benefit as the original brand-name medication. In summary, FDA states that a patient can substitute a generic product with the brand-name counterpart (FDA, 2021). While likely not a panacea, it seems apparent that an approach to lowering the cost of prescription drugs would be to increase the availability of alternative forms of expensive medications. The in- troduction of generic drug products should increase competition and drive down costs. Key concepts The process of determining generic and brand names occurs during the development of each medication. The procedures for this naming exercise are outlined below. At some point during the development of a medication, often during early clinical trials, the drug’s sponsor begins negotiation with the International Council of Nonproprietary Names (INN) to select a generic name for their candidate product. The official no - menclature for the generic name is the United States Adopted Name (USAN). A number of required attributes are considered during this process, to include: ● The name reflects the drug’s action and alignment with the naming scheme. ● The ability to readily translate the name into languages other than English. ● Its ease of pronunciation and difficulty in remembering (AMA, n.d). After selection of a USAN name, the World Health Organization’s (WHO) International Nonproprietary Name Programme evaluates the new generic name for compliance with its guidelines (Daley & Emery, 2019). After a generic name is determined, the drug sponsor must make a critical decision: “what proprietary name should we select?” The trademarked “brand” name carries tremendous value to the promotion of a medication. To that end, companies spend an es- timated $500,000 dollars for the branding of each new drug. This process is difficult and often fraught with challenges. The sponsor must successfully navigate the U.S. Food & Drug Administration (FDA) as well as the U.S. Patent & Trademark Office (USPTO). FDA heavily relies on its Division of Medication Error Prevention and Analysis, whose remit is to prevent medication errors. One of their key responsibilities is to avoid “look alike, sound alike” How are brand-name and generic medications the same? FDA requires that all approved generic drugs employ the same mechanism of action and provide comparable benefits and risks as their brand- name counterpart. This is achieved by requiring that the generic medication have the same dosage, safety, effec- tiveness, strength, stability, quality, and route of administration as its predecessor, brand-name product. Generic drugs must meet the same quality standards as the brand- name medication. This is documented by a systematic and thorough pre-approval review process. After approval of a generic product, FDA continues mon- itoring the manufacturer to ensure that these quality requirements are maintained (FDA, 2021). In an effort to promote further competition, in 2017, FDA estab- lished the Drug Competition Action Plan. This strategy was de- signed to allow greater efficiency and enhance transparency to the generic drug review process without sacrificing the rigors of the scientific review process. Its intentions were to remove bar - How are brand-name and generic medications different? Although the active ingredients are the same in branded and ge - neric drugs, there may be differences; some subtle, others obvi - ous. FDA does not require that the inactive ingredients are the same as long as the differences do not impact performance. Ad - ditionally, in many cases, the color, shape, and size of the generic product will differ from the branded medication (PharmaEduca-
According to a 2019 article published by Conrad & Lutter, it was suggested that the greater the level of competition, the lower the price for generic drugs. More specifically, they show that, on average, the first approved generic product is priced at a 39% dis - count relative to the original branded product. As more generic products are approved and enter the market, the cost continues to fall; when 6 or more generic options are available, prices are reduced by more than 95% relative to the branded product (Con- rad & Lutter, 2019). errors due to misidentified medications or prescriptions (Daley & Emery, 2019). Self-Assessment Quiz Question #2 Regarding medication names, which of the following state- ments is true? a. The organization responsible for assigning generic names is International Council of Nonproprietary Names (INN). b. The World Health Organization (WHO) evaluates generic names. c. The selection of a proprietary name is often an afterthought. d. Both a and b. A naming example is the Pfizer® product Lipitor® (atorvastatin). In many, but not all cases, when a new drug is approved, it is pro- tected from competition by two defense mechanisms: patents and exclusivity. While both tools work in a similar fashion, there are distinctions that are underpinned by different and separate statutes. Patents issued by the USPTO are a property right and can cover a variety of claims. Exclusivity, on the other hand, grant- ed by FDA, governs the approval of competing generic drugs. FDA is not permitted to approve a generic drug so long as the predecessor drug retains exclusive rights to market it. Exclusivi- ty is intended to strike a fair balance between the promotion of innovation while allowing competition to provide greater public access to medications (FDA, 2020). When all applicable patents and exclusivity expire, the FDA may begin to approve generic medications, allowing multiple versions of medications to enter the market. riers to generic drug development and spur the rate of market entry of generic products. The overall objective was to increase competition, reduce prices and provide greater access to medi- cines at more affordable prices (FDA, 2022a). Self-Assessment Quiz Question #3 Generic medications are largely designed to match existing brand-name products. Which of the following is not an attri- bute of generic drug products? a. The same route of administration as the predecessor. b. The dosage is identical to the innovator product. c. The safety profile is not expected to differ from the brand- name product. d. An enhanced level of effectiveness relative to the brand- name product. tion n.d.). One exception is for warfarin tablets. Due to the nar - row therapeutic index of this medication, it is critical that patients receive the proper dose of medication. As a result, the color scheme is approximately the same for each strength, regardless of manufacturer (UCSD Health, n.d.).
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