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.

 

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