Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2017-N-2936]

# 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                            ( print 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:                
    -  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                           ( print 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