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The views expressed in this chapter do not necessarily represent the views of the Food and Drug Administration or the United States.

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Learning Objectives

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After completing this chapter, the reader will be able to

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  • Design an organization chart for a pharmaceutical company.

  • Discuss opportunities for health care professionals (HPs) within the pharmaceutical industry.

  • Describe how HPs are regulated in the pharmaceutical industry.

  • Determine acceptable interactions between pharmaceutical companies and practitioners.

  • List the components of a standard response and personalized letter.

  • Explain the importance of collecting adverse event information.

  • Identify pharmaceutical industry–associated organizations.

  • Recommend methods for communicating safety information to consumers.

  • 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 selection of a specific FDA-sponsored resource or Web site.

  • Discuss student and professional opportunities within the FDA.

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Key Concepts

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  1. Pharmaceutical companies' scientific or medical divisions are staffed with highly trained health care professionals (HPs) working in a multitude of specialized fields.

  2. Medical information specialists respond to inquiries, provide training, and draft materials for a variety of internal and external audiences.

  3. Pharmaceutical companies are regulated both externally by the FDA and internally by standard operating procedures (SOPs).

  4. The FDA's draft Guidance for Industry “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” describes the FDA's current thinking about how manufacturers and distributors of prescription human drug products can respond to unsolicited requests for information about unapproved indications (off-label information) related to their FDA-approved or cleared products.

  5. Unsolicited requests are those initiated by persons or entities that are completely independent of the relevant firm.

  6. The FDA considers requests for off-label information that are prompted in any way by a manufacturer or its representatives to be solicited.

  7. Interactions between pharmaceutical companies and HPs are defined, but not regulated, by a code of conduct established by the Pharmaceutical Research and Manufacturers of America (PhRMA) through the revised version of the Code on Interactions with Health Care Professionals.

  8. Clinical response letters are written correspondence that contains company-approved content in response to an unsolicited request for medical information.

  9. Patient variability, clinician experience, and previously unaddressed questions require personalized responses that cannot be fulfilled with a standard response letter.

  10. Adverse drug experiences, or adverse events, are required to be reported to the FDA by pharmaceutical companies.

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

  12. Timely communication of important drug safety information provides HPs, patients, consumers, and other interested persons with access to the most current information concerning the potential risks and benefits of a marketed drug, helping ...

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