American College of Physicians Advocates for Greater Use of Generic Medications Over Brand-Name Drugs in Clinical Practice

The American College of Physicians (ACP), founded in 1915, is the largest medical specialty society in the United States, with a total membership of 143,000. Its members primarily include practicing clinical specialists and medical students currently enrolled in their studies. The ACP’s primary mission is to promote the health of the U.S. population by fostering excellence in professional standards and ethical conduct among physicians. Annals of Internal Medicine (ISSN: 0003-4819) is the official journal of the American College of Physicians. Established in 1927, it is a leading international journal in the field of internal medicine research, with an impact factor as high as 12.43. The journal publishes original articles, correspondence, news updates, and commentaries, addressing and answering numerous questions related to medical research and clinical practice. Through this journal, physicians can engage not only in peer-to-peer exchanges but also in dialogue with the general public beyond the medical community.



On November 24, 2015, the American College of Physicians published a landmark clinical practice guideline paper online in the Annals of Internal Medicine, titled “Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities From the Greater Use of Generic Medications: Best Practice Advice From the Clinical Guidelines Committee of the American College of Physicians.” The central message of the article advocates that all clinicians should prescribe generic medications rather than brand-name drugs whenever possible. This approach not only improves patients’ clinical outcomes but also effectively reduces unnecessary expenditures for both patients and the U.S. healthcare system. According to statistics from the ACP, if generic drugs were widely used to replace high-priced brand-name drugs in the routine care of common clinical conditions, it would save approximately $325 billion annually in U.S. prescription drug spending.

To facilitate a better understanding of the clinical medication guidelines on generic substitution for brand-name drugs proposed by the American Medical Association, it is essential to first understand what brand-name drugs and generic drugs are.

The U.S. pharmaceutical industry can be broadly categorized into two major segments: brand-name drugs and generic drugs. The brand-name drug sector is typically characterized by its large scale, strong brand recognition, and annual sales revenues reaching tens or even hundreds of billions of dollars. Well-known U.S. pharmaceutical companies such as Pfizer and Merck fall into this category. In contrast, the other branch of the U.S. pharmaceutical industry—the generic drug sector—may be less familiar to the general public. Although the sales volume of the generic drug industry cannot compare with that of the brand-name drug sector, its market size remains substantial. For instance, Teva, the leading company in the U.S. generic drug market in 2003, reported annual revenues of nearly $2 billion. It is important to clarify that generic drugs are not counterfeit medications; the term “generic” refers to copies of existing brand-name drugs. Generic drugs are pharmaceutically equivalent and therapeutically identical to their brand-name counterparts. The primary difference lies in naming conventions: generic drugs are typically named after the chemical name of their active ingredients. In the U.S. market, generic drugs can only enter the market after the patent protection for the corresponding brand-name drug has expired, and they are priced significantly lower than brand-name drugs. It is crucial to emphasize that generic drugs are subject to the same stringent government regulations and oversight as brand-name drugs. The U.S. Food and Drug Administration (FDA) has established a dedicated Office of Generic Drugs to oversee and manage this sector.

The process by which generic drugs enter the consumer market differs from that of brand-name drugs. Brand-name pharmaceutical companies typically employ a substantial sales force to lobby physicians, aiming to increase prescription volumes and expand market share. In contrast, generic drug manufacturers generally do not maintain sales representatives. Instead, they secure long-term agreements with major national pharmacy chains, through which their products are distributed and sold directly at retail. When pharmacists at these chains receive prescriptions for brand-name drugs, they substitute them with the corresponding generic equivalents in most cases. Consequently, frontline clinicians often end up recommending higher-priced brand-name drugs to patients, rather than lower-cost generics with equivalent efficacy.

Does U.S. national policy support generic drugs? The answer is yes! The generic drug industry is protected by U.S. national policies and relevant laws and regulations. The legal foundation of the modern U.S. generic drug industry is the Hatch-Waxman Act, enacted in 1984. The Medicare Modernization Act, passed in late 2003, introduced certain modifications and adjustments to the details of the Hatch-Waxman Act, but overall preserved its legal and policy spirit of encouraging competition between the generic and brand-name drug industries. With this background in mind, it becomes straightforward to understand why the American Medical Association has officially issued clinical practice guidelines recommending the substitution of brand-name drugs with generic alternatives.

Below, we provide an in-depth interpretation and analysis of the clinical pharmacotherapy guideline article published online by the American College of Physicians in Annals of Internal Medicine. In recent years, there has been intense debate in the U.S. healthcare market regarding the relationship between high treatment costs and therapeutic efficacy. Is there a solution that can effectively ensure treatment outcomes while reducing costs? The answer is affirmative: the effective use of generic drugs serves as an excellent solution. The American College of Physicians comprehensively elucidates, from five perspectives, why the appropriate utilization of generic drugs can maintain favorable therapeutic outcomes while lowering treatment expenses. The content of these five aspects is summarized as follows:

1. How do clinicians typically use brand-name drugs when generic equivalents are available?

In recent years, although the utilization rate of generic drugs in the United States has effectively increased, the vast majority of U.S. healthcare institutions still prioritize recommending brand-name drugs when prescribing medications. For instance, in 2001, 40% of cardiovascular disease patients in the U.S. were prescribed brand-name drugs (specifically angiotensin-converting enzyme inhibitors and calcium channel blockers) rather than their less expensive generic counterparts. Similarly, in 2008, despite the availability of equivalent generic alternatives, 23% to 45% of diabetic patients received recommendations for brand-name prescriptions. This proportion is significantly higher than that observed within the U.S. Department of Veterans Affairs (VA) healthcare system, primarily because the VA system has established regulations promoting the use of generic drugs.

Widespread promotion and use of generic drugs can effectively reduce treatment costs. Data from a national survey on prescription medications in the United States showed that between 1997 and 2000, the use of generic drugs reduced medication costs by at least RMB 5.9 billion. Although this statistic was calculated based on the full list price of generic drugs, the savings in medication costs would be even greater if calculated using discounted generic drug prices. An unaudited survey report from 2009 indicated that for 20 classes of medications, substituting brand-name drugs with generics could save approximately RMB 329 billion annually in medication costs. Regarding the current state of treatment for common chronic diseases, physicians tend to prefer prescribing newer, relatively more expensive brand-name drugs when issuing prescriptions, even when clinical practice guidelines recommend alternative therapeutic options.

Thus, it is evident that there is a lack of corresponding regulations to govern when brand-name drugs should be used versus generic drugs. This current state of clinical medication practice has further prompted the American Medical Association to issue corresponding clinical medication guidelines.

2. How does the use of generic drugs affect patient medication adherence?

It is well known that high-priced brand-name drugs are closely associated with relatively low long-term medication adherence, as the majority of patients cannot afford the long-term use of brand-name medications. In a practical example, patients using brand-name drugs are twice as likely to discontinue treatment compared to those using generic drugs. From a clinical perspective, patients using affordable generic medications demonstrate better adherence and are more likely to follow long-term treatment recommendations, thereby achieving superior therapeutic outcomes. The reason is straightforward: long-term medication adherence is closely linked to lower out-of-pocket drug costs. The vast majority of clinical medication survey data support this conclusion. Clinician Shrank conducted a study on six classes of chronic disease medications and found that patients using generic drugs had an average medication adherence rate 6–7 percentage points higher than those using brand-name drugs.

In summary, the widespread clinical use of generic drugs has a positive effect on improving patients' medication adherence.

3. What clinical evidence demonstrates that generic drugs and brand-name drugs have similar clinical therapeutic effects?

It is well known that the U.S. Food and Drug Administration (FDA) maintains strict oversight over the market approval of new drugs. Generic drugs are likewise subject to rigorous FDA review and must meet all regulatory requirements before being approved for marketing. Most evidence provided by peer-reviewed studies supports the conclusion that generic drugs achieve clinical therapeutic effects equivalent to those of brand-name drugs. For instance, a statistical study covering nine categories of cardiovascular medications found that generic and brand-name drugs exhibited similar efficacy in anticoagulation and antiarrhythmic treatment. A research report by clinician Gagne indicated that the overall mortality rate among patients with acute coronary syndrome or stroke who were treated with generic drugs was approximately 8% lower than that among patients treated with brand-name drugs, further demonstrating that the clinical efficacy of generic drugs is acceptable. Admittedly, skepticism regarding the therapeutic effectiveness of generic drugs persists. Nevertheless, from an overall perspective, there is no significant difference in the clinical therapeutic effects between generic and brand-name drugs.

4. What are the barriers hindering the widespread use of generic drugs in clinical practice?

The current reality is that the frequency of generic drug use in clinical treatment is highly insufficient. There are two primary reasons for this: first, physicians’ personal biases lead them to prefer prescribing the newest brand-name drugs, which have higher visibility and higher prices; second, patients harbor certain concerns about generic drugs due to limited knowledge. These two factors constitute the main obstacles hindering the clinical promotion of generic drugs. A national medication survey in the United States found that the vast majority of Americans prefer brand-name drugs because they believe generics are less effective. Only about 36% of U.S. patients recognize the equivalence of generic drugs and proactively request them. The general perception among American citizens is that lower-priced medications are associated with lower efficacy, a subconscious belief that directly impedes the promotion of generics. Furthermore, approximately 25% of U.S. clinicians question the efficacy and safety of generic drugs and do not proactively prescribe them for disease treatment. More notably, pharmaceutical suppliers are also constrained by these biases held by patients and some physicians, creating invisible discrimination and barriers that further hinder the sales and promotion of generic drugs. In response to this awkward reality, the United States has enacted specific legislation to protect generic drugs. However, such laws can only affirm the legitimacy of generics; they cannot compel patients and physicians to use or promote them. Consequently, legal protections in this context have become remarkably ineffective.

5. What specific strategies can effectively reduce quality costs through the extensive use of generic drugs?

Although generic drugs offer therapeutic effects comparable to those of brand-name medications, how can we dispel the misconceptions arising from public unfamiliarity with them? Ensuring that affordable generic drugs better serve patients’ treatment needs has become a shared objective for many. The American Medical Association offers the following strategies:

First, regarding strategies for pharmaceutical suppliers. Actively adopting electronic health records (EHRs) to provide real-time regulatory notifications can remind physicians to promote affordable and effective generic drugs to patients. Relevant data indicate that this approach has effectively increased generic drug prescriptions by 3%. Furthermore, interrupting the use of new drug prescription tools launched by large academic medical centers can effectively boost generic drug prescriptions by approximately 20%. This is because academic medical centers tend to recommend the latest and most advanced brand-name drugs rather than generics, which can be somewhat misleading for both patients and physicians. Suppliers should break away from conventional thinking and proactively provide more free trial samples of generic drugs, which would positively help patients gain a deeper understanding of these medications. Meanwhile, brand-name drug manufacturers should be prohibited from engaging in illicit financial transactions with clinicians. This ensures that clinicians remain objective in recommending appropriate therapeutic agents for patients, rather than prescribing expensive brand-name drugs based on kickbacks.

Secondly, strategies targeted at patients themselves. Relevant research data indicate that once a patient has undergone treatment with generic drugs, their understanding and awareness of such medications typically deepen, while prior biases and skepticism are significantly reduced. This underscores the critical importance of conducting regular public welfare campaigns to promote guidelines for the use of generic drugs. These foundational educational initiatives enable patients to better comprehend the differences between generic and brand-name drugs, thereby facilitating more objective and proactive choices in therapeutic medications.

Finally, strategies targeting taxpayers and health insurance. In fact, taxpayers and national policymakers have long been striving to expand the use of generic drugs. It has been found that imposing medical financial penalties for the indiscriminate use of expensive brand-name drugs can effectively increase the frequency of generic drug utilization. Clear survey data already demonstrate that such financial penalty measures significantly enhance the efficiency of generic drug adoption and reduce national healthcare expenditures. The previously mentioned guidelines on generic drug use within the U.S. Veterans Health Administration system serve as a typical success story.

In summary, generic drugs are worth actively promoting and using due to their low cost and therapeutic efficacy comparable to that of brand-name drugs. We should promptly dispel the prevailing misconception that low-cost generic drugs are inferior in efficacy; there is no correlation between the two.

Translation: Chen Kun

Editor: Zhang Nan