The Pharmaceutical Research and Manufacturers of America (PhRMA ) have issued new guidelines governing the interactions between member companies and healthcare providers. These guidelines went into effect January 1, 2009. Nashville Medical News spoke with Mr. Billy Tauzin about the guidelines. Mr. Tauzin is the president and CEO of PhRMA, a position he has held since January 2005. Prior to joining PhRMA, Mr. Tauzin served in the House of Representatives from Louisiana's 3rd District for 13 terms. He served as Chairman of the House Committee on Energy and Commerce.

 

PhRMA represents the leading research based pharmaceutical and biotechnology companies in the United States. The mission of PhRMA is to conduct effective advocacy for public policies that encourage discovery of important new medicines for patients by pharmaceutical research and biotechnology companies.

 

 

PhRMA's strengthened Code reaffirms that interactions between company representatives and healthcare professionals should be focused on informing healthcare professionals about the benefits and risks of medicines to help enhance patient care, providing scientific and educational information, and supporting medical research and education.

 

Interactions between physicians and pharmaceutical representatives benefit patient care through the exchange of information about new medicines, new uses of medicines, the latest clinical data, appropriate dosing, emerging safety issues and more.

 

Most importantly, our new voluntary Code – which was developed with input from physician groups, medical groups, company representatives and other stakeholders – will help ensure that this exchange of information continues in a professional, responsible manner that meets the highest ethical standards.

 

As for changes that a physician might notice in his or her office, the revised Code contains several provisions that reflect the tighter focus on education and information exchange. For example, the Code permits companies to provide physicians occasionally with items of minimal value ($100 or less) that will help educate physicians or patients, but specifies that items that do not have educational value – pens, clipboards and other "reminder" items – are deemed inappropriate. The Code acknowledges that such reminder items, even those of minimal value, "may foster misperceptions that company interactions with healthcare professionals are not based on informing them about medical and scientific issues."

 

The revised Code also prohibits company field sales representatives from providing meals to healthcare professionals in restaurants, but permits occasional, modest meals in a physician's office or hospital in conjunction with informational presentations.

 

Pharmaceutical marketing and education plays a critical role in improving patient care and fostering the appropriate use of medicines. And appropriate marketing of medicines arms physicians and other healthcare professionals with the latest information available on new treatments, medical advances and safety-related developments.

 

As someone who has battled a life-threatening form of cancer, I know that patients want their doctors to be as well-informed and up to date as possible. Pharmaceutical companies that discover and develop new medicines are the most knowledgeable about their products and are in the best position to inform healthcare professionals about a wide range of related topics. Company representatives are well-prepared and highly-trained to provide the latest scientific information about the medicines developed by their research-based companies, and can answer an array of questions about drugs and their characteristics, including the benefits, risks, proper use and side effects of treatments.

 

And importantly, this information exchange goes both ways: physicians provide pharmaceutical companies valuable feedback on how medicines are working for patients.

 

Our revised Code reinforces companies' commitment to ensure that all such interactions with healthcare professionals are focused on providing benefit to patients and advancing health education, and follow the highest ethical standards and legal requirements.

 

In the end, patients, physicians and manufacturers all benefit from these professional, ethical information exchanges.

 

This is an interesting question. I suppose some may argue that limits on meals, pens and the like are unnecessary and could even be insulting to physicians, but perceptions of undue influence often overshadow the reality that physicians have always written prescriptions with their patients' best interests firmly in mind. We are proud of the work our companies do every day on behalf of patients – and we take our collective responsibilities to patients very seriously. We have worked in this revised Code to address perceptions and yet preserve the important interactions between our companies and physicians.

 

Our companies already were committed to appropriate, ethical relationships with healthcare professionals. We expect our strengthened Code will serve to reinforce this commitment.

 

Yes, the revised Code was developed with input from many interested parties, including physician groups and medical groups. This was very important to us. We wanted a wide range of perspectives and I believe the end result reflected this outreach.

 

Perhaps a testament to these efforts, our new Code was received very positively by the medical community, with several groups publicly stating their appreciation for our work. 

 

As I mentioned earlier, the revised voluntary Code reflects the ongoing commitment of PhRMA's member companies – and many non-member companies as well – to pursue policies and practices that best serve the needs of patients and the healthcare community.

 

PhRMA principles and guidelines are continuously revisited, informed by our ongoing discussions with physicians, medical groups and other healthcare stakeholders. PhRMA has offered guidelines related to interactions with U.S. healthcare professionals since 1989. This strengthened Code builds on the standards and principles set forth in the previous version adopted in July 2002.

 

Certainly many industries engage in self-regulation, but we believe our efforts are unique in many ways. Even though the pharmaceutical research industry is among the most highly regulated industries in the country, our companies have long shown a commitment to go beyond regulatory requirements and self-impose what are, in some cases, even stricter voluntary standards. We've done this with our Code on Interactions with Healthcare Professionals, as well as other voluntary guidelines covering such issues as direct-to-consumer advertising and the conduct of clinical trials. 

 

Why do we do it? Because we're committed to pursuing policies and practices that best serve the needs of patients.

 

As with all our principles and guidelines, we will review the Code on an ongoing basis. Also, under the Code, companies that commit to conform to the outlined standards and principles will undergo an annual certification that they have policies and procedures in place to foster compliance with the Code. These certifications will be signed by the company's CEO and chief compliance officer.

 

A listing of all companies – both PhRMA members and non-members – that pledge to abide by the Code is posted on PhRMA's Web site for all to see, as will a list of companies that complete the annual certifications.

 

 

Brent Moody, MD, is the founder and Medical Director of the Skin Cancer & Surgery Center in Nashville. Dr. Moody is a Mohs Micrographic Surgeon and skin cancer specialist.