[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)]
[Notices]
[Pages 39598-39600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.gpo.gov/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:
    <bullet> Severe risk--a serious risk that is life-threatening (see 
serious risk).
    <bullet> 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.
    <bullet> 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