PhRMA GUIDING PRINCIPLES
DIRECT TO CONSUMER ADVERTISEMENTS
ABOUT PRESCRIPTION MEDICINES
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P hRMA GUIDING PRINCIPLES
DIRECT TO CONSUMER ADVERTISEMENTS ABOUT PRESCRIPTION MEDICINES
PREAMBLE
Given the progress that continues to be made in society’s battle against disease, patients are seeking more
information about medical problems and potential treatments so they can better understand their health
care options and communicate eectively with their physicians. An important benefit of direct to consumer
(DTC) advertising is that it fosters an informed conversation about health, disease and treatments between
patients and their health care practitioners.
A strong empirical record demonstrates that DTC communications about prescription medicines serve the
public health by:
• Increasing awareness about diseases;
• Educating patients about treatment options;
• Motivating patients to contact their physicians and engage in a dialogue about health concerns;
• Increasing the likelihood that patients will receive appropriate care for conditions that are
frequently under-diagnosed and under-treated; and
• Encouraging compliance with prescription drug treatment regimens.
The Pharmaceutical Research and Manufacturers of America (PhRMA), represents America’s leading
innovative biopharmaceutical research companies. As the companies responsible for developing new and
innovative medicines, PhRMA members want patients and consumers to talk to their physicians about the
medicines that may help them and to fully understand the known risks regarding these medicines. We know
that DTC communications, particularly DTC television advertising, can be a powerful tool for reaching and
educating millions of people, and we are committed to ensuring that our DTC communications provide
accurate, accessible and useful health information to patients and consumers. DTC advertising of such
important and innovative products as prescription drugs should be responsibly designed to achieve these
goals and to encourage the appropriate use of these products.
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First and foremost, we have a responsibility to ensure that our DTC communications comply with the
regulations of the Food and Drug Administration (FDA). In general, the FDA requires all DTC information:
• To be accurate, truthful and not misleading;
• To make claims only when supported by appropriate evidence;
• To reflect balance between risks and benefits; and
• To be consistent with the FDA-approved labeling.
Innovative biopharmaceutical companies take their responsibilities to comply with FDA requirements
seriously. Companies devote substantial time and eort, and often ask for input from FDA, to ensure that
DTC communications are accurate, fairly balanced and meet all applicable legal requirements. PhRMA
member companies will engage in a dialogue with FDA to maximize opportunities for FDA review of DTC
advertising prior to release, consistent with these Principles and the Agency’s priorities and resources.
Beyond meeting their legal obligations, companies strive to deliver messages that fundamentally serve to
educate patients and consumers and encourage them to seek guidance from their health care professionals.
PhRMA member companies recognize that patients and consumers could also benefit from greater
transparency and education about access to medicines, including the potential costs and available company
resources that may help patients with the cost of their medicine.
To express the commitment of PhRMA members to deliver DTC communications that serve as valuable
contributors to public health, PhRMA has established the following voluntary Guiding Principles, which were
revised in October 2018. This version of PhRMA’s Guiding Principles will become eective April 15, 2019.
Guiding Principles Direct to Consumer Advertisements About Prescription Medicines
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GUIDING PRINCIPLES
1. These Principles are premised on the recognition that DTC advertising of prescription medicines can
benefit the public health by increasing awareness about diseases, educating patients about treatment
options, motivating patients to contact their physicians and engage in a dialogue about health concerns,
increasing the likelihood that patients will receive appropriate care for conditions that are frequently
under-diagnosed and under-treated, and encouraging compliance with prescription drug treatment
regimens.
2. In accordance with FDA regulations, all DTC information should be accurate, truthful and not misleading,
should make claims only when supported by appropriate evidence, should reflect balance between risks
and benefits, and should be consistent with FDA approved labeling. Accordingly, companies should
continue to base promotional claims on FDA approved labeling and not promote medicines for o-label
uses, including in DTC advertisements.
3. DTC television and print advertising which is designed to market a prescription drug should also be
designed to responsibly educate the consumer about that medicine and, where appropriate, the condition
for which it may be prescribed. During the development of new DTC television advertising campaigns,
companies should seek and consider feedback from appropriate audiences, such as health care
professionals and patients, to gauge the educational impact for patients and consumers.
4. DTC television and print advertising of prescription drugs should clearly indicate that the medicine is a
prescription drug to distinguish such advertising from other advertising for non-prescription products.
5. DTC television and print advertising should foster responsible communications between patients and
health care professionals to help patients achieve better health and a more complete appreciation of both
the health benefits and the known risks associated with the medicine being advertised.
6. In order to foster responsible communication between patients and health care professionals, companies
should spend an appropriate amount of time to educate health professionals about a new medicine or a
new therapeutic indication and to alert them to the upcoming advertising campaign before commencing
the first DTC advertising campaign. In determining what constitutes an appropriate time, companies
should take into account the relative importance of informing patients of the availability of a new
medicine, the complexity of the risk-benefit profile of that new medicine and health care professionals’
knowledge of the condition being treated. Companies are encouraged to consider individually setting
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specific periods of time, with or without exceptions, to educate health care professionals before launching
a branded DTC television or print advertising campaign. Companies should continue to educate health
care professionals as additional valid information about a new medicine is obtained from all reliable
sources.
7. Working with the FDA, companies should continue to responsibly alter or discontinue a DTC advertising
campaign should new and reliable information indicate a serious previously unknown safety risk.
8. Companies should submit all new DTC television advertisements to the FDA before releasing these
advertisements for broadcast.
9. DTC print advertisements for prescription medicines should include FDA’s toll-free MedWatch telephone
number and website for reporting potential adverse events. DTC television advertisements for prescription
medicines should direct patients to a print advertisement containing FDA’s toll-free MedWatch telephone
number and website, and/or should provide the company’s toll-free telephone number.
10. Companies that choose to feature actors in the roles of health care professionals in a DTC television or
print advertisement that identifies a particular product should acknowledge in the advertisement that
actors are being used. Likewise, if actual health care professionals appear in such advertisements, the
advertisement should include an acknowledgment if the health care professional is compensated for the
appearance.
11. Where a DTC television or print advertisement features a celebrity endorser, the endorsements should
accurately reflect the opinions, findings, beliefs or experience of the endorser. Companies should maintain
verification of the basis of any actual or implied endorsements made by the celebrity endorser in the DTC
advertisement, including whether the endorser is or has been a user of the product if applicable.
12. DTC television and print advertising should include information about the availability of other options
such as diet and lifestyle changes where appropriate for the advertised condition.
13. DTC television advertising that identifies a product by name should clearly state the health conditions for
which the medicine is approved and the major risks associated with the medicine being advertised.
Guiding Principles Direct to Consumer Advertisements About Prescription Medicines
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14. DTC television and print advertising should be designed to achieve a balanced presentation of both the
benefits and the risks associated with the advertised prescription medicine. Specifically, risks and safety
information, including the substance of relevant boxed warnings, should be presented with reasonably
comparable prominence to the benefit information, in a clear, conspicuous and neutral manner, and
without distraction from the content. In addition, DTC television advertisements should support
responsible patient education by directing patients to health care professionals as well as to print
advertisements and/or websites where additional benefit and risk information is available.
15. All DTC advertising should respect the seriousness of the health conditions and the medicine being
advertised.
16. In terms of content and placement, DTC television and print advertisements should be targeted to avoid
audiences that are not age appropriate for the messages involved. In particular, DTC television and print
advertisements containing content that may be inappropriate for children should be placed in programs
or publications that are reasonably expected to draw an audience of approximately 90 percent adults (18
years or older).
17. Companies are encouraged to promote health and disease awareness as part of their DTC advertising.
18. Companies should include information in all DTC advertising, where practical and appropriate, directing
patients to company resources that may help them with the cost of their medicine.
19. All DTC television advertising that identifies a prescription medicine by name should include direction
as to where patients can find information about the cost of the medicine, such as a company-developed
website, including the list price and average, estimated or typical patient out-of-pocket costs, or other
context about the potential cost of the medicine.
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ADHERENCE TO THE GUIDING PRINCIPLES
Companies that voluntarily and independently commit to abide by these revised Guiding Principles are
committing to establish internal processes to foster compliance. Companies that do so will be identified on
the PhRMA website as signatories, and will have the option to complete an annual submission to certify that
the Company has put in place policies and procedures to foster compliance with the Principles. The annual
certification must be signed by the company’s Chief Executive Ocer and Chief Compliance Ocer. Any
Company that completes the annual certification process will be identified on the PhRMA website at the
appropriate time.
If any member of the general public or any health care professional contacts PhRMA regarding the
compliance of any signatory company, those comments will be communicated to the Company in question.
PhRMA will provide directions on its website about how members of the general public or any healthcare
professionals can submit comments. PhRMA will issue an annual report summarizing the nature of any
comments received and will provide a copy of the report to the FDA.
Guiding Principles Direct to Consumer Advertisements About Prescription Medicines
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PhRMA Guiding Principles
Direct to Consumer Advertisements About Prescription Medicines
QUESTIONS AND ANSWERS
Q1: What is meant by a “direct to consumer television advertisement” in the context of these Principles?
A1: A direct to consumer television advertisement is a portion of television air time on broadcast or cable
television that is bought by a company for the purpose of presenting information about one or more of
the company’s medicines. A DTC television advertisement does not include sponsorship of activities.
Q2: What is meant by “direct to consumer print advertisement” in the context of these Principles?
A2: A direct to consumer print advertisement is space that is bought by a company in newspaper or
magazine publications targeted to patients or consumers, or a direct mail communication paid for and
disseminated by a company to patients or consumers, for the purpose of presenting information about
one or more of the company’s medicines. A DTC print advertisement does not include sponsorship of
activities.
Q3: How long must a company wait under Principle 6 before advertising a new medicine after the
medicine is approved by FDA?
A3: Principle 6 demonstrates the companies’ commitment to devote sucient resources and time to health
care professional education before launching a direct to consumer advertising campaign. Principle 6
ensures that health care professionals will have a reasonable opportunity to learn about new medications
before their patients ask questions about them so they will have accurate, up-to-date information
to use in responding to patients’ inquiries and guiding patients to the most appropriate treatment
option. Establishing a single uniform waiting period for all companies and all medicines could have
the unintended consequence of denying patients important information about new medicines, even
after health care professionals have been well educated. In setting the appropriate periods of time,
companies may consider adjusting the periods to take into account such factors as the level of health
care professional awareness of the new medicine or indication.
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Q4: What considerations should a company take into account in designing a program to educate health
care professionals before commencing the first DTC advertising campaign?
A4: Each company will decide for itself how best to implement an eective educational program, taking
into account such factors as health care professionals’ knowledge of the condition being treated, the
severity and/or prevalence of the condition, the novelty of the new treatment, and the complexity of
the medicine’s risk-benefit profile and directions for use. Companies should make reasonable eorts
to reach out to relevant health care professionals who would be interested in learning about the new
medicine or indication.
Q5: Does Principle 8 require companies to do more than what is already required under current FDA
regulations?
A5: Yes. Current law provides that companies must submit their DTC television advertisements to FDA
upon first use of the advertisement (among other requirements) for FDA’s review at its discretion. In
addition, FDA may require submission of certain television advertisements for a drug prior to use of
the advertisement. For products approved via the accelerated approval pathway, submission of such
advertisements to FDA prior to use of the advertisement is required. Under Principle 8, while not
intending to place additional burdens on FDA, companies commit to submitting new DTC television
advertisements to FDA within a reasonable time in advance of first use of the advertisement even if not
legally required to give FDA the opportunity to comment, consistent with its priorities and resources.
(See Q & A 8 for further information about advertisements that warrant submission). Companies also
commit to inform FDA when they submit an advertisement of the earliest date the advertisement is
scheduled to air.
Q6: Should companies notify FDA if they are specifically requesting feedback on a particular
advertisement submitted under Principle 8?
A6: In order to permit FDA to allocate its resources eectively, companies should notify FDA if they are
specifically requesting feedback on a submitted DTC advertisement. Companies also should indicate
whether the requested FDA review is time-sensitive to help FDA prioritize its review activities. As a
general matter, we understand that FDA expects companies to submit the following information with
the submitted DTC advertisement: (1) a statement indicating whether the company is submitting the
advertisement for prior Agency review and feedback, or for the Agency’s information; (2) if feedback is
requested, a statement identifying whether the company is requesting FDA review on a priority basis;
(3) a brief description of the reasons for any request for priority review (e.g., identifying the basis for the
submission and the nature of any change the company deems significant); and (4) the earliest date
Guiding Principles Direct to Consumer Advertisements About Prescription Medicines
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the company plans to finalize the advertisement. Companies typically should reserve a priority review
request for those submissions that are most time-sensitive, keeping in mind that FDA may choose to
review only one iteration of a particular new DTC advertisement on a priority basis.
Q7: PhRMA states that, under Principle 8, companies should submit new DTC television advertisements
to the FDA a reasonable time before releasing the advertisement for broadcast to give FDA the
opportunity to comment, consistent with its priorities and resources. What constitutes “a reasonable
time” in this context?
A7: The precise time frame for submission of a particular DTC advertisement will vary depending
on the advertisement in question and purpose of the submission. If a company is specifically
requesting feedback from FDA, either by priority review or standard review, it should submit the
DTC advertisement far enough in advance to permit the Agency to perform the requested review.
Although the timing of FDA’s review of DTC advertisements will be dictated by the Agency’s priorities
and resources, a company seeking priority review will maximize its opportunity to receive comments
from the Agency if the company allows 30 calendar days for FDA review and comment. A company
seeking non-priority review for a particular advertisement should try to allow more than 30 calendar
days for FDA review, while less lead time could be appropriate if a company is submitting a particular
advertisement for the Agency’s information.
Q8: Does Principle 8 require companies to submit a revised DTC television advertisement to FDA
in advance, even if the advertisement reflects only minor changes to a previously submitted
advertisement?
A8: No. Under Principle 8, companies should submit only new television advertisements or advertisements
that have been changed in a way that the companies believe is significant. For instance, where a
company changes an existing advertisement—possibly by changing a telephone number listed on the
screen or by replacing an actor—to use for a dierent targeted audience, but does not substantially
change the advertisement’s script or theme, then the company is not required under Principle 8 to
submit the changed advertisement to FDA. However, where a company changes an advertisement so
that the benefit and/or risk information is presented in a dierent way, the company likely has made
a significant change, and the advertisement should be submitted to FDA. Other circumstances that
typically could trigger submission of DTC television advertisements under Principle 8 include:
(1) introduction of a new or never-before-advertised product; (2) new indications for existing products;
(3) significant new risk information; (4) new comparative claims or patient outcome claims; or (5) new
patient populations.
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Q9: Does Principle 8 necessarily require a company to submit the final version of a new DTC television
advertisement to FDA prior to releasing the advertisement for broadcast?
A9: No. The details of what will be submitted may be addressed in dialogue between companies and FDA.
Q10: Would additional dialogue between companies and the FDA be helpful as Principle 8 is
implemented?
A10: Yes. Additional dialogue should occur to maximize opportunities for FDA review of DTC television
advertising prior to release, consistent with this principle and the Agency’s priorities and resources.
Q11: Does Principle 9 require companies to mention in DTC television advertisements that the FDA’s
MedWatch number can be found in print advertisements or web sites?
A11: Principle 9 states that companies should direct viewers of DTC television advertisements to a print
advertisement containing FDA’s toll-free MedWatch telephone number and web site, and/or should
provide the company’s toll-free telephone number. Pursuant to statute, the FDA conducted a study
to determine if inclusion of FDA’s MedWatch information in DTC television advertisements would
detract from the presentation of risk information. While the FDA found that placement, duration, and
prominence of MedWatch information did not aect risk or benefit comprehension, the FDA has not
otherwise required MedWatch information to be presented in DTC television advertisements. Companies
abiding by PhRMA’s Guiding Principles should follow any guidance from FDA on including such
information when available.
Q12: Under Principles 3 and 12, does a company have to mention another medication that may also be
appropriate for treating the advertised condition?
A12: No. These Principles are intended to encourage companies to include in their advertisements
information about therapeutic options and appropriate steps patients could take (which may or may
not include other medicines), in consultation with health care professionals, to treat their disease or
condition. This is consistent with the pharmaceutical industry’s goal of helping patients achieve better
overall health.
Q13: Does Principle 10 require that all actors portraying health care professionals in DTC television and
print advertisements need to be disclosed in the advertisements?
A13: Actors who have a central role playing health care professionals in a DTC television or print advertising
campaign should be identified in the advertisements as actors. Actors who are shown as health care
professionals in the background in a DTC advertisement need not be disclosed.
Guiding Principles Direct to Consumer Advertisements About Prescription Medicines
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Q14: Is there only one right way to present risk information in advertisements?
A14: No. An advertisement will comply with Principle 14 if it presents information about the medicine’s risks
in a way that patients are reasonably likely to take in and understand this information. For television
advertisements, the visual and audio presentation of risk information should be similar in terms of
prominence and clarity to the visual and audio presentation of other information about the medicine.
Of course, even the most informative advertisements can’t provide information on all possible risks that
may relate to each individual patient. Therefore, the conversation between a patient and a health care
professional is critical to the patient’s understanding of whether a medicine is right for that individual
patient. DTC advertisements should motivate patients to ask their health care professionals for more
information about a medicine’s risks and benefits. These objectives can be achieved in a variety of
ways, and each company will exercise its judgment consistent with FDA requirements.
Q15: Principle 14 refers to the inclusion of relevant boxed warnings in DTC television and print
advertisements. Must DTC advertisements replicate boxed (or “black box”) warnings in their entirety?
A15: No. The FDA requires all DTC advertisements to present a brief summary relating to side eects,
contraindications, and eectiveness, which would be expected to include the substance of relevant
boxed warnings. However, the language in these warnings is often complex and technical, as they
typically are geared toward health care professionals. In order to ensure important risk information is
communicated in a manner that is readily understood, boxed warnings may be translated into language
more appropriate to consumers. Companies should work with the FDA in developing such consumer
appropriate translation of relevant boxed warnings.
Q16: Who will define how risk information can be presented with reasonably comparable prominence to
benefit information and “in a clear, conspicuous and neutral manner,” as stated in Principle 14?
A16: As this language is based on current laws and regulations enforced by the FDA, it is ultimately up to
the FDA to provide guidance on these standards. Companies should follow FDA’s guidance and should
work with the FDA to implement these standards appropriately.
Q17: What happens if a comment from the public about a company’s DTC advertisement conflicts with
recommendations or comments the company has received from FDA regarding the advertisement?
A17: The FDA has the authority to determine whether a particular advertisement is consistent with FDA
regulations. If FDA chooses to give recommendations or comments on a particular DTC advertisement
and the company follows those recommendations or comments, the company will be able to respond
to any complaint regarding that aspect of the DTC advertisement that it complies with the PhRMA
Principles by virtue of the fact that it followed FDA’s recommendations.
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Q18: Does Principle 15 suggest that all advertisements should be somber in tone and should not employ
lightness, humor or entertainment?
A18: No. Principle 15 recognizes that health conditions and medical treatments are serious issues for patients.
While humor or entertainment may not be appropriate in conveying all messages, they may be eective
tools for attracting public attention to a particular disease or treatment, reducing any stigma associated
with the condition, communicating educational messages about health conditions, and motivating
patients to discuss those conditions openly with their health care providers.
Q19: What criteria should be applied to determine whether a company has complied with Principle 16
and targeted its advertising to avoid audiences that are not age appropriate for the messages in the
advertisements?
A19: Advertisements containing content that may be inappropriate for children should be targeted to
programs or publications that are reasonably expected to draw an audience of approximately 90
percent adults (18 years or older). In determining where to place their advertisements, companies may
also consider whether the medicine being advertised addresses a public health concern. Companies will
be individually responsible for examining reliable, up-to-date audience composition data, to the extent
that information is available, to determine whether a particular program or publication is reasonably
likely to attract an audience that is age appropriate for a particular advertisement. In addition, a
medicine’s lack of a pediatric indication does not mean that the content of an advertisement for that
medicine is inappropriate for children.
Q20: How should companies evaluate whether particular advertisements have “content that may be
inappropriate for children” under Principle 16?
A20: In making this evaluation, companies should focus on whether the content— including text (visual or
audio), images and themes—in the advertisement, taken as a whole, is sexually explicit in nature such
that it is not suitable for children.
Q21: How should companies communicate in their DTC television advertisements where patients and
consumers can go to find the cost information referenced in Principle 19?
A21: Companies should provide clear instructions in their DTC television advertisements directing a patient
to where cost information can be obtained, as referenced in Principle 19. For example, if the Company
is providing information on a company-developed website, the Company could choose within its
television advertisements to provide a textual link or URL to the web page where such information
is available and clearly identify that cost information can be obtained at that web page. As another
example, a company could choose to include a voiceover mentioning a website and clearly identifying
that cost information can be obtained there.
Guiding Principles Direct to Consumer Advertisements About Prescription Medicines
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Q22: Where should companies make the information referenced in Principle 19 available?
A22: Each company should decide for itself the most eective way to communicate the information
referenced in Principle 19 to patients. For example, if a company uses a website to fulfill Principle 19,
such website may be the same website, including a separate tab or page on the website, to which the
Company refers patients for additional risk and benefit information about the product as per Principle
14. Additionally, such website could include a subpage or link to a separate website to provide
information regarding company resources that may help patients with the cost of their medicine per
Principle 18.
Q23: How should companies determine the specific details to be provided to patients under Principle 19?
A23: Each company should determine on an individual basis what is necessary to provide patients with
useful information about that company’s products under Principle 19.
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
950 F STREET, NW, WASHINGTON, DC 20004 | WWW.PHRMA.ORG
Revised October 2018
