. Persons registered to make an oral presentation 
should check in before the hearing.
    Participants should submit a copy of each presentation to Lee 
Lemley (see FOR FURTHER INFORMATION CONTACT) no later than March 19, 
2012. We will file the hearing schedule, indicating the order of 
presentation and the time allotted to each person, with the Division of 
Dockets Management (see ADDRESSES). Additional information will also be 
available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm289290.htm.
    We will mail, email, or telephone the schedule to each participant 
before the hearing. In anticipation of the hearing presentations moving 
ahead of schedule, participants are encouraged to arrive early to 
ensure their designated order of presentation. Participants who

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are not present when called risk forfeiting their scheduled time.
    If you need special accommodations due to a disability, contact Lee 
Lemley (see FOR FURTHER INFORMATION CONTACT) at least 7 days in 

V. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public 
hearing will be held in accordance with part 15 (21 CFR part 15). The 
hearing will be conducted by a presiding officer, who will be 
accompanied by FDA senior management from the Office of the 
Commissioner and the relevant centers.
    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 
(21 CFR 15.30(e)). 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 (21 CFR part 10), subpart C) (Sec.  
10.203(a)). 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). (See section VII of this document for 
more details.) To the extent that the conditions for the hearing as 
described in this document conflict with any provisions set out in part 
15, this document acts as a waiver of those provisions as specified in 
Sec.  15.30(h)).

VI. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments for 
consideration. Persons who wish to provide additional materials for 
consideration should file these materials with the Division of Dockets 
Management. You should annotate and organize your comments to identify 
the specific questions identified by the topic to which they refer. It 
is only necessary to send one set of comments. Identify comments with 
the docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

VII. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov. It may be viewed at 
the Division of Dockets Management (see ADDRESSES). A transcript also 
will be available in either hard copy or on CD-ROM after submission of 
a Freedom of Information request. Written requests are to be sent to 
the Division of Freedom of Information (ELEM-1029), Office of 
Management Programs, Food and Drug Administration, 12420 Parklawn Dr., 
Element Bldg., Rockville, MD 20857.

    Dated: February 23, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4597 Filed 2-27-12; 8:45 am]