Questions and Answers for Peer Speakers Program for Health Care Professionals

Questions and Answers for Peer Speakers Program for Health Care Professionals

Why do biopharmaceutical companies sponsor peer speaker programs for health care professionals?

Doctors and other healthcare professionals with real-world clinical experience in specific therapeutic areas are uniquely qualified to educate and inform their peers about the medicines they prescribe. While physicians consult many sources for information, it can be a challenge for them to juggle the demands of clinical practice with the need to stay up-to-date with the latest science and FDA-approved treatment options.

Interactions between physicians, including those participating in speakers bureaus, benefit patient care by facilitating the exchange of the latest FDA-regulated information (see below). This information exchange goes both ways: physicians provide pharmaceutical companies valuable feedback on how medicines are working for patients.

What value do speakers programs provide in improving patient care?

Interactions between healthcare professionals benefit patient care through the exchange of the latest regulated information about the benefits, risks and appropriate uses of medicines. Physicians need to stay up-to-date on information about new medicines, new uses of medicines, the latest clinical data, appropriate dosing and emerging safety issues.

What qualifications do companies look for when selecting speakers?

The PhRMA Code on Interactions with Healthcare Professionals, which was strengthened in 2008, contains detailed provisions specific to the conduct and training of speakers. Under the PhRMA Code, company decisions regarding the selection of healthcare professionals are based on defined criteria such as medical expertise, reputation, knowledge and experiences in a particular therapeutic area, and communication skills.

Companies often look to more specific criteria as well, including experience with the relevant medicine, faculty or medical society affiliations, leadership positions, authorship in the relevant therapeutic area, speaking experience, and participation in clinical trials.

What are companies doing to ensure their speakers meet the necessary criteria?

Companies have policies, procedures, and training in place to foster compliance with provisions of the PhRMA Code governing speaker programs, including conducting periodic reviews of speakers to ensure they still meet the requisite qualifications.

What are companies doing about doctors who have previously worked as peer speakers but have faced disciplinary actions?

Our companies are committed to ensuring that their relationships with healthcare providers reflect the highest possible ethical and professional standards. In all cases, they strive to work with healthcare professionals who embody this commitment. In the rare instance where there is an outlier – a speaker who falls short of the high standards reflected in the Code and company policies – companies take corrective action.

Are biopharmaceutical companies ethical and transparent in their work with healthcare professionals?

PhRMA companies are deeply committed to responsible, ethical interactions with healthcare professionals, as evidenced by the strengthened PhRMA Code, their robust compliance programs, and their recent support of related legislation, such as the Physician Payment Sunshine provision in the healthcare reform law. Appropriate transparency in relationships between biopharmaceutical research companies and healthcare professionals can help build patients’ trust in the healthcare system.

Can pharmaceutical promotion place undue pressure on healthcare professionals to prescribe certain medicines?

Healthcare providers make prescribing decisions in the best interests of their patients. They consider information from a variety of sources in order to provide the best care for their patients; in reality, information that affects prescribing decisions can include peer-reviewed journals, insurance guidelines and formularies, the physician’s own experience, and, most importantly, each patient’s unique situation. Recent prescribing trends reflect these influences, particularly insurer strategies such as tiered co-pays and prior authorization. Today, 75 percent of all prescriptions are filled by generic drugs, up from 47 percent in 2000.

What is the effect of pharmaceutical marketing on healthcare spending?

Medicines make up only about 10 percent of health care costs. Further, research has shown that many other factors have a greater influence on physician prescribing than pharmaceutical marketing. Public and private insurers and prescription benefit managers (PBMs) apply utilization management techniques to prescription drugs. Formularies, tiered co-pays, and prior authorization and step therapy requirements often steer patients and physicians toward use of some drugs and typically are designed to increase the use of generics over brand medicines. As a result, nearly all medicines used by insured patients are either generic or preferred brand.

Do companies have input into what speakers say?

Companies engaging physicians to lead peer education sessions must comply with federal and state requirements and stringent self-imposed standards to help ensure that the scientific information presented is accurate and up-to-date, with a fair balance of benefits and risks. The companies closely monitor content of these peer education sessions because FDA holds all companies accountable for the presentations of their speakers; materials presented at these forums must be reviewed by FDA and consistent with approved product labeling.

How do companies ensure that materials and presentations are compliant?

In addition to providing all speakers with appropriate training, companies periodically monitor speaker programs for compliance with FDA regulatory requirements.

Why do companies compensate physicians to speak for them?

Companies strive to provide accurate, up-to-date information to healthcare professionals about available treatment options and the benefits and risks of the medicines they develop. Similarly, physician speakers feel a strong commitment to the patients that they and other healthcare providers serve, and view presenting at peer education sessions as an opportunity to engage with their peers to improve patient care. This inevitably results in time away from their practice. Compensation for this time is, per the PhRMA Code, to be reasonable and at fair-market value for the services provided.

Are there rewards for physicians in exchange for prescribing more of a company’s medicine?

Federal law and the PhRMA Code clearly prohibit companies from retaining physicians as speakers in order to induce or reward the physicians for prescribing a particular medicine or course of treatment. Company decisions regarding the selection of healthcare professionals are based on defined criteria such as medical expertise, reputation, knowledge and experiences in a particular therapeutic area, and communication skills.

Do physician speakers encourage prescribing drugs for off-label uses?

Federal law and the PhRMA Code strictly prohibit companies from promoting a drug for a use other than for the FDA-approved indication(s), and these prohibitions extend to physicians who speak to their peers at a company’s request. Companies take their commitment to compliance very seriously – they train speakers on FDA requirements, monitor speaker programs periodically, and take swift corrective action if any physician speakers engage in conduct that could be viewed as off-label promotion.

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