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During the development of a new pharmaceutical, the manufacturer initially assigns a code name to the drug. Once approved, the drug receives a United States Adopted Name (USAN)—a generic, nonproprietary designation. Upon being listed in the United States Pharmacopeia, this nonproprietary name becomes the drug's official name. Additionally, the manufacturer assigns a proprietary name or trademark, which serves as the brand name under which the drug is marketed. It is worth noting that...
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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
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Dosage Regimen: Individualization01:24

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Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
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'Most Favored Nation' Drug Pricing: An Idea To What End?

Andrew W Mulcahy1

  • 1Andrew W. Mulcahy (amulcahy@rand.org), RAND, Arlington, Virginia.

Health Affairs (Project Hope)
|April 6, 2026
PubMed
Summary

Most favored nation policies could lower US drug prices, but defining success requires value-based assessments. Further investment in US health technology assessment is crucial for setting appropriate drug pricing benchmarks.

Area of Science:

  • Health Economics
  • Pharmaceutical Policy
  • Drug Pricing

Background:

  • US brand-name drug prices significantly exceed international benchmarks.
  • Most favored nation (MFN) proposals suggest international reference pricing to lower US drug costs.
  • These policies may also increase prices in other countries towards US levels.

Purpose of the Study:

  • To evaluate the challenge of defining successful MFN policy implementation from a US perspective.
  • To identify the necessary criteria for determining appropriate net prices for brand-name drugs.
  • To highlight the importance of health technology assessment (HTA) in drug pricing.

Main Methods:

  • Conceptual analysis of MFN policies and international reference pricing.
  • Examination of value-based pricing principles in the US healthcare context.

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  • Discussion of the role of HTA in establishing drug price benchmarks.
  • Main Results:

    • MFN policies present a complex challenge in defining "success" based on net drug prices.
    • A US-focused, value-oriented perspective is essential for setting appropriate pricing goals.
    • Achieving this requires a clear definition of "right" prices, which is currently difficult to establish.

    Conclusions:

    • MFN policies require a defined endpoint for success, focusing on value-based net prices.
    • Investment in US health technology assessment research is critical for defining and achieving appropriate drug pricing.
    • Without robust HTA, setting successful international reference pricing benchmarks remains elusive.