US Pharm.
2008;33(9):44-46.
Although not the first time
the industry has attempted self-policing, on July 10, 2008, the Pharmaceutical
Research and Manufacturers of America (PhRMA), the trade group representing
traditional research-oriented drug companies and biotechnology firms,
announced revised guidelines that will impact how manufacturers market
prescription medicines to health care professionals.1 The changes,
accepted unanimously by PhRMA's members, are set to be implemented in January
2009. The preamble to the PhRMA Code contains the philosophy underlying its
purpose: "The Code is based on the principle that a health care professional's
care of patients should be based, and should be perceived as being based,
solely on each patient's medical needs and the health care professional's
medical knowledge and experience." The mission of PhRMA companies is to help
patients by developing and marketing new medicines. In other words, the Code
is all about the education of patients and health care professionals and not
just zealous marketing of drugs to increase sales.
In July 2002, the organization
promulgated a Code on Interactions with Healthcare Professionals.2
That effort was filled with loopholes and exceptions that practically wiped
out its actual impact on how drug companies get prescribers and pharmacists to
use their products. The new version, though still voluntary, puts some meat on
the restrictions that member groups will have to comply with if they intend to
operate within the rules. Nevertheless, there is still plenty of wiggle room
left in promoting drug utilization.
Changes Under the Revised
Guidelines
Gifts:
Perhaps the most notable change under the new standards is that drug companies
will have to forgo giveaways like pens, note pads, clipboards, and coffee
mugs with company logos or advertising about a particular drug.3
According to PhRMA, these "reminder items" may "foster misperceptions that
company interactions with health care professionals are not based on informing
them about medical and scientific issues."4 The "freebies"
are banned even if the reminder items do not have any logos or advertising.
Items intended for the personal benefit of health care professionals, such as
floral arrangements, automobile fuel, artwork, CDs, pedometers, stopwatches,
golf balls, or tickets to sporting events are prohibited. Payments in cash or
cash equivalents (such as gift certificates) either directly or indirectly are
banned, because payments of any kind create a potential appearance of
impropriety or conflict of interest.
Not all "gifts" to health care
professionals are banned. Purely educational items, like medical textbooks,
anatomical models, subscriptions to relevant scientific journals, or copies of
clinical treatment guidelines, are still acceptable to give away as long as
the value of the gift does not exceed $100, and gifts are only offered
occasionally.5 Distribution of drug samples to physicians is still
allowed. Giving away free stethoscopes is prohibited on the notion that such
medical equipment is not intended to educate patients or health care
professionals.6 It would, however, be appropriate for a company to
distribute educational brochures without pens or clipboards. The guidelines
also prohibit the distribution of freebies at third-party scientific and
educational conferences or professional meetings.
Meals:
Gone too are expensive meals at fancy restaurants and trips to resorts, along
with other forms of entertainment and recreation.7 Specifically
prohibited are theater tickets or vacation trips for any health care
professional who is not a salaried employee of the company, regardless of the
value of the items. However, modest meals (e.g., sandwiches or pizza) are
permitted as long as they are offered by sales representatives only
occasionally as a business courtesy to health care professionals and staff
members attending presentations. The presentations must provide scientific or
educational value and the meals cannot be part of an entertainment or
recreational event.8 If a meal is going to be offered in connection
with an informational presentation, it should be provided in the health
professionals' offices or in hospital settings. This means that the so-called
"dine and dash" programs, where take-out meals are provided, are banned. Also
prohibited is feeding a spouse or other guest.
There is one other loophole in
the prohibition on meals. A senior executive may still offer to pay for a meal
at a restaurant when meeting with a health care professional if the meal is
incidental to a substantial interaction. The meal offered must be modest as
judged by local standards, not be part of an entertainment or sporting event,
and must be offered in a venue conducive to informational communication.
Continuing Education:
Another change will occur in the way drug companies fund continuing education
(CE) programs. According to PhRMA, CE helps heath care professionals obtain
information and insights that can contribute to the improvement of patient
care. Therefore, financial support from companies for CE is appropriate as
long as it is intended to support education on a full range of treatment
options and not to promote a particular medicine. PhRMA recommends that a
company "separate its CE grant-making functions from its sales and marketing
departments. In addition, a company should develop objective criteria for
making CE grant decisions to ensure that the program is a bona fide
educational program and that the financial support is not an inducement to
prescribe or recommend a particular medicine or course of treatment."9
Giving a subsidy of any kind
directly to a health care professional is prohibited because it could be
construed as a cash gift. Instead, PhRMA directs that financial support should
be given to the CE provider, which, in turn, can use the money to reduce the
overall CE registration fee for all participants. In order to avoid undue
influence, a drug company is admonished to respect the independent judgment of
the CE provider and to follow standards for commercial support. Responsibility
for the selection of content, faculty, educational methods, materials, and
venue belongs to the organizers of the conferences or meetings. Companies
should not provide any advice or guidance to the CE provider, even if asked,
regarding the content or faculty. Companies will not be able to pay nonfaculty
for the costs of travel, lodging, or other personal expenses, either directly
or indirectly. It is not appropriate to pay honoraria to nonfaculty and
nonconsultant health care professional attendees at company-sponsored
meetings, including attendees who participate in interactive sessions. Funding
is also prohibited for the time spent by a health care professional to attend
a CE program. While pharmaceutical and biotechnology companies can no longer
pay for meals at a CE event, the CE provider can use monies from an otherwise
"unrestricted educational grant" provided by a company to pay for a meal.
Financial assistance for
scholarships or other educational funds to permit medical students, residents,
and fellows to attend select educational conferences (i.e., major educational,
scientific, or policymaking meetings of national, regional, or specialty
medical associations) may be offered as long as the selection of recipients is
made by the academic or training institution.10 This is a
significant development because academic institutions have increasingly
condemned the marketing practices of PhRMA members at educational venues due
to excessive pushing of individual products.
Consulting:
Another area addressed by the most recent PhRMA Code is paying health care
professionals as consultants to a drug company.11 This practice has
been controversial because some organizations have paid consultants who did
little if any actual consulting. The guidelines say that companies should take
steps to ensure that consultant arrangements are neither inducements nor
rewards for prescribing or recommending a particular medicine or course of
treatment. That warning aside, paid consultants are still acceptable under the
Code. Companies need to make sure the consultant does actually provide
advisory services and is paid only reasonable compensation for those services
and reimbursement for travel, lodging, and meal expenses incurred as part of
providing consulting services. Unfortunately, the Code does not provide any
guidance on what kinds of payments are considered reasonable.
Individual practitioners hired
by a company as speakers at a company sponsored meeting are also subject to
the new guidelines. Company decisions regarding the selection or retention of
health care professionals as speakers should be based on defined criteria such
as general health care expertise, reputation, knowledge, experience regarding
a particular therapeutic area, and communications skills.12
Companies should ensure that speaking arrangements are neither inducements nor
rewards for prescribing a particular medicine or course of treatment. Each
company is to independently cap the total amount of annual compensation it
will pay to an individual health care professional in connection with all
speaking arrangements. The dollar amount of the caps is not specified, but it
should be driven by marketplace economics. Each company also should develop
policies addressing the appropriate use of speakers and the appropriate number
of engagements for any particular speaker over time.
Health care professionals who
are speakers or consultants for a drug company and also serve as members of
formulary committees or develop clinical practice guidelines that may
influence the prescribing of medicines are directed by the Code to disclose to
the committee the existence and nature of their relationship with the company.13
This disclosure should last for at least two years beyond the termination of
any speaker or consultant arrangement. Upon disclosure, the speakers or
consultants are required to follow the procedures set forth by the committee,
which may include recusing themselves from decisions relating to the drugs for
which they have provided consulting services.
A participating company will
be required to provide an annual certification that it complies with all
aspects of the Code.14 The certification must be signed by the
company's chief executive officer and chief compliance officer. In addition,
companies are encouraged to seek external verification periodically (at least
once every three years). Certified companies will be listed on the PhRMA Web
site (www.pharma.org).
Reaction to the Code
A number of
companies, including Amgen, Eli Lilly, Johnson & Johnson, Merck, AstraZeneca,
Pfizer, and GlaxoSmithKline have announced their support of the Code.15
Pfizer stated that it will no longer fund CE programs run by for-profit third
parties because of an apparent conflict of interest. It will continue to fund
educational programs run by academic institutions and medical societies.16
This is no doubt a response to congressional findings that the drug industry
spends over $1 billion annually in educational grants intended to increase the
use of particular drugs.17 Pfizer alone spent $80 million in 2007
funding for-profit educational programs.
The timing of the Code's
release may have been serendipitous. The day before, Congress passed a
Medicare program that gives incentives to use electronic prescribing.18
The bill did not contain federal mandates to regulate drug marketing
and curb perceived abuses.
PhRMA supports federal
legislation that will require companies to disclose payments of $500 or more
to doctors, in any form.19 Vermont and Maine require drug companies
to publicly disclose all payments of $25 or more to any physician, hospital,
nursing home, pharmacist, and health benefit plan.20 The District
of Columbia and California also regulate drug promotion to individual health
care providers. Minnesota currently bans gifts to physicians of more that $50,
including food. Massachusetts is considering similar legislation.
Business As Usual?
Some critics contend that the voluntary provisions of the revised Code do not
go far enough. "It strikes me as an attempt to persuade people against doing
anything that's serious," said Sharon Treat, executive director of the
National Legislative Association on Prescription Drug Prices.21
In recent years, the drug
industry has spent between $22 billion and $57 billion annually on marketing
drugs to prescribers.22,23 At the low end, that amounts to $25,000
per physician per year.24 "While we welcome that PhRMA is taking a
step to limit small gifts, the Code in no way touches on the deeper,
more-structural problems in the practice of medicine, where the industry has
insinuated itself at the deepest levels," said Merrill Goozner, director of
the Integrity in Science Project at the Center for Science in the Public
Interest, a Washington, DC, advocacy group.25
REFERENCES
1. Code on
interactions with healthcare professionals.
www.phrma.org/code_on_interactions_with_healthcare_professionals. Accessed
July 10, 2008.
2. PhRMA code on
interactions with healthcare professionals. July 1, 2002.
http://cme.ouhsc.edu/phrmacode.pdf. Accessed July 11, 2008.
3. Johnson A. Drug
group sets marketing code. Wall Street Journal. July 11, 2008:B7.
http://online.wsj.com/article/SB121568650743242315.html?mod=2_1566_leftbox.
Accessed July 11, 2008.
4. PhRMA code on
interactions with healthcare professionals. Section 10, p. 11. Revised July
2008. www.phrma.org/files/PhRMA%20Marketing%20Code%202008.pdf. Accessed July
10, 2008.
5. See note 4, supra.
Section 11, p. 12.
6. See note 4, supra.
Section Q1, p. 18.
7. See note 4, supra.
Section 3, p. 5.
8. See note 4, supra.
Section 2, p. 4.
9. See note 4, supra.
Section 4, p. 6.
10. See note 4, supra.
Section 9, p. 11.
11. See note 4, supra.
Section 6, p. 6-9.
12. See note 4, supra.
Section 7, p. 9-10.
13. See note 4, supra.
Section 8, p. 10-11.
14. See note 4, supra.
Section 15, p. 14-15.
15. See note 3, supra.
16. Loftus P. Pfizer
ends direct funding of courses. Wall Street Journal. July 3, 2008:B11.
http://online.wsj.com/article/SB121500694573822937.html. Accessed July 13,
2008.
17. Id.
18. Werble C. PhRMA
marketing code: throw away those pens, the time is perfect. RPM Report. July
14, 2008.
http://therpmreport.com/Free/5af7495a-d826-45c2-b6de-ad502bfc6613.aspx?utm_source=SmartBrief.
Accessed July 15, 2008.
19. Drug industry
revising marketing code. NewsInferno. July 10, 2008.
www.newsinferno.com/archives/3429. Accessed July 13, 2008.
20. Scott RL. Vermont
law targets drug marketing. December 4, 2002.
www.law.uh.edu/healthlaw/perspectives/Food/021204Vermont.html. Accessed July
13, 2008.
21. Id.
22. Prescription drug
marketing. 2005 policy summary. Center for Policy Alternatives.
www.cfpa.org/publications/agenda/2005/pdf/prescriptiondrugmarketing.pdf.
Accessed July 13, 2008.
23. Weissman R.
Pharmaceutical payola--drug marketing to doctors. CorpWatch. May 22, 2008.
www.corpwatch.org/article.php?id=15044. Accessed July 13, 2008.
24. Prescription drug
marketing. Center for Policy Alternatives.
www.cfpa.org/issues/issue.cfm/issue/PrescriptionDrugMarketing.xml. Accessed
July 13, 2008.
25. See note 3, supra.
To comment on this article, contact rdavidson@jobson.com.