[Federal Register Volume 77, Number 39 (Tuesday, February 28, 2012)]
[Notices]
[Pages 12059-12062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4597]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearing; request for comments.
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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-
0002.
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
dispensing.
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
System
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
including
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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
available.
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
basis.
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
issues:
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
condition?
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
awareness?
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
prescription?
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
generally?
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
outlets?
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
instituted?
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
advance.
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]
BILLING CODE 4160-01-P