Many countries have measures in place to limit advertising by pharmaceutical companies.
Pharmaceutical company spending on marketing far exceeds that of its research budget. In Canada, $1.7 billion was spent in 2004 to market drugs to physicians; in the United States, $21 billion was spent in 2002.
In 2005, money spent on pharmaceutical marketing in the United States
was estimated at $29.9 billion with one estimate as high as $57 billion. When the U.S. numbers are broken down, 56% was free samples, 25% was pharmaceutical sales representative "detailing" (promoting drugs directly to) physicians, 12.5% was direct to user advertising, 4% on detailing to hospitals, and 2% on journal ads. There is some evidence that marketing practices can negatively affect both patients and the health care profession.
To health care providers
Marketing
to health-care providers takes three main forms: activity by
pharmaceutical sales representatives, provision of drug samples, and
sponsoring continuing medical education
(CME). The use of gifts, including pens and coffee mugs embossed with
pharmaceutical product names, has been prohibited by PHRMA ethics
guidelines since 2008.
Of the 237,000 medical sites representing 680,000 physicians surveyed in
SK&A's 2010 Physician Access survey, half said they prefer or
require an appointment to see a rep (up from 38.5% preferring or
requiring an appointment in 2008), while 23% won't see reps at all,
according to the survey data. Practices owned by hospitals or health
systems are tougher to get into than private practices, since
appointments have to go through headquarters, the survey found.
13.3% of offices with just one or two doctors won't see representatives,
compared with a no-see rate of 42% at offices with 10 or more doctors.
The most accessible physicians for promotional purposes are
allergists/immunologists – only 4.2% won't see reps at all – followed by
orthopedic specialists (5.1%) and diabetes specialists (7.6%).
Diagnostic radiologists are the most rigid about allowing details –
92.1% won't see reps – followed by pathologists and neuroradiologists,
at 92.1% and 91.8%, respectively.
E-detailing is widely used to reach "no see physicians";
approximately 23% of primary care physicians and 28% of specialists
prefer computer-based edetailing, according to survey findings reported
in the 25 April 2011, edition of American Medical News (AMNews),
published by the American Medical Association (AMA).
PhRMA Code
The Pharmaceutical Research and Manufacturers of America
(PhRMA) released updates to its voluntary Code on Interactions with
Healthcare Professionals on 10 July 2008. The new guidelines took effect
in January 2009."
In addition to prohibiting small gifts and reminder items such as
pens, notepads, staplers, clipboards, paperweights, pill boxes, etc., the revised Code:
- Prohibits company sales representatives providing restaurant meals to healthcare professionals, but allows them to provide occasional modest meals in healthcare professionals’ offices in conjunction with informational presentations"
- Includes new provisions requiring companies to ensure their representatives are sufficiently trained about applicable laws, regulations, and industry codes of practice and ethics.
- Provides that each company will state its intentions to abide by the Code and that company CEOs and compliance officers will certify each year that they have processes in place to comply.
- Includes more detailed standards regarding the independence of continuing medical education.
- Provides additional guidance and restrictions for speaking and consulting arrangements with healthcare professionals.
Free samples
Free
samples have been shown to affect physician prescribing behavior.
Physicians with access to free samples are more likely to prescribe
brand name medication over equivalent generic medications. Other studies found that free samples decreased the likelihood that physicians would follow standard of care practices.
Receiving pharmaceutical samples does not reduce prescription
costs. Even after receiving samples, sample recipients remain
disproportionately burdened by prescription costs.
It is argued that a benefit to free samples is the “try it before
you buy it” approach. Free samples give immediate access to the
medication and the patient can begin treatment right away. Also, it
saves time from going to a pharmacy to get it filled before treatment
begins. Since not all medications work for everyone, and many do not
work the same way for each person, free samples allow patients to find
which dose and brand of medication works best before having to spend
money on a filled prescription at a pharmacy.
Continuing medical education
Hours spent by physicians in industry-supported continuing medical education (CME) is greater than that from either medical schools or professional societies.
Pharmaceutical representatives
Currently, there are approximately 81,000 pharmaceutical sales representatives in the United States
pursuing some 830,000 pharmaceutical prescribers. A pharmaceutical
representative will often try to see a given physician every few weeks.
Representatives often have a call list of about 200-300 physicians with
120-180 targets that should be visited in 1-2 or 3 week cycle.
Because of the large size of the pharmaceutical sales force, the
organization, management, and measurement of effectiveness of the sales
force are significant business challenges. Management tasks are usually
broken down into the areas of physician targeting, sales force size and
structure, sales force optimization, call planning, and sales forces
effectiveness. A few pharmaceutical companies have realized that
training sales representatives on high science alone is not enough,
especially when most products are similar in quality. Thus, training
sales representatives on relationship selling techniques in addition to
medical science and product knowledge, can make a difference in sales
force effectiveness. Specialist physicians are relying more and more on
specialty sales reps for product information, because they are more
knowledgeable than primary care reps.
The United States has 81,000 pharmaceutical representatives or 1 for every 7.9 physicians. The number and persistence of pharmaceutical representatives has placed a burden on the time of physicians.
"As the number of reps went up, the amount of time an average rep
spent with doctors went down—so far down, that tactical scaling has
spawned a strategic crisis. Physicians no longer spend much time with
sales reps, nor do they see this as a serious problem."
Marketers must decide on the appropriate size of a sales force
needed to sell a particular portfolio of drugs to the target market.
Factors influencing this decision are the optimal reach (how many
physicians to see) and frequency (how often to see them) for each
individual physician, how many patients suffer from that disease state,
how many sales representatives to devote to office and group practice
and how many to devote to hospital accounts if needed. To aid this
decision, customers are broken down into different classes according to
their prescription behavior, patient population, and of course, their
business potential.
Marketers attempt to identify the set of physicians most likely
to prescribe a given drug. Historically, this was done by measuring the
number of total prescriptions (TRx) and new prescriptions (NRx) per week
that each physician writes. This information is collected by commercial
vendors. The physicians are then "deciled" into ten groups based on
their writing patterns. Higher deciles are more aggressively targeted.
Some pharmaceutical companies use additional information such as:
- Profitability of a prescription (script),
- Accessibility of the physician,
- Tendency of the physician to use the pharmaceutical company's drugs,
- Effect of managed care formularies on the ability of the physician to prescribe a drug,
- The adoption sequence of the physician (that is, how readily the physician adopts new drugs in place of older treatments), and
- The tendency of the physician to use a wide palette of drugs
- Influence that physicians have on their colleagues.
Physicians are perhaps the most important component in sales. They
write the prescriptions that determine which drugs will be used by
people. Influencing the physician is the key to pharmaceutical sales.
Historically, this was done by a large pharmaceutical sales force. A
medium-sized pharmaceutical company might have a sales force of 1000
representatives.
The largest companies have tens of thousands of representatives around
the world. Sales representatives called upon physicians regularly,
providing clinical information, approved journal articles, and free drug
samples. This is still the approach today; however, economic pressures
on the industry are causing pharmaceutical companies to rethink the
traditional sales process to physicians. The industry has seen a large
scale adoption of Pharma CRM systems that works on laptops and more
recently tablets.
The new age pharmaceutical representative is armed with key data at his
fingertips and tools to maximize the time spent with physicians.
Peer influence
- Key opinion leaders
Key opinion leaders (KOL), or "thought leaders", are respected
individuals, such as prominent medical school faculty, who influence
physicians through their professional status. Pharmaceutical companies
generally engage key opinion leaders early in the drug development
process to provide advocacy and key marketing feedback.
Some pharmaceutical companies identify key opinion leaders through
direct inquiry of physicians (primary research). Recently,
pharmaceutical companies have begun to use social network analysis
to uncover thought leaders; because it does not introduce respondent
bias, which is commonly found in primary research; it can identify and
map out the entire scientific community for a disease state; and it has
greater compliance with state and federal regulations; because physician
prescribing patterns are not used to create the social network.
Alternatives to segmenting physicians purely on the basis of
prescribing do exist, and marketers can call upon strategic partners
who specialize in delineating which characteristics of true opinion
leadership, a physician does or does not possess. Such analyses can
help guide marketers in how to optimize KOL engagements as bona fide
advisors to a brand, and can help shape clinical development and
clinical data publication plans for instance, ultimately advancing
patient care.
- Colleagues
Physicians acquire information through informal contacts with their
colleagues, including social events, professional affiliations, common
hospital affiliations, and common medical school affiliations. Some
pharmaceutical companies identify influential colleagues through
commercially available prescription writing and patient level data.
Doctor dinner meetings are an effective way for physicians to acquire
educational information from respected peers. These meetings are
sponsored by some pharmaceutical companies.
Journal articles and technical documentation
Recent legal cases and US congressional hearings have provided access to pharmaceutical industry documents revealing new marketing strategies for drugs. Activities once considered independent of promotional intent, including continuing medical education and medical research,
are used, including paying to publish articles about promoted drugs
for the medical literature, and alleged suppression of unfavorable
study results.
Private and public insurers
Public and private insurers affect the writing of prescriptions by physicians through formularies
that restrict the number and types of drugs that the insurer will
cover. Not only can the insurer affect drug sales by including or
excluding a particular drug from a formulary, they can affect sales by
tiering, or placing bureaucratic hurdles to prescribing certain drugs.
In January 2006, the United States instituted a new public prescription
drug plan through its Medicare program. Known as Medicare Part D, this program engages private insurers to negotiate with pharmaceutical companies for the placement of drugs on tiered formularies.
To consumers
Only two countries as of 2008 allow direct to consumer advertising (DTCA): the United States and New Zealand.
Since the late 1970s, DTCA of prescription drugs has become important
in the United States. It takes two main forms: the promotion or creation
of a disease out of a non-pathologic physical condition or the
promotion of a medication. The rhetorical objective of direct-to-consumer advertising is to directly influence the patient-physician dialogue. Many patients will inquire about, or even demand a medication they have seen advertised on television.
In the United States, recent years have seen an increase in mass media
advertisements for pharmaceuticals.
Expenditures on direct-to-users advertising have more than quintupled in
the seven years between 1997 and 2005 since the FDA changed the
guidelines, from $1.1 billion in 1997 to more than $4.2 billion in 2005,
a 19.6% annual increase, according to the United States Government Accountability Office, 2006).
The mass marketing to users of pharmaceuticals is banned in over 30 industrialized nations, but not in the US and New Zealand, which is considering a ban.
Some feel it is better to leave the decision wholly in the hands of
medical professionals; others feel that users education and
participation in health is useful, but users need independent,
comparative information about drugs (not promotional information).
For these reasons, most countries impose limits on pharmaceutical mass
marketing that are not placed on the marketing of other products. In
some areas it is required that ads for drugs include a list of possible
side effects, so that users are informed of both facets of a medicine. Canada's
limitations on pharmaceutical advertising ensure that commercials that
mention the name of a product cannot in any way describe what it does.
Commercials that mention a medical problem cannot also mention the name
of the product for sale; at most, they can direct the viewer to a
website or telephone number operated by the pharmaceutical company.
Reynold Spector has provided examples of how positive and
negative hype can affect perceptions of pharmaceuticals using examples
of certain cancer drugs, such as Avastin and Opdivo, in the former case and statins in the latter.
Drug coupons
In the United States, pharmaceutical companies often provide drug coupons to consumers to help offset the copayments
charged by health insurers for prescription medication. These coupons
are generally used to promote medications that compete with
non-preferred products and cheaper, generic alternatives by reducing or
eliminating the extra out-of-pocket costs that an insurers typically
charge a patient for a non-preferred drug product.
Economics
Pharmaceutical company spending on marketing exceeds that spent on research.
In 2004 in Canada $1.7 billion a year was spent marketing drugs to
physicians and in the United States $21 billion were spent in 2002.
In 2005 money spent on pharmaceutical marketing in the United States
was estimated at $29.9 billion with one estimate as high as $57 billion.
When the US number are broken down 56% was free samples, 25% was
detailing of physicians, 12.5% was direct to users advertising, 4% on
hospital detailing, and 2% on journal ads. In the United States approximately $20 billion could be saved if generics were used instead of equivalent brand name products.
Although pharmaceutical companies have made large investments in
marketing their products, overall promotional spending has been
decreasing over the last few years, and declined by 10 percent from 2009
to 2010. Pharmaceutical companies are cutting back mostly in detailing
and sampling, while spending in mailings and print advertising grew
since last year.
Regulation and fraud
European Union
In the European Union, marketing of pharmaceuticals is regulated by EU (formerly EEC) Directive 92/28/EEC.
Among other things, it requires member states to prohibit off-label
marketing, and direct-to-consumer marketing of prescription-only
medications.
United States
In the United States, marketing and distribution of pharmaceuticals is regulated by the Federal Food, Drug, and Cosmetic Act and the Prescription Drug Marketing Act, respectively. Food and Drug Administration
(FDA) regulations require all prescription drug promotion to be
truthful and not misleading, based on "substantial evidence or
substantial clinical experience", to provide a "fair balance" between
the risks and benefits of the promoted drug, and to maintain consistency
with labeling approved by the FDA. The FDA Office of Prescription Drug
Promotion enforces these requirements.
In the 1990s, antipsychotics were "still seen as treatments for
the most serious mental illnesses, like hallucinatory schizophrenia, and
recast them for much broader uses". Drugs such as Abilify and Geodon
were given to a broad range of patients, from preschoolers to
octogenarians. In 2010, more than a half-million youths took
antipsychotic drugs, and one-quarter of nursing-home residents have used
them. Yet the government warns that the drugs may be fatal to some
older patients and have unknown effects on children.
Every major company selling the drugs—Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca, and Johnson & Johnson—has
either settled recent government cases, under the False Claims Act, for
hundreds of millions of dollars or is currently under investigation for
possible health care fraud. Following charges of illegal marketing, two
of the settlements in 2009 set records for the largest criminal fines
ever imposed on corporations. One involved Eli Lilly’s antipsychotic Zyprexa, and the other involved Bextra. In the Bextra case, the government also charged Pfizer with illegally marketing another antipsychotic, Geodon; Pfizer settled that part of the claim for $301 million, without admitting any wrongdoing.
The following is a list of the four largest settlements reached with pharmaceutical companies
from 1991 to 2012, rank ordered by the size of the total settlement.
Legal claims against the pharmaceutical industry have varied widely over
the past two decades, including Medicare and Medicaid fraud, off-label promotion, and inadequate manufacturing practices.
Company | Settlement | Violation(s) | Year | Product(s) | Laws allegedly violated (if applicable) |
---|---|---|---|---|---|
GlaxoSmithKline | $3 billion | Off-label promotion/failure to disclose safety data | 2012 | Avandia/Wellbutrin/Paxil | False Claims Act/FDCA |
Pfizer | $2.3 billion | Off-label promotion/kickbacks | 2009 | Bextra/Geodon/Zyvox/Lyrica | False Claims Act/FDCA |
Abbott Laboratories | $1.5 billion | Off-label promotion | 2012 | Depakote | False Claims Act/FDCA |
Eli Lilly | $1.4 billion | Off-label promotion | 2009 | Zyprexa | False Claims Act/FDCA |
Evolution of marketing
The
emergence of new media and technologies in recent years is quickly
changing the pharmaceutical marketing landscape in the United States.
Both physicians and users are increasing their reliance on the Internet
as a source of health and medical information, prompting pharmaceutical
marketers to look at digital channels for opportunities to reach their
target audiences.
In 2008, 84% of U.S. physicians used the Internet and other
technologies to access pharmaceutical, biotech or medical device
information—a 20% increase from 2004. At the same time, sales reps are
finding it more difficult to get time with doctors for in-person
details. Pharmaceutical companies are exploring online marketing as an
alternative way to reach physicians. Emerging e-promotional activities
include live video detailing, online events, electronic sampling, and
physician customer service portals such as PV Updates, MDLinx, Aptus
Health (former Physicians Interactive), and Epocrates.
Direct-to-users marketers are also recognizing the need to shift
to digital channels as audiences become more fragmented and the number
of access points for news, entertainment and information multiplies.
Standard television, radio and print direct-to-users (DTC)
advertisements are less relevant than in the past, and companies are
beginning to focus more on digital marketing efforts like product
websites, online display advertising, search engine marketing, social media campaigns, place-based media and mobile advertising to reach the over 145 million U.S. adults online for health information.
In 2010, the FDA's
Division of Drug Marketing, Advertising and Communications issued a
warning letter concerning two unbranded consumer targeted Web sites
sponsored by Novartis
Pharmaceuticals Corporation as the websites promoted a drug for an
unapproved use, the websites failed to disclose the risks associated
with the use of the drug and made unsubstantiated dosing claims.