Discussing Brand Versus Generic Medications

Seema Ledan, PharmD

Disclosures

US Pharmacist. 2020;45(6):25-30. 

In This Article

Abstract and Introduction

Abstract

The FDA defines a generic drug as a "medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use." The U.S. healthcare system saved almost $2 trillion from 2009 to 2019 in healthcare costs due to generic use, with increased savings every year. Despite this variation in cost, barriers such as lack of communication and education, previous side effects, or preference may play a role in continued use of brand-name medications. Having an increased generic product market will create competition and, ultimately, lead to lower drug prices and access to affordable healthcare for more patients. It is important that pharmacists educate patients and providers on the appropriate use of generic versus brand medications.

Introduction

The FDA defines a generic drug as a "medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use."[1,2] Generic medications, therefore, are equivalent to brand-name products in terms of efficacy, quality, and safety. Abbreviated New Drug Applications (ANDAs) for generic approvals must show bioequivalence and that the active ingredient is the same as the brand name; they may differ based on the inactive ingredients, but these differences must be proven to have no effect on how the medication works.[1–3]

The 1984 Drug Price Competition and Patent Term Restoration Act, or Hatch-Waxman Act, allowed for generics to be approved for market use without preclinical and clinical testing to ensure a generic would be lower in cost compared with its equivalent branded product. Generics range from 80% to 85% lower in cost when compared with their brand product.[1] According to the IQVIA 2019 data, the U.S. healthcare system saved almost $2 trillion from 2009 to 2019 due to generic usage, with increased savings every year.[4,5] According to a report by the Association of Accessible Medicines (AAM), 4 billion generic prescriptions were filled in 2018 in the U.S., which represented 90% of prescriptions filled in the U.S. However, this only accounted for 22% of all drug spending.[5]

Due to perceptions or past experiences with generic medications, some consumers continue to use brand-name medications despite this difference in cost, which may lead to an increase in consumer spending, patient dissatisfaction, and ultimately, a decrease in adherence. Answering questions or discussing the use of generic versus brand medications or inactive versus active ingredients with patients is an important role for pharmacists to help improve patient satisfaction, adherence, and quality of life. Having an increased market of generic products will create competition and, ultimately, lead to lower drug prices and access to affordable healthcare for more patients.[1]

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