The abbreviated approval process authorized by Hatch-Waxman lets generic drug manufacturers use the same clinical data that the original manufacturer used to obtain FDA approval, thereby avoiding these expenses. In this regard, Greene emphasizes that, “Whereas the pioneer drug manufacturer must incur great expense and undergo rigorous scrutiny when it files an new drug application (NDA) to secure FDA approval, a generic manufacturer may file an Abbreviated New Drug Application (ANDA) in which it may take advantage of the NDA holders time and expense” (2005, p. 310).
The impact of the Hatch-Waxman Act on generic drug availability has been enormous. For instance, in 1984, generic drug prescriptions represented less than 20% of all prescription drugs marketed in the United States; however, due in large part to the Hatch-Waxman Act, by 1996, the market share for generic drugs had increased to 43% and by 2006, as many as 63% of all prescriptions in the United States were for generic equivalents (Kesselheim, 2006). Moreover, Abramson, Harrington, Missmar, Li and Mendelson (2004 note that, “Because of price caps from insurers on brand-name products, generic drug sales now constitute a principal source of operating revenue for most retail pharmacies” (p. 26). Given the proliferation of generic equivalents for name-brand drugs, a reasonable concern relates to whether these cheaper alternatives are as effective as their more expensive name-brand counterparts, and these issues are discussed further below.
Efficacy of Name-Brand Drugs vs. Generic Drugs
Critics of generic drugs point out that despite the fact that these medicines generally contain the same active ingredients as their name-brand counterparts, they do not always contain the same inactive ingredients which may produce different results in different healthcare consumers (Greene, 2005). Advocates of generic drugs counter that the studies to date have shown that these alternatives have “nearly always been shown to have identical therapeutic effects” (Kesselheim, 2008, p. 126). Similarly, Mossialos and his associates emphasize that, “A generic equivalent is a perfect substitute to the original brand and competes in price for market share” (p. 25). In order to qualify as a “perfect substitute,” generic drugs must satisfy rigorous quality and content standards. In this regard, Dr. Gary Buehler, director of the FDAs Office of Generic Drugs, advises, “A generic drug is a copy that is the same as a brand-name drug in dosage, safety, and strength, how it is taken, quality, performance, and intended use. Generic drugs are safe, effective and FDA-approved” (2002, p. 24). Moreover, Buehler (2002) insists that generic drugs work in the same fashion as their higher-priced name-brand counterparts and require the same amount of time to become effective. Critics, though, maintain that not only are some generic drugs prepared with different inactive ingredients that may affect their efficacy, manufacturers are being unduly enriched by taking advantage of the enormous costs that were incurred in the research and development of these brand-name drugs (Greene, 2005). Furthermore, although there remains a dearth of timely and relevant clinical studies concerning the respective efficacy of generic drugs compared to their name-brand alternatives, the research to date has shown that despite generic drugs being the chemically equivalent compound of a brand-name drug, “A a small number of patients in individual circumstances seem to fare better on a brand-name drug” (Fox, 2003, p. 7). Interestingly, though, the same body of research indicates that some patients appear to respond better to generic drugs compared to their higher-priced name-brand equivalents (Fox, 2003).
Beyond the foregoing considerations, there continue to be reports concerning the inferior quality of generic equivalents that not only affect their efficacy, but their safety for healthcare consumers as well. In this regard, Tobin (2009) recently reported that the European Union recalled a number of generic drugs manufactured by the Swiss pharmaceutical company Novartis because of “serious deficiencies” in administrative protocols and production methods. The generic equivalents subjected to the recall included a generic version of the antidepressant drug, Prozac, as well as various hypertension medications, diabetes medicine and analgesics (Tobin, 2009).
The research showed that generic drugs are becoming increasingly available as alternatives to their higher-priced name-brand equivalents due in large part to the passage of the Drug Price Competition and Patent Term Restoration Act of 1984 that paved the way for generic drug manufacturers to bring their versions of name-brand drugs to market more quickly. The research also showed that as much as half of the drugs being sold in the United States today are generic equivalents. Despite these trends, the research also showed that there are some barriers to access of more generic drug equivalents that prevent healthcare consumers from receiving generic equivalents in some cases, and there are concerns about the efficacy of generic drugs compared to their name-brand equivalents despite being chemically identical except for different inactive ingredients in some drugs. There have also been reports concerning the safety of these generic equivalents that have some healthcare consumers worried that these lower-priced medicines may not be as safe as their higher-priced alternatives. Despite these concerns, though, the FDA has been adamant in its assurances that the generic drugs marketed in the United States are as safe and effective as name-brand drugs. In the final analysis, the increasing need for medicines in the future will require more generic alternatives to help satisfy the demand among a rapidly aging population. No American should have to make the difficult choice between whether to spend money on the basic needs of life such as utilities, food and rent or the medicines needed to stay alive.
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