Chapter Twenty-Four: Regulatory Affairs and Pharmaceutical Industry

Learning Objectives

After completing this chapter, the reader will be able to:

• Compare and contrast the missions of the Department of Health and Human Services (DHHS), the Food and Drug Administration (FDA), and Center for Drug Evaluation and Research (CDER).

• Describe the methods the FDA uses to communicate important safety information.

• Describe the role of the CDER Division of Drug Information (DDI).

• List the main services provided by the CDER DDI.

• Categorize the different clinical and regulatory resources provided by the FDA.

• Identify the FDA and DDI resources for small business and the pharmaceutical industry.

• Discuss student and professional opportunities within the FDA and the pharmaceutical industry.

• Describe how health care professionals (HCPs) are regulated in the pharmaceutical industry.

• Determine acceptable interactions between pharmaceutical companies and practitioners.

• Explain the importance of collecting adverse event and product complaint information.

Key Concepts

• The mission of the FDA is “to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”

• Accurate, clear, and timely communication of important safety information is necessary for health care providers, patients, and the public to make informed decisions on the risks and benefits of a therapy.

• The FDA uses an array of methods and tools to communicate drug, biologic, and medical device safety information to the public.

• The mission of the CDER Division of Drug Information (DDI) is to provide accurate, timely, and relevant information about human drug products through traditional and social media channels.

• Publicly available resources and databases developed by the FDA serve as authoritative references for pharmacists and HCPs across a variety of disciplines.

• The FDA offers a broad range of training, professional development, and employment opportunities for both current and future health professionals. Participation in an FDA scientific internship, fellowship, or training program allows one to gain direct practical experience in regulatory and clinical sciences.

• Pharmaceutical companies’ medical information practices are highly regulated by the FDA.

• Unsolicited requests are those initiated by persons or entities completely independent of influence by the relevant pharmaceutical company.

• To ensure ongoing safety of medications available to the American public, the FDA has established postmarketing surveillance programs to identify serious adverse events that may not have appeared during drug development or an increased incidence of known adverse events that may require changes in a product’s prescribing information and, rarely, reconsideration of the product’s approval status.

• Pharmaceutical companies’ scientific or medical departments are staffed with highly trained HCPs working in a multitude of specialized fields.