THE FDA BAD AD PROGRAM AND PRESCRIPTION DRUG PROMOTION
The FDA Bad Ad Program and Prescription
Drug Promotion
Introduction
Welcome to the Food and Drug Administration’s, or FDA’s, course titled, “The FDA Bad Ad Program and
Prescription Drug Promotion.” During the next hour we will share information to help you make
thoughtful and critical consideration of the drug information you get through prescription drug
promotion. We’ll also talk about how you can spot prescription drug promotion that may be false or
misleading or raise other concerns and the important role that you can play in helping FDA ensure that
prescription drug advertising and promotion is truthful and not misleading.
Target Audience
The target audience for this course is health care professionals including physicians, physician assistants,
nurses, nurse practitioners, pharmacists, pharmacy technicians, and students.
Course Objectives
After completing the course, you will be able to:
• Identify the role that FDA’s Office of Prescription Drug Promotion, or OPDP, plays in regulating
prescription drug promotion and advertising
• Recognize persuasive techniques commonly used in advertising and promotion
• Describe the most common regulatory issues raised by prescription drug promotion
• Recognize potentially false or misleading prescription drug promotion
• Locate the Bad Ad contact information
• Translate knowledge into action and report potentially problematic prescription drug promotion
to OPDP
THE FDA BAD AD PROGRAM AND PRESCRIPTION DRUG PROMOTION
Course Navigation
This course features many useful navigation features. Each screen includes:
• Hyperlinks to the FDA Web site and the Center for Drug Evaluation and Research, or CDER, Web
page at the top left of the screen.
• A progress bar showing the current and total slide numbers for each module at the bottom of
the screen.
• The current module number and title at the top right of the screen.
There are two menu options, which can be expanded or collapsed, located at the top of the screen: the
Course Menu and Resources. The Course Menu tab accesses the Course Map, which lists all of the
modules in the course. The outline can be expanded or collapsed, and each heading is hyperlinked for
navigation.
Course Navigation
The Resources tab includes a link for Help, which displays instructions for using the course navigation
features. There are hyperlinks to the FDA/Drugs, CDERLearn, and CDER OPDP Web pages, as well as a
hyperlink to view FDA Compliance Examples in the form of Untitled and Warning Letters, some of which
were issued as a result of Bad Ad complaints. The Common Drug Promotion Issues link accesses a
document describing common regulatory issues regarding prescription drug promotion. Lastly, the
Resources tab includes an email link for submitting any question you may have regarding this course to
the FDA/CDER Office of Communication’s Division of Drug Information, or DDI, and a Bad Ad email link
and phone number for reporting potentially false or misleading or otherwise concerning promotional
activities to the Bad Ad program office.
Course Navigation
The toolbar at the bottom of the screen features common navigation buttons, including:
• The Exit button, which closes the current module and pulls up the course map.
• The Pause/Play button, which halts and resumes playback.
• The CC button, which accesses closed captions.
• The Home button, which returns the user to the title page.
• The Back button, which returns the user to the previous page.
• The Next button, which advances playback to the next page.
Please note that all videos have their own navigation controls located at the bottom of each video
window. These controls should be used to manage video playback and closed captioning.
The Bad Ad Program
It is important to note that Williams and Williams Pharmaceuticals is a fictional company and Declesau is
a fictional drug. They were designed for this training program and are used for educational purposes
only.
THE FDA BAD AD PROGRAM AND PRESCRIPTION DRUG PROMOTION
The Bad Ad Program
Pharmaceutical promotion is everywhere, from journal ads to webpages to social media to face-to-face
sales calls to TV ads. When you think about the number of messages you are exposed to per day, per
week, per year; it’s staggering.
There are approximately 70,000 pharmaceutical sales reps working in the field today, making 8-10 calls
per day, promoting 1 to 3 products per call. This means that anywhere from 145 million to 546 million
promotional presentations are given per year. Add to that over 100,000 unique pieces of prescription
drug promotional materials, such as journal ads, sales aids, and emails that are distributed to consumers
and health care professionals, and the amount of messages aimed at informing and influencing you can
be overwhelming.
Pharmaceutical companies can play an important role in disseminating information about prescription
drugs, such as information about the availability of newly approved drugs and updated risk information
about a particular drug.
Today we’ll help you recognize persuasive techniques that are used in all kinds of advertising and
promotion to help you be a better informed, more critical consumer of information. And we’ll discuss
how to analyze drug promotional materials so that you can discern false or misleading information from
information that may be useful in your practice.
FDA Timeline
Before the 20th century, there were few laws regulating the content and sale of domestically produced
drugs. Some state laws were drafted against unethical sales practices, but the growing pharmaceutical
industry was largely unmonitored and unregulated. A wide range of medicines, tonics, elixirs, and fluid
extracts were developed and marketed with extravagant claims of their curative powers. Some
concoctions posed little health risk but were ineffective. Still, others posed a serious health risk to
consumers.
In 1905, Collier’s Weekly ran a series of 11 articles by Samuel Hopkins Adams entitled “The Great
American Fraud,” denouncing the patent-medicine industry for deceiving the public and hawking
poisonous potions as cure-alls. Increasing public sentiment toward increased regulation in the food and
drug industries led to President Roosevelt signing the Pure Food and Drugs Act of 1906. This law, among
other things, prohibited the manufacture, sale, or transportation of poisonous patent medicines.
The FDA, however, still had serious challenges in its efforts to protect the public health. The 1906 Act
was not stringent enough to prevent the sale of harmful products such as Banbar, a worthless “cure” for
diabetes; or Radithor, a radium-containing tonic that sentenced users to a slow and painful death. Under
the 1906 law, these products were still legal.
In 1937, tragedy struck. Over 100 people, many of them children, died following the treatment with
Elixir Sulfanilamide, an untested formulation of Sulfanilamide that was highly toxic. The public outcry
not only reshaped the drug provisions of a new law to prevent such an event from happening again, it
helped push the bill through Congress. On June 25, 1938, President Franklin D. Roosevelt signed the
Federal Food, Drug, and Cosmetic Act, which mandated that a drug be proven safe before it could be
marketed and granted the FDA greater powers to regulate the industry.
THE FDA BAD AD PROGRAM AND PRESCRIPTION DRUG PROMOTION
In the early 1960s, a medical disaster abroad drew renewed public attention to the need for strong
United States government oversight of drugs. In this case, Thalidomide, a sedative used for morning
sickness, but never approved for use in the United States, caused tragic birth defects in thousands of
newborns in other countries. Attention to the Thalidomide tragedy helped lead to passage of the 1962
Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act, or FD&C Act, signed by
President Kennedy. The 1962 Amendments mandated that drugs be proven effective as well as safe
before they could be marketed, and gave the FDA tighter controls over drug trials. The 1962
amendments also gave FDA the authority to regulate prescription drug advertising, in addition to its
authority over prescription drug labeling, which includes the package insert or PI. The prescription drug
advertising regulations established as a result of the 1962 Amendments are detailed in the Code of
Federal Regulations, section 202.1.
It is in part because of medical disasters like these that the FDA is tasked with assuring that all
prescription and over-the-counter drugs are safe and effective.
In addition, in 1965, to ensure that the promotional practices of the past—wild, extravagant claims that
provided false or misleading information—were not continued, FDA established the Medical Advertising
Branch in the Division of Medical Review to monitor prescription drug advertising and promotion.
Now known as the Office of Prescription Drug Promotion, or OPDP, its mission is simple: to protect and
promote public health by assuring prescription drug information is truthful, balanced, and accurately
communicated. This is accomplished through a comprehensive surveillance, enforcement, and
education program, and by fostering better communication of prescription drug labeling and its related
promotional information to both health care professionals and consumers. While the promotion and
advertising of prescription drugs is much improved from years past, there are still some instances of
false or misleading promotion, or promotion that raises other regulatory concerns, so there is still work
to be done.
The Bad Ad Program grew out of the office’s mission. Specifically, Bad Ad is the FDA's educational
outreach program designed to educate the health care professionals to recognize potentially false or
misleading prescription drug promotion and provide them with an easy way to report it to the agency.
Hi, I am Janet Woodcock, the Director of the Center for Drug Evaluation and Research, or CDER, at the
Food and Drug Administration. Our mission at CDER is to ensure that the medicines you use, or will use,
to treat your patients have been proven safe and effective. Another important part of our mission is
ensuring that the information communicated to you by drug companies about these drugs is accurate
and not misleading. After all, making treatment decisions based on the best available information
benefits everyone. One way we accomplish this mission is through outreach programs like Bad Ad. By
educating members of our health care community about misleading drug promotion and advertising and
how to report it, we hope to improve the overall quality of information available to you about
prescription drugs. Although the days of Banbar and Radithor are a distant memory, constant vigilance
over the promotional claims of prescription drugs remains important for the safe and effective use of
medicines. We hope this course provides you with a basic knowledge of the regulation of drug
promotion and how to play a part, if you choose, in increasing the quality of prescription drug
information available to you, your colleagues, and your patients.
THE FDA BAD AD PROGRAM AND PRESCRIPTION DRUG PROMOTION
Module 1: The FDA, Prescription Drug Promotion, And You – The Bad Ad
Program
Bad Ad – What Is It?
The Bad Ad Program was created to serve as an awareness and outreach program to educate health
care professionals about potentially false or misleading drug promotion and provide them an easy
method to report it.
Bad Ad – Why Was It Created?
The Bad Ad Program was created to increase the effectiveness of FDA’s Office of Prescription Drug
Promotion, or OPDP’s, surveillance program. OPDP’s traditional regulatory activities primarily relied on
reviewing promotional materials submitted to them by pharmaceutical companies; investigating
complaints from industry, health care professionals, and consumers; and conducting risk-based field
surveillance. While highly effective, OPDP was not able to observe drug promotion in settings such as
physician offices, local dinner programs, or speaker presentations.
Bad Ad – Program Goals
Thus, the Bad Ad Program was established to raise awareness of the most common regulatory issues in
health care professional-directed prescription drug promotion and serve as a way in which health care
professionals can report suspected false or misleading drug promotion to the FDA. In this way FDA, in
collaboration with concerned health care professionals, can ensure that prescription drug promotion is
truthful and not misleading, wherever it may occur.
Bad Ad – How You Can Help
In order to help you recognize false or misleading promotion, we will discuss some of the most common
issues a little later on in the course. The next step is to know how to report a promotional activity of
concern. FDA has simplified the reporting process. All you need to do is send an email to
badad@FDA.gov or call 855-RX-BADAD to submit a complaint. It’s that easy. But before we get into that,
we will first discuss some of the common persuasive techniques used in prescription drug promotion. It
is important to note that these principles are not regulated by FDA, nor are these principles illegal or
unethical. They are simply tools that any company can use to market and sell their products.
Module 2: The Science of Influence
The Science of Influence
Hi, I’m Dr. Linda Demaine. As you have studied the science of medicine, social psychologists including
myself have studied the science of influence—how other people convince us to hold certain beliefs and
opinions, and to act in certain ways.
If you’ve ever left a sales pitch with a new product and wondered: “Why did I buy that?” the science of
influence can help solve the mystery. Certain elements of the sales context and certain things
salespeople say can convince us to purchase products that we would otherwise refuse.
THE FDA BAD AD PROGRAM AND PRESCRIPTION DRUG PROMOTION
Over the next few minutes, I’ll briefly describe some principles of persuasion that are relevant to
marketing. Afterward, we’ll go through a few scenarios that illustrate how companies may use these
principles of influence to help sell their products.
So let’s explore the science of influence.
While many factors can influence our behavior, I will focus on six well-documented principles of
influence.
Dr. Robert Cialdini identified these six principles of influence, and researchers have tested these
principles in many different contexts, where they've proven to be quite effective in shaping our
behavior.
The first principle is SCARCITY. People want those things that are in limited supply. Things that are scarce
are viewed as more attractive and more valuable - and we're willing to pay more and exert greater
effort to obtain them. This principle underlies the value placed on rare versus common collectibles, for
example. It's that difficult-to-find stamp, coin, or book that makes the collection, not the items that are
more readily available. The scarcity principle also explains why limited-time offers are more enticing
than the items for purchase inherently warrant. When the offer expires, the items may be gone for
good, and we therefore desire to acquire them while we can.
The second principle is SOCIAL PROOF. We follow the lead of similar others - we look for evidence of
what others who are similar to us are doing in a situation and do the same thing. After all, if other
people are behaving in a particular way, it’s probably the right way to behave. The social proof principle
underlies, for example, our willingness to buy best-seller books or to try popular restaurants. Other
persons consider these things worthwhile, and we're therefore inclined to experience them as well.
Dr. Cialdini's third principle of social influence is COMMITMENT AND CONSISTENCY. People want to be
consistent with what they have already said or done. We must have had good reason to make those
statements or do those things initially; the logic goes, so it makes sense to act consistently with them.
This is why, for example, signing a petition in support of a political candidate or making a testimonial
about a product causes us to subsequently be more willing to support that candidate or purchase that
product. We've committed ourselves with that seemingly innocuous first step, and we're therefore more
likely to agree to greater investments of our time and money that are consistent with our initial
commitment.
The fourth principle is RECIPROCITY. People would be much less willing to help out one another if they
thought that their good deeds would go unrewarded. And helping behavior keeps society strong. So as
part of our socialization, we've been taught to give back to those who give to us. We are more likely to
purchase a product, for example, after accepting a sample of it or accepting a small gift or favor - a
bottle of water, the use of a telephone - from a salesperson. That person does something for us, and we
feel obligated to do something for them in return - to buy what they are selling.
The fifth principle of social influence is AUTHORITY. People are more likely to take advice from those
who are experts on a subject. We're more likely to believe the advice of an electrician about how to wire
a lamp, for example, than we are to rely on the opinions of our friends who possess no extraordinary
knowledge on the topic. Persons with expertise are more likely to accurately assess and respond to
situations in their area of expertise, and it generally serves us well to follow them.
THE FDA BAD AD PROGRAM AND PRESCRIPTION DRUG PROMOTION
The last of Dr. Cialdini's principles is LIKING. People more often comply with requests made by those
they like. Regardless of why we like someone - they're similar to us, they're physically attractive - people
we like have a greater ability to influence our decisions and behaviors than do people for whom we have
lower positive regard. Now you are familiar with the principles of influence. Later you will see how they
apply to real life scenarios.
Module 3: FDA Oversight of Prescription Drug Promotion
Pharmaceutical Industry Drug Promotion – Prescription Drug Promotion
Pharmaceutical promotion is a multi-billion dollar industry – in 2017, pharmaceutical companies spent
over 24 billion dollars promoting their drugs to health care professionals and consumers. As I am sure
you are aware, the most visible and pervasive form of prescription drug promotion is direct-to-
consumer promotion, such as television commercials, print ads, and internet-based promotion. These
direct-to-consumer promotional communications, however, represent only a small percentage of the
total prescription drug promotion budget.
Pharmaceutical Industry Drug Promotion – Prescription Drug Promotion
Spending by pharmaceutical companies to market prescription drugs directly to healthcare professionals
actually outpaces spending on direct-to-consumer promotion by more than 3-to-1. In 2017 alone, the
pharmaceutical industry spent over 18.5 billion dollars on journal ads, visual aids, web pages, emails,
and various other promotions aimed specifically at healthcare professionals. Using these materials,
pharmaceutical companies reach out to healthcare professionals in medical offices, hospitals,
pharmacies, medical conferences, and industry-sponsored events.
Regulating Prescription Drug Promotion and Advertising – FDA Authority
Under the Federal Food Drug and Cosmetic Act, or FD&C Act, Congress gave FDA authority over
prescription drug advertising and other promotion – both directly, through statutory provisions
specifically addressing prescription drug advertising and labeling, and indirectly, through provisions
addressing “intended use” of marketed drugs, and the requirements for FDA approval. Particular
requirements apply to prescription drug promotion. Among these, prescription drug promotion must be
consistent with FDA-required labeling, which includes the Package Insert. Furthermore, prescription
drug promotion must present only truthful and non-misleading information that is appropriately
supported. Prescription drug promotion must also present known risks associated with the drug along
with the benefits.
Oversight of Prescription Drug Promotion
Prescription drug promotion can happen in many different venues and through various media. It may be
carried out by a pharmaceutical company directly, or by others acting on their behalf. For example,
prescription drug promotion may take the form of TV and radio advertisements, one-on-one
interactions between sales representatives and healthcare professionals, speaker programs where a
paid speaker is presenting on behalf of a pharmaceutical company, internet-based promotion, and many
different kinds of written or printed materials.
THE FDA BAD AD PROGRAM AND PRESCRIPTION DRUG PROMOTION
FDA’s Office of Prescription Drug Promotion monitors prescription drug promotion, regardless of the
form, to ensure compliance with applicable legal requirements.
Oversight of Prescription Drug Promotion
It is important to note, however, that FDA’s Office of Prescription Drug Promotion does not oversee the
advertising and promotion of over-the-counter medications, dietary supplements, medical devices,
compounded drugs, or prescription or over-the-counter drugs for animals. Promotion and advertising of
these products are regulated by other groups in FDA or by the Federal Trade Commission.
Module 4: Common Drug Promotion Issues
Omission of Risk
Twyla Thompson, PharmD, Deputy Director, Office of Prescription Drug Promotion: Promotional
materials that include claims regarding a drug's efficacy must also include information regarding the
important risks associated with the drug that are included in the drug's Package Insert, including Black
Box Warnings, which are the most serious warning a drug can have; contraindications; and warnings and
precautions. So what does this mean for you? Well, let's say, for example, you are looking over a sales
aid for a drug that you know has a Black Box Warning. This sales aid has pages and pages of information
regarding the efficacy of the drug - how great the drug works - but, you notice that the Black Box
Warning isn't presented anywhere in the sales aid. The lack of this important risk information from a
sales aid that has numerous claims regarding the efficacy of the drug would be misleading - an omission
of risk. Before we move on, it’s important to note that this regulation regarding omission of risk applies
to all prescription drugs, not just those with Black Box Warnings.
Minimization of Risk
CDR, Melinda McLawhorn, PharmD, MPH, BCPS, RAC, Team Leader, Office of Prescription Drug
Promotion: When you are looking over a promotional piece, risk information must be presented with
prominence and readability reasonably comparable to the presentation of efficacy information. Many
factors can impact prominence and readability - for example, the style, size, and color of the font, layout
of the piece, and the use of white space.
You can think of it like this - you are looking over a journal ad that presents efficacy claims in large, bold
font with colorful graphics - the information really pops off the page. But the risk information, however,
is buried all the way on the bottom of the page in tiny font with no headings or other signals to alert you
to the presence of this important information. This format, in which the risk information is not
presented with comparable prominence to the efficacy claims, minimizes the risks associated with the
drug.
Overstating the Effectiveness
Christine Corser, PharmD, RAC, Health Science Policy Analyst, Office of Prescription Drug Promotion:
Promotional materials would be considered false or misleading if, for example, they, one, overstate or
exaggerate the effectiveness of a drug; two, make claims regarding the efficacy of the drug that aren't
appropriately supported; or three, misrepresent data from clinical studies.
THE FDA BAD AD PROGRAM AND PRESCRIPTION DRUG PROMOTION
For example, let's say, during a sales call, a sales representative is promoting an antibiotic that we'll call
DECLESAU. The sales representative shows you a flyer which contains the claim, "DECLESAU works in as
little as 3 days." However, according to the Package Insert, the primary endpoint in the clinical trials
used to support the approval of this drug was relief after 10 days, and there is no available data or
evidence to support a shorter duration of treatment. Therefore, this claim misleadingly suggests that the
drug works faster than what has been demonstrated.
Misbranding of an Investigational Drug
Nima Ossareh, PharmD, RAC, Regulatory Review Officer, Office of Prescription Drug Promotion: Under
FDA regulations, if a sponsor represents in a promotional context that an investigational new drug is
safe and effective for the uses under investigation or otherwise promotes the drug, when that drug has
not been approved as a drug for any use, the investigational drug would be misbranded. This type of
promotion may create a misleading impression regarding the usefulness and approval status of this
product.
For example, let’s say DECLESAU is an investigational drug that is being studied for uses in treating
complicated skin and skin structure infections and uncomplicated UTIs. DECLESAU has not been
approved by the FDA for any use. However, a detail aid for the drug claims that DECLESAU is “an
innovative treatment for complicated skin and skin structure infections and uncomplicated UTIs” and
that “DECLESAU has demonstrated efficacy across a broad range of patients with a low rate of side
effects.” These conclusory claims suggest, in a promotional context, that DECLESAU is safe and effective
for treating complicated skin and skin structure infections and uncomplicated UTIs when it has not been
approved as safe and effective for any use. Therefore, DECLESAU would be misbranded. The conclusions
made in these claims may create a misleading impression regarding the usefulness and approval status
of DECLESAU.
Misleading Drug Comparisons
Brian Tran, PharmD, MBA, Team Leader, Office of Prescription Drug Promotion: Claims or presentations
in promotional materials that suggest that a drug is safer or more effective than another drug would be
considered false or misleading if they are not appropriately supported. For example, you are attending a
symposium and you stop by the promotional booth for DECLESAU. A bar chart on a convention panel at
the booth compares study results from DECLESAU’s Package Insert and study results from its main
competitor’s Package Insert and includes a claim stating that DECLESAU showed improvement in
significantly more patients than its competitor. This comparison would be misleading because
comparing the response rates for two different drugs in two different studies does not support a
conclusion that one drug is safer or more effective than another because, for example, these studies
may have been conducted in different patient populations or using different clinical study designs and
methodologies.
Module 5: Prescription Drug Promotion: Real-Life Scenarios
Prescription Drug Promotion Scenarios
So, you’ve learned about persuasive techniques that marketers of all kinds can use to influence
behavior. And you’ve learned about various common regulatory issues in prescription drug promotion.
THE FDA BAD AD PROGRAM AND PRESCRIPTION DRUG PROMOTION
Now, let’s put your knowledge to the test using real-world scenarios. Throughout a Medical Park,
healthcare professionals are coming face-to-face with drug advertising and promotion. Using the
information that we just presented, can you correctly identify the potential regulatory issues in each
scenario? Click on any one of the five locations, which include the emergency department, a Grand
Rounds presentation, a break room, a pharmacy, and a doctor’s office, to view these encounters. Make
sure that you check out the Package Insert for the drug being promoted – you will find a link to this
useful resource in the newspaper dispenser. Remember, the Package Insert is a valuable resource for
important information about a prescription drug. Immediately following the video, you will be asked to
choose the best answer to identify a common potential regulatory concern illustrated by the video. In
addition, Dr. Demaine will point out the use of one or more principles of persuasion. Remember, if you
experience anything similar to these scenarios, please report the incident to FDA’s Office of Prescription
Drug Promotion. FDA will evaluate each case to determine whether to investigate further or whether
there appears to be evidence that the law has been violated. Alerting FDA about prescription drug
promotion that you think raises concerns will help increase the quality of prescription drug promotion
available to you, your colleagues, and your patients. Please note that the following scenarios are
designed to highlight a specific regulatory issue. However, this issue may not be the only one presented
in the scenario.
Doctor’s Office
Sales Representative: Dr. Smith!
Dr. Smith: Oh hey, Jane. Hi, how are you doing?
Sales Representative: I’m good, how are you?
Dr. Smith: Good, good.
Sales Representative: Good to see you.
Dr. Smith: Nice to see you.
Sales Representative: How are the kids?
Dr. Smith: The kids are great. Sara is loving the new school and Nick was made captain of his volleyball
team.
Sales Representative: Oh, you’re kidding! That’s wonderful! Congratulations.
Dr. Smith: Thank you, thank you.
Sales Representative: So, I just wanted to stop by today to give you some new and exciting information
regarding DECLESAU. DECLESAU is now indicated for treatment of skin structure infections. As you
know, DECLESAU is associated tendinitis and tendon ruptures, and exacerbation of myasthenia gravis,
but this is more of a class effect and not really something to worry about. Personally I call on over 100
doctors, they prescribe DECLESAU all the time and none of them have seen these effects. I’m going to
leave you with this brochure. It explains everything in more detail. Take a look at it. If you have any
questions at all, give me a call.
Dr. Smith: Alright. Sounds good. Take care of yourself.
THE FDA BAD AD PROGRAM AND PRESCRIPTION DRUG PROMOTION
Sales Representative: Good to run into you today.
Dr. Smith: You too.
What did you just witness?
What did you just witness? A: Omitting Risk, B: Minimization of Risk, C: Overstating Effectiveness, D:
Misbranding an Investigational Drug, or E: Misleading Drug Comparisons
Minimization of Risk
CDR. Melinda McLawhorn, PharmD, MPH, BCPS, Team Leader, Office of Prescription Drug Promotion:
You just witnessed a drug representative minimizing the known risks of a prescription drug.
Specifically, the sales representative states that DECLESAU has Black Box Warning for tendinitis and
tendon ruptures, and exacerbation of myasthenia gravis, but then goes on to minimize these risks by
stating that it is more of a class effect and not really something to worry about. He even indicates that
he calls on over 100 doctors and that none of them have seen these reported effects.
Dr. Linda Demaine J.D., PH.D: By the way, did you notice the use of the persuasive principles of Social
Proof and Liking?
In this scenario, when the sales representative says to Dr. Smith that none of the 100 doctors he
markets to have any concerns about the conditions described in the Black Box warnings - and thereby
implies that Dr. Smith need not be concerned with them either -- he is using the principle of social proof.
Remember, people are likely to follow the lead of similar others. Additionally, in this interaction, it is
evident that the sales representative and Dr. Smith have a good rapport, consistent with the principal of
liking. People whom we like are more able to influence our decisions and behaviors.
Grand Rounds
Sales Representative: Hi, and thank you all for coming to our promotional speaker program. Today we
have the honor of having Dr. Kovac speak with us. As I am sure you all know, Dr. Kovac is one of the
foremost experts on complicated skin and skin structure infections. He is here today to discuss an
ongoing study with an investigational drug. And without further ado, Dr. Kovac.
(Dr. Kovac steps to the podium.)
Dr. Kovac: Good afternoon. Hi. I am here today on behalf of Williams & Williams Pharmaceutical to
discuss a study for one of the company’s pipeline products DECLESAU. As I’m sure you know, Williams &
Williams is sponsoring a study of DECLESAU in use in patients suffering from complicated skin and skin
structure infections. The study compares patients receiving DECLESAU with patients receiving traditional
therapy. DECLESAU has proven to offer significant improvement when compared to the traditional
therapy and with a highly effective cure rate, no added side effects, it is truly the next generation
treatment option for patients with complicated skin and skin structure infections.
What did you just witness?
What did you just witness? A: Omitting Risk, B: Minimization of Risk, C: Overstating Effectiveness, D:
Misbranding an Investigational Drug, or E: Misleading Drug Comparisons
THE FDA BAD AD PROGRAM AND PRESCRIPTION DRUG PROMOTION
Misbranding an Investigational Drug
Nima Ossareh, PharmD, RAC, Regulatory Review Officer, Office of Prescription Drug Promotion: In this
last scenario, you witnessed a speaker, presenting on behalf of the company, suggest in a promotional
context that an investigational drug is safe and effective for the use under investigation when the drug
has not been approved for any use. The speaker, who is appearing as a representative of the drug's
manufacturer, stated that DECLESAU has been proven to offer significant improvement compared to
traditional therapy with a highly effective cure rate and no increase in side effects. He also stated that
DECLESAU is the next generation treatment option for complicated skin and skin structure infections.
However, DECLESAU, an investigational drug as noted by the sales representative, has not been
approved as safe and effective for any use. The conclusions made in these claims may create a
misleading impression regarding the usefulness and approval status of DECLESAU. Thus, the speaker’s
statements may prompt further investigation and could be presented as a piece of evidence in a
misbranding case.
Dr. Linda Demaine J.D., PH.D.: Did you notice the use of the persuasive principle of Authority? As
indicated in the scenario, Dr. Kovac is considered an authority in the field of infectious diseases. And,
according to the authority principle, people are more likely to take advice from others who are
considered experts in a subject, rather than someone who has little to no experience.
Sponsored Lunch
Sales Representative: So if you guys want to take your seats, we’re going to start in just a second. Excuse
me, excuse me. Hi. I hope that you all are enjoying your lunch today provided by Williams & Williams
Pharmaceuticals. If you don’t mind, I would just like to take just a couple minutes to talk to you about a
new indication for DECLESAU. DECLESAU is now approved for the treatment of skin and skin structure
infections caused by methicillin-susceptible S. Aureus, E. Coli, K. pneumoniae, or E. cloacae.
(The desktop placard reads: “The success rate for treatment of skin infection was incredibly high - 91
percent”)
Sales Representative: Clinical studies performed in patients with skin infections demonstrated a 91
percent success rate. Now, DECLESAU is associated with black box warnings for tendonitis…
What did you just witness?
What did you just witness? A: Omitting Risk, B: Minimization of Risk, C: Overstating Effectiveness, D:
Misbranding an Investigational Drug, or E: Misleading Drug Comparisons
Overstating the Effectiveness
LT. Christine Corser, PharmD, Health Science Policy Analyst, Office of Prescription Drug Promotion: This
scenario highlighted a claim from a promotional piece that overstated the effectiveness of a prescription
drug. Specifically, the promotional placard on the table states that DECLESAU has a success rate of 91
percent. However, the Package Insert states that DECLESAU has a success rate of 81 percent. Inflating
the success rate by 10 percent overstates the efficacy of DECLESAU.
Dr. Linda Demaine J.D., PH.D.: Did you notice the use of the persuasive principle of Reciprocity?
THE FDA BAD AD PROGRAM AND PRESCRIPTION DRUG PROMOTION
In this scenario, the sales representative provided a free lunch. Gifts such as these cause us to be more
likely to say "yes" to a request made by the person or company that provides them.
Break Room
PA Announcement: Attention. The memorial blood drive now taking place in room 237-B until 4pm
today.
(Doctor grabs a medical journal from a rack of journals, and sits down to eat/drink and read. She flips
through the journal and stops on a particular journal advertisement. The advertisement contains the
following claims, “DECLESAU: Now approved for the treatment of skin infections! #1 Prescribed
Antibiotic In Its Class.” The advertisement includes indications and common adverse reactions.)
PA Announcement: Paging Dr. Smith to trauma room 3. Dr. Smith to trauma room 3.
(Doctor tears out the journal ad, puts it in her pocket, and walks out the door.)
What did you just witness?
What did you just witness? A: Omitting Risk, B: Minimization of Risk, C: Overstating Effectiveness, D:
Misbranding an Investigational Drug, or E: Misleading Drug Comparisons
Omitting Risk
Twyla Thompson, PharmD, Deputy Director, Office of Prescription Drug Promotion: The advertisement
in the journal ad omits known risks of a prescription drug. The colorful, engaging print advertisement
promotes the benefits of DECLESAU and mentions certain adverse reactions, but fails to include
important information, including the Black Box Warnings, Contraindications, and Warnings and
Precautions, regarding the risks associated with the drug.
Dr. Linda Demaine J.D., PH.D.: Did you notice the principle of Social Proof in the journal ad? Remember,
social proof can be described as the following: we are more inclined to do what others similar to us are
doing in a certain situation. In this journal ad, the claim, "#1 Prescribed Antibiotic in Its Class,"
communicates that many of this doctor's colleagues choose DECLESAU over other antibiotics.
Retail Pharmacy
(Sales Representative enters the pharmacy and walks up to window.)
Sales Representative: Hello. May I please speak to the Pharmacist on duty?
Pharmacy Tech: Of course, I will go and get her.
Sales Representative: Thank you.
(The pharmacy tech goes back into the pharmacy to get the pharmacist.)
Pharmacy Tech: Excuse me, doctor. There is someone here to see you.
Pharmacist: Be right there.
(The pharmacist finishes up and goes to the window.)
THE FDA BAD AD PROGRAM AND PRESCRIPTION DRUG PROMOTION
Pharmacist: Hello.
Sales Representative: Hi, how are you?
Pharmacist: Good, thanks. And you?
Sales Representative: I am great. Thank you. My name is Jane Crawford, I’m from Williams & Williams
Pharmaceuticals.
Pharmacist: What can I do for you?
Sales Representative: Have you heard that DECLESAU is now indicated for the treatment of certain skin
infections?
Pharmacist: I remember reading something about that. But there are already several fluoroquinolones
on the market that are also used to treat skin infections, some even generic. I keep the ones I usually get
orders for stocked on my shelves, but not the newer, pricier ones.
Sales Representative: It’s true some older fluoroquinolones have generics and are cheaper. But
DECLESAU has a much higher success rate in treating skin infections than the ones you stock on your
shelf. As you can see by comparing the Package Insert for DECLESAU with the Package Insert for our
biggest competitor, the efficacy rates in our clinical trials were much higher. That means doctors are
going to prescribe DECLESAU over the other fluoroquinolones. Since patients can’t really wait for their
antibiotic to be delivered, you’ll lose your customers to the pharmacy across the street that has
DECLESAU in stock. So, can I count on you to stock DECLESAU?
Pharmacist: Yes, you make a good point. I will order some soon.
Sales Representative: Now, remember, DECLESAU is associated with boxed warnings for tendonitis…
What did you just witness?
What did you just witness? A: Omitting Risk, B: Minimization of Risk, C: Overstating Effectiveness, D:
Misbranding an Investigational Drug, or E: Misleading Drug Comparisons
Misleading Drug Comparisons
Brian Tran, PharmD, MBA, Team Leader, Office of Prescription Drug Promotion: You just witnessed a
misleading drug comparison - specifically, an unsubstantiated claim of superiority about a prescription
drug. In this scenario, the drug rep claims that DECLESAU has a much higher success rate in treating skin
infections than other fluoroquinolones on the market based solely on a comparison of the efficacy rates
in the Package Insert for DECLESAU and the Package Insert for its biggest competitor. This Package Insert
to Package Insert comparison is not enough to demonstrate DECLESAU’s superiority over other
fluoroquinolones, and the rep did not provide any other evidence, such as results from head-to-head
studies comparing DECLESAU to other fluoroquinolones.
Dr. Linda Demaine J.D., PH.D.: By the way, did you notice the use of the persuasive principles of Scarcity
and Commitment and Consistency? Recall that people want things that are in limited supply, and
according to the sales rep, the pharmacist will likely miss out on the opportunity to stock DECLESAU
unless he places an order for it soon. In addition, the sales representative, in asking if he could count on
THE FDA BAD AD PROGRAM AND PRESCRIPTION DRUG PROMOTION
the pharmacist to stock DECLESAU, and gaining the pharmacist’s commitment, used the principle of
commitment and consistency. As I indicated earlier, people generally act consistently with their previous
statements or actions.
Module 6: Reporting Potential Drug Promotion Issues
Submitting a Complaint
So why should you tell FDA when you spot a potential regulatory issue with a prescription drug
promotion? Well, in submitting a complaint to the Bad Ad Program, you can help protect public health
by ensuring that the prescription drug information that both health care professionals and their patients
use to help make treatment decisions is truthful and non-misleading.
Submitting a Complaint
Remember, submitting a complaint is easy. All you need to do is send an email to badad@FDA.gov, or
call 855-RX-BADAD, describing the promotional activity of concern. We’ll handle the rest. It’s that
simple.
Information to Include
Whether you call or submit an email, helpful information to include in the complaint is your name; the
name of the drug; the name of the pharmaceutical company and/or representative involved, if
applicable; day/time/place of the occurrence; and a brief description of the promotional activity,
including the aspects that particularly concern you. You can even submit your complaint anonymously;
however, complaints accompanied by names and contact information are helpful in cases where the
FDA needs to follow up for more information.
OPDP Compliance & Enforcement
Once a complaint is submitted, the information you provide will be given to the Regulatory Review
Officer in FDA’s Office of Prescription Drug Promotion who is responsible for this class of drugs. It is
important to note that all complaints are carefully reviewed. Now, this process does take time because
FDA must be thorough in its investigation.
OPDP Compliance & Enforcement
During the investigation, the reviewer will evaluate each complaint and determine if it may serve as the
basis for a potential compliance action or as valuable information for our ongoing surveillance activities.
While every report of a possible regulatory issue serves to contribute to OPDP’s surveillance activities,
they will not all serve as the basis for compliance actions.
OPDP Compliance & Enforcement
When a Bad Ad complaint has been thoroughly investigated and FDA’s Office of Prescription Drug
Promotion believes the evidence shows that a legal requirement has been violated, FDA will take
appropriate steps to address the promotion and ensure that the company complies with the law. FDA’s
compliance tools include issuing Untitled or Warning Letters.
THE FDA BAD AD PROGRAM AND PRESCRIPTION DRUG PROMOTION
OPDP Compliance & Enforcement
An Untitled letter notifies the company of the alleged violation and requests that they immediately stop
misbranding their products by ceasing dissemination of all claims and presentations that are false or
misleading, including all materials that would give rise to the same or similar violations as those
identified in the letter.
OPDP Compliance & Enforcement
A Warning Letter also notifies the company of the alleged violation and requests that they perform the
same actions as requested in an Untitled Letter, with the additional step of requesting that they correct
the message in the promotional material by distributing new material that acknowledges the violation
and provides truthful, balanced, and accurate information that is otherwise not misleading.
OPDP Compliance & Enforcement – FDA Actions
In addition, FDA, together with the Department of Justice, can bring enforcement actions in court, which
may result in injunctions, consent decrees, product seizure, civil and criminal monetary penalties,
and/or criminal prosecution. Reports sent to the Bad Ad program may also be used to help the
Department of Justice with ongoing investigations into possible misbranding of prescription drugs.
OPDP Compliance & Enforcement – FDA Compliance Activities
As of 2018, the Bad Ad Program has received over 1500 reports of potentially false or misleading
promotion, all of which have been thoroughly reviewed and investigated. In those cases where the
appropriate evidence and standards were met and documentation was available, OPDP took action.
For example, the Diclegis Warning Letter resulted, in part, from several complaints to the Bad Ad
program regarding a social media post by Kim Kardashian which presented various efficacy claims for
Diclegis but failed to communicate any risk information or convey important limitations of use regarding
the drug. In light of the potentially serious adverse public health impact of the violations, OPDP acted to
prevent the misleading post from being more broadly disseminated by issuing a Warning Letter which
subsequently resulted in the sponsor issuing a new post to correct the misleading messages.
The Afrezza Warning Letter was also based in part on a Bad Ad complaint regarding posts on the Afrezza
Facebook page. Specifically, one of the posts on the page suggested that there were no safety concerns
associated with the use of the drug. This was especially concerning from a public health perspective
because Afrezza is a drug with multiple serious, potentially life-threatening risks, including a Boxed
Warning. As a result, OPDP took action by issuing a Warning letter.
The Fycompa Untitled Letter resulted from a Bad Ad complaint regarding statements made by a sales
representative to healthcare professionals during a lunch presentation. These statements misleadingly
suggested that Fycompa was safe and effective for uses for which it was not approved, and for which its
FDA-required labeling, which includes the Package Insert, did not provide adequate directions for use.
This was especially concerning given the vulnerable pediatric population involved and the serious and
life-threatening health risks associated with Fycompa.
THE FDA BAD AD PROGRAM AND PRESCRIPTION DRUG PROMOTION
These are just a few examples of some compliance actions that resulted from complaints submitted to
the Bad Ad Program. For links to these and other examples of OPDP Warning Letter and Untitled Letters
stemming from Bad Ad complaints, please click on the link provided under the Resources menu.
Module 7: Conclusion
Conclusion
FDA seeks to protect and promote the public health through its regulatory activities. FDA’s Office of
Prescription Drug Promotion supports this mission by assuring that prescription drug promotion is
truthful, balanced, and accurately communicated. To that end, FDA’s Bad Ad program was created to
raise awareness in the medical community of potentially false or misleading or otherwise concerning
promotion and encourage health care professionals to critically evaluate all the promotional messages
to which they are exposed.
Conclusion
Together we can make a difference. As a health care professional, you can play an important role in
ensuring that prescription drug advertising and promotion is truthful by recognizing and reporting any
promotional activities of concern. If you believe you have witnessed a promotional activity of concern,
please send an email to badad@FDA.gov, or call 855-RX-BADAD, and submit a complaint. We’ll do the
rest.
