After completing this chapter, the reader will be able to
- Describe the organization of a pharmaceutical company.
- Discuss opportunities for health care professionals (HCPs) within the pharmaceutical industry.
- Describe how HCPs are regulated in the pharmaceutical industry.
- Determine acceptable interactions between pharmaceutical companies and HCPs.
- List the components of a clinical response and personalized letter.
- Explain the importance of collecting adverse event information.
- Recommend methods for communicating safety information to consumers.
- Identify industry-associated organizations.
- Describe the role of the Division of Drug Information (DDI) at the Food and Drug Administration (FDA).
- List the main differences between the DDI and a typical drug information center.
- Illustrate the different types of drug information services provided by the FDA.
- Identify factors that guide the selection of a specific FDA-sponsored resource/Web site.
- Discuss student and professional opportunities within the FDA.
- Pharmaceutical companies' scientific or medical divisions are filled with highly trained HCPs working in a variety of specialized fields.
- The goal of the Pharmaceutical Research and Manufacturers of America's (PhRMA) Code on Interactions With Health Care Professionals (HCPs) is to provide transparency to HCPs and patients alike as to the motives and channels through which industry conducts business with external customers and business partners.
- Clinical response letters are written correspondences that contain company-approved content in response to an unsolicited request for medical information.
- Postmarketing surveillance allows companies and the Food and Drug Administration (FDA) to continually review the recorded adverse events with a medication to evaluate the safety profile and continued use of the medicine by patients exposed to its risks.
- The best way to communicate risk is still being decided by the FDA, and many programs are already in place such as Risk Evaluation and Mitigation Strategies (REMS), Risk Minimization Action Plans (RiskMAPs), patient package inserts, medication guides, and others.
- The FDA strives to advance public health by setting standards for the efficient approval of new products that are safe, effective, and helpful to the U.S. public in combination with serving as a source of reputable and fair science-based information for consumers to effectively use these products.
- The FDA has several proactive mechanisms to communicate information about human drug products to the public through Web sites, listservers, CDERLearn programs, continuing education, and drug safety podcasts.
There are many roles available to health care professionals (HCPs) within the pharmaceutical industry and regulating agencies. In industry, these roles span medical education, publications, marketing, medical information, and more. In regulatory affairs, the roles are usually separate functions supporting the organizational mission statement and generally pertain to ensuring the safe and effective use of medications available to the public. Job titles and descriptions may vary slightly from company to company or agency to agency, but the importance of HCPs within each area is constant across organizations.
Throughout this chapter the reader will become familiar with the organization of a pharmaceutical company, professional mentoring relationships, industry's regulated interactions with outside health care professionals, ...