Public healthLesson 4 of 4 in the course Policies and Regulatory Conditions Impacting Health Outcomes

FDA Drug Review, Pharmaceutical Supply Chains, and Prescription Affordability

5 flashcards · 4 quiz questions · 5 match pairs · 4 fill-in sentences · English

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Summary

The U.S. Food and Drug Administration (FDA) helps protect public health by regulating foods, drugs, biologics, medical devices, and other products. This lesson introduces the FDA’s responsibilities, how its rules are established, and why drugs are evaluated before they are made available to the public.

The FDA is a regulatory body within the U.S. Department of Health and Human Services (HHS). Its broad responsibility is to protect public health by helping ensure the safety and efficacy of the food supply and medical products.

All flashcards

FDA
A regulatory body within HHS that helps protect public health by overseeing foods and medical products.
Federal Register
The U.S. government’s official publication for notifying the public about agency actions, including regulations.
Supply-chain visibility
The ability to understand where products and materials are and how they are moving.
Pharmacy benefit manager (PBM)
An intermediary among insurers, employers, and government programs that negotiates prescription prices.
Medication affordability barrier
A cost-related obstacle that can prevent a person from obtaining or taking medicines as prescribed.

Quiz questions

  1. What is the legal basis for FDA regulations?Answer: They are required or authorized by statute.
  2. What is a primary purpose of Phase III clinical trials?Answer: To gather additional evidence about effectiveness and safety in larger studies.
  3. How can export restrictions imposed by a country disrupt pharmaceutical supply chains?Answer: They can limit international shipments as the country prioritizes domestic needs.
  4. Which circumstance contributes to high drug prices by limiting price competition?Answer: A medicine has no generic or comparable alternatives.

Based on Population Health for Nurses by Jessica Ochs, Sherry L. Roper, Susan M. Schwartz (OpenStax), licensed CC BY 4.0. Adapted into a summary, flashcards and quizzes.

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