Revised PhRMA Code Provides a New Roadmap

Advances in medicine and science continue at a breakneck pace and the need to keep physicians and other health care professionals (HCPs) abreast of these advances will grow ever more critical. Providing physicians with up-to-date, accurate information about the medicines they prescribe clearly improves patient care and advances health care in general. Nonetheless, the public health need for informed and educated HCPs may, at times, create tension with the pharmaceutical industry's perceived drive for profits.

Some have reported that the pharmaceutical industry directs up to 90% of its $20-plus billion dollar marketing budget toward physicians. See, e.g., Troyen A. Brennan, et al., Health Industry Practices that Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers,” JAMA, Jan. 25, 2006 at p. 430. Research indicates that the impact of gifts ' such as meals, conferences and other benefits ' on physician prescribing practices is a legitimate concern. See Ashley Wazana, M.D., “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?” JAMA, Jan.19, 2000 at pp. 373-380. Reports and study findings of this nature arguably create an “appearance of impropriety” that may be harmful to the professional image of physicians and pharmaceutical manufacturers alike, as well as impact public trust.

In response to growing concerns regarding the potential impact of gifts on physician prescribing habits, professional groups have been taking steps to guide physicians and/or to ban gifts. For example, the American Medical Association (AMA) has established clear ethical guidelines that govern physician interaction with the pharmaceutical industry; the AMA Principles of Medical Ethics and the AMA Code of Medical Ethics are intended to ensure that physicians do not place their own financial interests above the welfare of their patients and that their medical recommendations are not inappropriately influenced by financial considerations.

Similarly, in 2002, the Pharmaceutical Research and Manufacturers of America (PhRMA) adopted its marketing Code on Interactions with Healthcare Professionals to govern the pharmaceutical industry's relationships with physicians and other HCPs (“Code” or “PhRMA Code”). Many saw this at too little a check on undue influence over HCP prescribing decisions.

In response, on July 10, PhRMA released a new version of its voluntary Code. The changes, which take effect in January 2009, recognize that interactions between drug company representatives and HCPs should be designed to benefit patients and to enhance the practice of medicine.

The Updated Code

The revised PhRMA Code is broken down into 15 areas of concern. A number of changes in the new Code pertain to gifts and meals offered to physicians and their staff by pharmaceutical sales representatives. Regarding the day-to-day impact on interactions between company representatives and physicians, other HCPs and their staff, the gifts and meals prohibitions will have the most direct effects.

Gifts

Under the 2002 PhRMA Code, items of minimal value ($100 or less) that are primarily for the benefit of patients are deemed appropriate. Thus, operating under the 2002 Code, company representatives currently distribute pens, mugs, notepads and other “reminder” items (which frequently carry company logos) during office visits to HCPs. When the revised PhRMA Code takes effect in January 2009, company representatives will be prohibited from providing HCPs with “non-educational” items even if such items are deemed practice-related and are of minimal value. Thus, now commonly distributed “reminder” items (such as the ones listed above) will be prohibited.

The key to this change is a shift in the standard applied under the revised PhRMA Code. Specifically, the revised Code prohibits the provision of items to HCPs that do not “advance disease or treatment education.” The stated rationale supporting this prohibition is that providing such non-educational items could foster misperceptions that the company's interactions with HCPs are not based on providing information about medical and scientific issues. Therefore, companies should not offer non-educational items to HCPs or their staff, even if said items are accompanied by educational materials. It remains appropriate, however, for company representatives to provide product drug samples for patient use in accordance with the Prescription Drug Marketing Act.

In contrast to the across-the-board prohibition on providing “non-educational” items, the revised Code provides that certain “educational” items may be offered. Educational items are defined as those items “designed primarily for the education of patients or healthcare professionals.” Under the new PhRMA Code, educational items may be offered if they are not of substantial value ($100 or less) and do not have value to HCPs outside of their professional responsibilities. For example, while medical equipment (such as stethoscopes) plays an important role in patient care, such equipment is primarily designed for patient “care,” not for patient or HCP “education.” As such, it would be inappropriate for companies to offer stethoscopes or similar medical equipment to HCPs. By way of further example, although a DVD or CD player may be used to provide education to patients, such equipment may have independent value to a HCP outside of his or her professional responsibilities. Accordingly, a DVD or CD player is not an appropriate offering under the revised PhRMA Code. Significantly, under the revised PhRMA Code, educational items should not be offered on more than an “occasional basis,” even if each individual item is appropriate.

Similarly, to ensure that interactions are focused on educational and informational exchanges, as well as to avoid the appearance of impropriety, the revised Code says that companies should not provide entertainment or recreational items to physicians, other HCPs or their staff. Thus, theater tickets, sporting events tickets, sporting equipment, or leisure (vacation) trips are deemed inappropriate offerings to physicians, other HCPs or their staff under the revised Code.

While the revised PhRMA Code does not contain an exhaustive list of gift “do's” and “don'ts,” examples of inappropriate and appropriate gift items include the following:

Inappropriate Gifts

• “Reminder” items ( e.g., pens, notepads, mugs);
• Prescription notepads;
• Medical equipment used in patient care ( e.g., stethoscopes);
• Pedometers, stop watches or other general fitness items;
• DVD or CD player;
• Entertainment / Recreational items ( e.g., golf bags, golf

  balls, sports bags, theater/sporting events tickets, etc.

  Appropriate Gifts
• A medical textbook;
• A subscription to a relevant scientific journal;
• Copies of relevant clinical treatment guidelines;
• Anatomical models for patient examination rooms (if under $100);
• Written materials that inform patients about adherence to medicine regimens; and
• Patient starter kits that enhance the patients' appropriate use of the prescribed medicine.

Meals

The 2002 Code allows for occasional meals that take place in conjunction with informational presentations. Further, the 2002 Code provides that meals should be modest in value, served in a venue or environment conducive to education and should not include spouses. Under the revised Code, meals must be modest and offered in connection with informational presentations made by field sales representatives or their immediate managers. The provision of modest meals should be limited to in-office or in-hospital settings. Simply dropping off food for the office staff is not consistent with the revised Code. Moreover, restaurant meals are generally prohibited under the new Code.

Thus, under the new Code, a sales representative providing scientific or educational information regarding a company's product to one or more HCPs working in the same office, could provide a modest meal, such as sandwiches or pizza. Providing such modest meals on more than an occasional basis, however, is not appropriate. The updated Code does allow companies to use unrestricted grant money from a supporting company to provide meals for participants at Continuing Medical Education events.

Conclusion

Physician prescribing decisions are heavily dependent on the quality of the scientific information available and provided to them, in part, by pharmaceutical company sales representatives. Without question, there is a clear need for interactions between physicians and the pharmaceutical industry to ensure the free flow of valid scientific information. The enhanced PhRMA Code represents the latest development in an ongoing movement to ensure that industry interactions with physicians and other HCPs do not compromise those professionals' ability to provide high-quality, cost-effective care to their patients.

As spelled out in the new PhRMA Code, nothing should be offered or provided by companies in a manner or on conditions that would interfere with the independence of a physician's or HCP's prescribing practices. Attorneys counseling physicians and/or pharmaceutical manufacturers should be aware of the continued initiatives of PhRMA and other professional groups to further restrict gift giving in an effort to avoid the appearance of impropriety in the industry.

It should also be noted that while we have highlighted the prohibitions relating to interactions between drug and device company representatives and physicians, other HCPs and their staff, the revised PhRMA Code also provides key changes relating to HCPs participating in company-sponsored speaker programs and HCPs who are members of committees that set formularies or develop clinical practice guidelines. The revised version of the PhRMA Code is available, in its entirety, at http://www.phrma.org/files/PhRMA%20Marketing%20Code%202008.pdf.

Debra Sydnor, a member of this newsletter's Board of Editors, is a Partner in the Atlanta office of Alston & Bird LLP. She practices in the firm's Products Liability Group and concentrates her practice on defending product liability and toxic tort claims. In addition, she has over 10 years of experience defending medical malpractice litigation. She can be reached at [email protected].

Advances in medicine and science continue at a breakneck pace and the need to keep physicians and other health care professionals (HCPs) abreast of these advances will grow ever more critical. Providing physicians with up-to-date, accurate information about the medicines they prescribe clearly improves patient care and advances health care in general. Nonetheless, the public health need for informed and educated HCPs may, at times, create tension with the pharmaceutical industry's perceived drive for profits.

Some have reported that the pharmaceutical industry directs up to 90% of its $20-plus billion dollar marketing budget toward physicians. See, e.g., Troyen A. Brennan, et al., Health Industry Practices that Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers,” JAMA, Jan. 25, 2006 at p. 430. Research indicates that the impact of gifts ' such as meals, conferences and other benefits ' on physician prescribing practices is a legitimate concern. See Ashley Wazana, M.D., “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?” JAMA, Jan.19, 2000 at pp. 373-380. Reports and study findings of this nature arguably create an “appearance of impropriety” that may be harmful to the professional image of physicians and pharmaceutical manufacturers alike, as well as impact public trust.

In response to growing concerns regarding the potential impact of gifts on physician prescribing habits, professional groups have been taking steps to guide physicians and/or to ban gifts. For example, the American Medical Association (AMA) has established clear ethical guidelines that govern physician interaction with the pharmaceutical industry; the AMA Principles of Medical Ethics and the AMA Code of Medical Ethics are intended to ensure that physicians do not place their own financial interests above the welfare of their patients and that their medical recommendations are not inappropriately influenced by financial considerations.

Similarly, in 2002, the Pharmaceutical Research and Manufacturers of America (PhRMA) adopted its marketing Code on Interactions with Healthcare Professionals to govern the pharmaceutical industry's relationships with physicians and other HCPs (“Code” or “PhRMA Code”). Many saw this at too little a check on undue influence over HCP prescribing decisions.

In response, on July 10, PhRMA released a new version of its voluntary Code. The changes, which take effect in January 2009, recognize that interactions between drug company representatives and HCPs should be designed to benefit patients and to enhance the practice of medicine.

The Updated Code

The revised PhRMA Code is broken down into 15 areas of concern. A number of changes in the new Code pertain to gifts and meals offered to physicians and their staff by pharmaceutical sales representatives. Regarding the day-to-day impact on interactions between company representatives and physicians, other HCPs and their staff, the gifts and meals prohibitions will have the most direct effects.

Gifts

Under the 2002 PhRMA Code, items of minimal value ($100 or less) that are primarily for the benefit of patients are deemed appropriate. Thus, operating under the 2002 Code, company representatives currently distribute pens, mugs, notepads and other “reminder” items (which frequently carry company logos) during office visits to HCPs. When the revised PhRMA Code takes effect in January 2009, company representatives will be prohibited from providing HCPs with “non-educational” items even if such items are deemed practice-related and are of minimal value. Thus, now commonly distributed “reminder” items (such as the ones listed above) will be prohibited.

The key to this change is a shift in the standard applied under the revised PhRMA Code. Specifically, the revised Code prohibits the provision of items to HCPs that do not “advance disease or treatment education.” The stated rationale supporting this prohibition is that providing such non-educational items could foster misperceptions that the company's interactions with HCPs are not based on providing information about medical and scientific issues. Therefore, companies should not offer non-educational items to HCPs or their staff, even if said items are accompanied by educational materials. It remains appropriate, however, for company representatives to provide product drug samples for patient use in accordance with the Prescription Drug Marketing Act.

In contrast to the across-the-board prohibition on providing “non-educational” items, the revised Code provides that certain “educational” items may be offered. Educational items are defined as those items “designed primarily for the education of patients or healthcare professionals.” Under the new PhRMA Code, educational items may be offered if they are not of substantial value ($100 or less) and do not have value to HCPs outside of their professional responsibilities. For example, while medical equipment (such as stethoscopes) plays an important role in patient care, such equipment is primarily designed for patient “care,” not for patient or HCP “education.” As such, it would be inappropriate for companies to offer stethoscopes or similar medical equipment to HCPs. By way of further example, although a DVD or CD player may be used to provide education to patients, such equipment may have independent value to a HCP outside of his or her professional responsibilities. Accordingly, a DVD or CD player is not an appropriate offering under the revised PhRMA Code. Significantly, under the revised PhRMA Code, educational items should not be offered on more than an “occasional basis,” even if each individual item is appropriate.

Similarly, to ensure that interactions are focused on educational and informational exchanges, as well as to avoid the appearance of impropriety, the revised Code says that companies should not provide entertainment or recreational items to physicians, other HCPs or their staff. Thus, theater tickets, sporting events tickets, sporting equipment, or leisure (vacation) trips are deemed inappropriate offerings to physicians, other HCPs or their staff under the revised Code.

While the revised PhRMA Code does not contain an exhaustive list of gift “do's” and “don'ts,” examples of inappropriate and appropriate gift items include the following:

Inappropriate Gifts

• “Reminder” items ( e.g., pens, notepads, mugs);
• Prescription notepads;
• Medical equipment used in patient care ( e.g., stethoscopes);
• Pedometers, stop watches or other general fitness items;
• DVD or CD player;
• Entertainment / Recreational items ( e.g., golf bags, golf

  balls, sports bags, theater/sporting events tickets, etc.

  Appropriate Gifts
• A medical textbook;
• A subscription to a relevant scientific journal;
• Copies of relevant clinical treatment guidelines;
• Anatomical models for patient examination rooms (if under $100);
• Written materials that inform patients about adherence to medicine regimens; and
• Patient starter kits that enhance the patients' appropriate use of the prescribed medicine.

Meals

The 2002 Code allows for occasional meals that take place in conjunction with informational presentations. Further, the 2002 Code provides that meals should be modest in value, served in a venue or environment conducive to education and should not include spouses. Under the revised Code, meals must be modest and offered in connection with informational presentations made by field sales representatives or their immediate managers. The provision of modest meals should be limited to in-office or in-hospital settings. Simply dropping off food for the office staff is not consistent with the revised Code. Moreover, restaurant meals are generally prohibited under the new Code.

Thus, under the new Code, a sales representative providing scientific or educational information regarding a company's product to one or more HCPs working in the same office, could provide a modest meal, such as sandwiches or pizza. Providing such modest meals on more than an occasional basis, however, is not appropriate. The updated Code does allow companies to use unrestricted grant money from a supporting company to provide meals for participants at Continuing Medical Education events.

Conclusion

Physician prescribing decisions are heavily dependent on the quality of the scientific information available and provided to them, in part, by pharmaceutical company sales representatives. Without question, there is a clear need for interactions between physicians and the pharmaceutical industry to ensure the free flow of valid scientific information. The enhanced PhRMA Code represents the latest development in an ongoing movement to ensure that industry interactions with physicians and other HCPs do not compromise those professionals' ability to provide high-quality, cost-effective care to their patients.

As spelled out in the new PhRMA Code, nothing should be offered or provided by companies in a manner or on conditions that would interfere with the independence of a physician's or HCP's prescribing practices. Attorneys counseling physicians and/or pharmaceutical manufacturers should be aware of the continued initiatives of PhRMA and other professional groups to further restrict gift giving in an effort to avoid the appearance of impropriety in the industry.

It should also be noted that while we have highlighted the prohibitions relating to interactions between drug and device company representatives and physicians, other HCPs and their staff, the revised PhRMA Code also provides key changes relating to HCPs participating in company-sponsored speaker programs and HCPs who are members of committees that set formularies or develop clinical practice guidelines. The revised version of the PhRMA Code is available, in its entirety, at http://www.phrma.org/files/PhRMA%20Marketing%20Code%202008.pdf.

Debra Sydnor, a member of this newsletter's Board of Editors, is a Partner in the Atlanta office of Alston & Bird LLP. She practices in the firm's Products Liability Group and concentrates her practice on defending product liability and toxic tort claims. In addition, she has over 10 years of experience defending medical malpractice litigation. She can be reached at [email protected].