82 FR 39598 - Content of Risk Information in the Major Statement in Prescription Drug Direct-to-Consumer Broadcast Advertisements; Establishment of a Public Docket; Request for Information and Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 160 (August 21, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 160 (August 21, 2017)
| Page Range | 39598-39600 | |
| FR Document | 2017-17563 |
[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)] [Notices] [Pages 39598-39600] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-17563] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-2936] Content of Risk Information in the Major Statement in Prescription Drug Direct-to-Consumer Broadcast Advertisements; Establishment of a Public Docket; Request for Information and Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of a public docket; request for information and comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is establishing a public docket to assist with its development of recommendations regarding the communication of risk information in direct-to-consumer (DTC) broadcast advertisements for prescription drugs and biologics. DATES: Although you can comment at any time, to ensure that the Agency considers your comment in our development of recommendations, submit either electronic or written information and comments by November 20, 2017. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-N-2936 for ``Content of Risk Information in the Major Statement in Prescription Drug Direct-to-Consumer Broadcast Advertisements.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly [[Page 39599]] available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Regarding human prescription drugs: Julie Chronis, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3203, Silver Spring, MD 20993-0002, 301-796-1200. Regarding human prescription biological products: Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background The prescription drug advertising regulations require that broadcast advertisements containing product claims include information relating to the advertised drug's major side effects and contraindications in either the audio or audio and visual parts of the advertisement (21 CFR 202.1(e)(1)); this is often called the major statement. The regulations also require that broadcast advertisements contain a brief summary of all necessary information related to side effects and contraindications or that ``adequate provision'' be made for dissemination of the approved package labeling in connection with the broadcast presentation (21 CFR 202.1(e)(1)). This requirement to make ``adequate provision'' is generally fulfilled when a firm gives consumers the option of obtaining the FDA-required labeling or other information via a toll-free telephone number, through print advertisements or product brochures, through information disseminated at health care provider offices or pharmacies, and through the internet. See the guidance for industry entitled ``Consumer-Directed Broadcast Advertisements,'' available at http://www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm234622.htm. From a public health standpoint, FDA is interested in helping to ensure that when firms choose to advertise directly to consumers and patients, such advertisements provide clear and useful information to that audience. There is concern that the major statement, as currently implemented in DTC broadcast advertisements for prescription drugs, is not fulfilling this purpose. Some believe it is often too long, which may result in reduced consumer comprehension, minimization of important risk information, and, potentially, therapeutic noncompliance caused by fear of side effects (Ref. 1). At the same time, there is concern that DTC broadcast advertisements do not include adequate risk information or that they leave out important information (Refs. 2 and 3). The Office of Prescription Drug Promotion (OPDP) within FDA's Center for Drug Evaluation and Research (CDER) is investigating through empirical research the effectiveness of a limited risks plus disclosure strategy to inform the Agency's decision making in this area. (For more information about OPDP's proposed study, see 79 FR 9217, February 18, 2014.) Through the research and through this request for information and comments, OPDP is exploring the usefulness of limiting the risks in the major statement for most DTC broadcast advertisements for prescription drugs to those that are severe (life-threatening), serious, or actionable, coupled with a disclosure to alert consumers that there are other product risks not included in the advertisement. (For example, a disclosure could be, ``This is not a full list of risks and side effects. Talk to your health care provider and read the patient labeling for more information.'') For the purposes of this request for information and comments, please consider the following definitions: Severe risk--a serious risk that is life-threatening (see serious risk). Serious risk--the risk of reactions from using the drug that may result in inpatient hospitalization or prolonged existing hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect. Reactions that do not require hospitalization, cause a disability, or cause a birth defect may still be considered serious risks when, based on appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes previously listed. Actionable risk--a risk the patient would know (e.g., pre- existing condition or allergy) or recognize (e.g., observable physical or mental symptom) and can act upon to help mitigate the risk (e.g., get immediate medical help to prevent a bad outcome); for example, ``Stop using the product and get immediate medical help if you have swelling of the face, lips, tongue, or throat.'' However, we note that while some drug products may not have severe, serious, or actionable risks as described in this document, all DTC prescription drug broadcast advertisements are required to present a fair balance of risk information when presenting information relating to the effectiveness of the drug (21 CFR 202.1(e)(5)). Therefore, to avoid a misleading presentation regarding a drug's risk-benefit profile, prescription drug advertisements that provide information about a drug's effectiveness would be expected to contain some risk information, even if the risks are not severe, serious, or actionable. II. Request for Information and Comments Interested persons are invited to provide detailed information and comments on the content of risk information in DTC broadcast advertisements for prescription drugs. FDA is particularly interested in responses to the following questions: 1. What data are available regarding the impact of the current approaches to communication of risk information in DTC prescription drug broadcast advertisements on consumer comprehension of the information in the advertisement, including the impact on comprehension of product benefits and risk information? 2. What are the potential effects of only including risks from the FDA-approved product labeling that are severe, serious, or actionable (as previously defined) in the major statements of DTC prescription drug broadcast advertisements? Are there other ways of characterizing which risks should be included in the major statement? Please explain. 3. When a DTC prescription drug broadcast advertisement presents information relating to the effectiveness of a prescription drug that does not have severe, serious, or actionable risks, what types of risk could be included in the major statement? 4. What criteria should be used to distinguish risk information that is most [[Page 39600]] material to patient or consumer audiences versus risk information that is material primarily to the prescriber or other health care providers? What data are available to answer this question? 5. What criteria should be used to determine which risk information that is material to patient or consumer audiences to include in the major statement for DTC prescription drug broadcast advertisements to best protect the public health? What data are available to answer this question? 6. What is the potential impact of including (or conversely, of not including), in the major statement for DTC prescription drug broadcast advertisements, additional language that states that there are other risks not included in the advertisement while simultaneously encouraging dialogue between patients and their health care providers? (For example, additional language could include, ``This is not a full list of risks and side effects. Talk to your health care provider and read the patient labeling for more information.'') What data are available to answer this question? 7. What data are available on consumers' comprehension of the difference between levels (i.e., severity) of risk? Would it be in the interest of public health to include a signal before the risk information that frames and categorizes the overall level of risk associated with the product? One approach may be to include an opening statement tailored to the risk profile of the drug. For example, drugs could be divided into three defined categories and include the corresponding opening statements: a. For drugs with severe, life-threatening risks: ``[Drug] can cause severe, life-threatening reactions. These include . . . .'' b. For drugs with serious but not life-threatening risks: ``[Drug] can cause serious reactions. These include . . . .'' c. For drugs with no severe or serious risks: ``[Drug] can cause reactions. These include . . . .'' 8. Should potential food and drug interactions be disclosed in DTC prescription drug broadcast advertisements, and if so, what criteria should be used to identify these interactions? FDA will consider all information and comments submitted. III. References The following references are on display in the Dockets Management Staff office (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. 1. Delbaere, M. and M.C. Smith, ``Health Care Knowledge and Consumer Learning: The Case of Direct-to-Consumer Drug Advertising,'' Health Marketing Quarterly, vol. 23, issue 3, pp. 9- 29, 2006. 2. Friedman, M. and J. Gould, ``Consumer Attitudes and Behaviors Associated With Direct-to-Consumer Prescription Drug Marketing,'' Journal of Consumer Marketing, vol. 24, issue 2, pp. 100-109, 2007. 3. Frosch, D.L., P.M. Krueger, R.C. Hornik, P.F. Cronholm, and F.K. Barg, ``Creating Demand for Prescription Drugs: A Content Analysis of Television Direct-to-Consumer Advertising,'' The Annals of Family Medicine, vol. 5, issue 1, pp. 6-13, 2007. Dated: August 15, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-17563 Filed 8-18-17; 8:45 am] BILLING CODE 4164-01-P
![39598 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Recognition No. Title of standard 1 Reference No. and date
S. Tissue Engineering
15–50 ................................... Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds .......... ASTM F2739–16.
1 All standard titles in this table conform to the style requirements of the respective organizations.
IV. List of Recognized Standards DEPARTMENT OF HEALTH AND comments, that information will be
HUMAN SERVICES posted on https://www.regulations.gov.
FDA maintains the current list of FDA • If you want to submit a comment
Recognized Consensus Standards in a Food and Drug Administration with confidential information that you
searchable database that may be do not wish to be made available to the
[Docket No. FDA–2017–N–2936]
accessed at https:// public, submit the comment as a
www.accessdata.fda.gov/scripts/cdrh/ Content of Risk Information in the written/paper submission and in the
cfdocs/cfStandards/search.cfm. FDA Major Statement in Prescription Drug manner detailed (see ‘‘Written/Paper
will be incorporating the modifications Direct-to-Consumer Broadcast Submissions’’ and ‘‘Instructions’’).
and revisions described in this notice Advertisements; Establishment of a Written/Paper Submissions
into the database and, upon publication Public Docket; Request for Information
in the Federal Register, this recognition and Comments Submit written/paper submissions as
follows:
of consensus standards will be effective. • Mail/Hand delivery/Courier (for
AGENCY: Food and Drug Administration,
FDA will be announcing additional HHS. written/paper submissions): Dockets
modifications and revisions to the list of Management Staff (HFA–305), Food and
ACTION: Notice; establishment of a
recognized consensus standards in the Drug Administration, 5630 Fishers
public docket; request for information
Federal Register, as needed, once a and comments. Lane, Rm. 1061, Rockville, MD 20852.
year, or more often if necessary. • For written/paper comments
SUMMARY: The Food and Drug submitted to the Dockets Management
V. Recommendation of Standards for Administration (FDA, the Agency, or Staff, FDA will post your comment, as
Recognition by FDA we) is establishing a public docket to well as any attachments, except for
Any person may recommend assist with its development of information submitted, marked and
consensus standards as candidates for recommendations regarding the identified, as confidential, if submitted
recognition under section 514 of the communication of risk information in as detailed in ‘‘Instructions.’’
direct-to-consumer (DTC) broadcast Instructions: All submissions received
FD&C Act by submitting such
advertisements for prescription drugs must include the Docket No. FDA–
recommendations, with reasons for the
and biologics. 2017–N–2936 for ‘‘Content of Risk
recommendation, to
DATES: Although you can comment at Information in the Major Statement in
CDRHStandardsStaff@fda.hhs.gov. To
any time, to ensure that the Agency Prescription Drug Direct-to-Consumer
be considered, such recommendations Broadcast Advertisements.’’ Received
considers your comment in our
should contain, at a minimum, the comments will be placed in the docket
development of recommendations,
following information: (1) Title of the submit either electronic or written and, except for those submitted as
standard, (2) any reference number and information and comments by ‘‘Confidential Submissions,’’ publicly
date, (3) name and electronic or mailing November 20, 2017. viewable at https://www.regulations.gov
address of the requestor, (4) a proposed ADDRESSES: You may submit comments or at the Dockets Management Staff
list of devices for which a declaration of as follows: between 9 a.m. and 4 p.m., Monday
conformity to this standard should through Friday.
routinely apply, and (5) a brief Electronic Submissions • Confidential Submissions—To
identification of the testing or Submit electronic comments in the submit a comment with confidential
performance or other characteristics of following way: information that you do not wish to be
the device(s) that would be addressed • Federal eRulemaking Portal: made publicly available, submit your
by a declaration of conformity. https://www.regulations.gov. Follow the comments only as a written/paper
instructions for submitting comments. submission. You should submit two
Dated: August 16, 2017.
Comments submitted electronically, copies total. One copy will include the
Leslie Kux, including attachments, to https:// information you claim to be confidential
Associate Commissioner for Policy. www.regulations.gov will be posted to with a heading or cover note that states
[FR Doc. 2017–17603 Filed 8–18–17; 8:45 am] the docket unchanged. Because your ‘‘THIS DOCUMENT CONTAINS
BILLING CODE 4164–01–P comment will be made public, you are CONFIDENTIAL INFORMATION.’’ The
solely responsible for ensuring that your Agency will review this copy, including
comment does not include any the claimed confidential information, in
asabaliauskas on DSKBBXCHB2PROD with NOTICES
confidential information that you or a its consideration of comments. The
third party may not wish to be posted, second copy, which will have the
such as medical information, your or claimed confidential information
anyone else’s Social Security number, or redacted/blacked out, will be available
confidential business information, such for public viewing and posted on
as a manufacturing process. Please note https://www.regulations.gov. Submit
that if you include your name, contact both copies to the Dockets Management
information, or other information that Staff. If you do not wish your name and
identifies you in the body of your contact information to be made publicly
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![39600 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices
material to patient or consumer available electronically at https:// encourage the availability of an
audiences versus risk information that is www.regulations.gov. adequate supply of safe and effective
material primarily to the prescriber or 1. Delbaere, M. and M.C. Smith, ‘‘Health vaccination products in the United
other health care providers? What data Care Knowledge and Consumer Learning: States; (2) recommends research
are available to answer this question? The Case of Direct-to-Consumer Drug priorities and other measures the
5. What criteria should be used to Advertising,’’ Health Marketing Quarterly, Director of the NVP should take to
determine which risk information that is vol. 23, issue 3, pp. 9–29, 2006. enhance the safety and efficacy of
material to patient or consumer 2. Friedman, M. and J. Gould, ‘‘Consumer vaccines; (3) advises the Director of the
audiences to include in the major Attitudes and Behaviors Associated With NVP in the implementation of Sections
statement for DTC prescription drug Direct-to-Consumer Prescription Drug 2102 and 2103 of the PHS Act; and (4)
Marketing,’’ Journal of Consumer Marketing, identifies annually for the Director of
broadcast advertisements to best protect
vol. 24, issue 2, pp. 100–109, 2007.
the public health? What data are 3. Frosch, D.L., P.M. Krueger, R.C. Hornik,
the NVP the most important areas of
available to answer this question? P.F. Cronholm, and F.K. Barg, ‘‘Creating governmental and non-governmental
6. What is the potential impact of Demand for Prescription Drugs: A Content cooperation that should be considered
including (or conversely, of not Analysis of Television Direct-to-Consumer in implementing Sections 2101 and
including), in the major statement for Advertising,’’ The Annals of Family 2103 of the PHS Act.
DTC prescription drug broadcast Medicine, vol. 5, issue 1, pp. 6–13, 2007. On July 21, 2017, the Acting Assistant
advertisements, additional language that Dated: August 15, 2017. Secretary for Health approved renewal
states that there are other risks not of the NVAC charter with minor
Leslie Kux,
included in the advertisement while amendments. The new charter was
Associate Commissioner for Policy.
simultaneously encouraging dialogue effected and filed with the appropriate
[FR Doc. 2017–17563 Filed 8–18–17; 8:45 am] Congressional committees and Library
between patients and their health care
providers? (For example, additional BILLING CODE 4164–01–P of Congress on July 30, 2017. Renewal
language could include, ‘‘This is not a of the NVAC charter gives authorization
full list of risks and side effects. Talk to for the Committee to continue to operate
DEPARTMENT OF HEALTH AND until July 30, 2019.
your health care provider and read the
HUMAN SERVICES A copy of the NVAC charter is
patient labeling for more information.’’)
What data are available to answer this available on the Web site for the
Charter Renewal of the National National Vaccine Program Office at
question? Vaccine Advisory Committee
7. What data are available on http://www.hhs.gov/nvpo/nvac. A copy
consumers’ comprehension of the AGENCY: National Vaccine Program of the charter also can be obtained by
difference between levels (i.e., severity) Office, Office of the Assistant Secretary accessing the FACA database that is
of risk? Would it be in the interest of for Health, Office of the Secretary, maintained by the Committee
public health to include a signal before Department of Health and Human Management Secretariat under the
the risk information that frames and Services. General Services Administration. The
categorizes the overall level of risk ACTION: Notice. Web site address for the FACA database
associated with the product? One is http://www.facadatabase.gov/.
approach may be to include an opening SUMMARY: The Department of Health and Dated: August 14, 2017.
statement tailored to the risk profile of Human Services is hereby giving notice Melinda Wharton,
the drug. For example, drugs could be that the charter for the National Vaccine Acting Director, National Vaccine Program
divided into three defined categories Advisory Committee (NVAC) has been Office.
and include the corresponding opening renewed. [FR Doc. 2017–17527 Filed 8–18–17; 8:45 am]
statements: FOR FURTHER INFORMATION CONTACT: BILLING CODE 4150–44–P
a. For drugs with severe, life- National Vaccine Program Office, U.S.
threatening risks: ‘‘[Drug] can cause Department of Health and Human
severe, life-threatening reactions. These Services, Room 715H, Hubert H. DEPARTMENT OF HEALTH AND
include . . . .’’ Humphrey Building, 200 Independence HUMAN SERVICES
b. For drugs with serious but not life- Avenue SW., Washington, DC 20201.
threatening risks: ‘‘[Drug] can cause Phone: (202) 690–5566; email: nvac@ Indian Health Service
serious reactions. These include . . . .’’ hhs.gov.
c. For drugs with no severe or serious Division of Behavioral Health; Office of
risks: ‘‘[Drug] can cause reactions. These SUPPLEMENTARY INFORMATION: NVAC is a Clinical and Preventive Services; Zero
include . . . .’’ non-discretionary Federal advisory Suicide Initiative—Support
8. Should potential food and drug committee. The establishment of NVAC
was mandated under Section 2105 (42 Announcement Type: New.
interactions be disclosed in DTC Funding Announcement Number:
prescription drug broadcast U.S.C. Section 300aa–5) of the Public
Health Service Act, as amended (PHS HHS–2018–IHS–ZSI–0001.
advertisements, and if so, what criteria Catalog of Federal Domestic
should be used to identify these Act). The Committee is governed by
Assistance Number: 93.933.
interactions? provisions of the Federal Advisory
FDA will consider all information and Committee Act (FACA), Public Law 92– Key Dates
asabaliauskas on DSKBBXCHB2PROD with NOTICES
comments submitted. 463, as amended (5 U.S.C. App.). NVAC Application Deadline Date: October
advises and makes recommendations to 12, 2017.
III. References the Director, National Vaccine Program Review Date: October 16–20, 2017.
The following references are on (NVP), on matters related to the Earliest Anticipated Start Date:
display in the Dockets Management Program’s responsibilities. The November 1, 2017.
Staff office (see ADDRESSES) and are Assistant Secretary for Health is Signed Tribal Resolution Due Date:
available for viewing by interested appointed to serve as the Director, NVP. October 12, 2017.
persons between 9 a.m. and 4 p.m., To carry out its mission, NVAC (1) Proof of Non-Profit Status Due Date:
Monday through Friday; they are also studies and recommends ways to October 12, 2017.
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Document Created: 2017-08-19 00:44:41
Document Modified: 2017-08-19 00:44:41
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; establishment of a public docket; request for information and comments. | |
| Dates | Although you can comment at any time, to ensure that the Agency considers your comment in our development of recommendations, submit either electronic or written information and comments by November 20, 2017. | |
| Contact | Regarding human prescription drugs: Julie Chronis, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3203, Silver Spring, MD 20993-0002, 301-796-1200. | |
| FR Citation | 82 FR 39598 |
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