Viewed in historical perspective, insulin prescriptions seem to have always shifted on to the next big thing before any competitive generic markets could take shape. The past decade could have witnessed a competitive marketplace of older insulins, except that it did not, as all prescriptions had shifted to recombinant human products, even though no compelling evidence had been provided that these agents result in better outcomes that the older products.
The problem of incremental innovation we describe—in which old drugs are only made available in unaffordable new packages—is not limited to insulin. Colchicine, a drug used to treat the ancient scourge of gouty arthritis since days of the ancient Greeks, was widely available as a generic drug for most of the 20th century—until it became limited to a brand-name monopoly controlled by the Philadelphia-based firm URL Pharma following an FDA decision in 2009.
Albuterol inhalers, first approved in 1968 and widely available from generic manufacturers in the 1980s, have long played a central role in the management of asthma. But as of December 2008, these essential drugs have only been available in brand-name forms as aparadoxical result of policies meant to protect the ozone layer. These are not examples of “orphan drugs” for the treatment of small populations of patients. All three of these drugs represent tried-and-true therapeutics for the management of common chronic diseases. And yet these old drugs have been made new—and newly unaffordable—for many of the patients who need them.
For decades, we have forged drug policy in the United States based on the assumption that generic competition will make all drugs affordable and accessible after their initial patents expire. In many cases, this “unbranding” process works just fine: generic products help Americans save billions of dollars per year compared to brand-name products. But as the case of insulin reminds us, many important generic markets can be iteratively “rebranded,” or fail to ever take shape in the first place.
As the U.S. Congress and the Department of Health and Human Services begin to investigate recent generic drug shortages and generic drug price-hikes, it is also crucial to explore the many ways that our assumptions about the relationship between brand-name and generic markets can falter. Much is still unknown about how generic drug markets take shape—and why they sometimes do not. We can and should do more to ensure access to affordable essential medicines for the American public.
Jeremy A. Greene, MD, PhD, is associate professor of medicine and the history of medicine at the Johns Hopkins University School of Medicine and is the author of Generic: The Unbranding of Modern Medicine.
Viewed in historical perspective, insulin prescriptions seem to have always shifted on to the next big thing before any competitive generic markets could take shape. The past decade could have witnessed a competitive marketplace of older insulins, except that it did not, as all prescriptions had shifted to recombinant human products, even though no compelling evidence had been provided that these agents result in better outcomes that the older products.The problem of incremental innovation we describe—in which old drugs are only made available in unaffordable new packages—is not limited to insulin. Colchicine, a drug used to treat the ancient scourge of gouty arthritis since days of the ancient Greeks, was widely available as a generic drug for most of the 20th century—until it became limited to a brand-name monopoly controlled by the Philadelphia-based firm URL Pharma following an FDA decision in 2009.Albuterol inhalers, first approved in 1968 and widely available from generic manufacturers in the 1980s, have long played a central role in the management of asthma. But as of December 2008, these essential drugs have only been available in brand-name forms as aparadoxical result of policies meant to protect the ozone layer. These are not examples of “orphan drugs” for the treatment of small populations of patients. All three of these drugs represent tried-and-true therapeutics for the management of common chronic diseases. And yet these old drugs have been made new—and newly unaffordable—for many of the patients who need them.For decades, we have forged drug policy in the United States based on the assumption that generic competition will make all drugs affordable and accessible after their initial patents expire. In many cases, this “unbranding” process works just fine: generic products help Americans save billions of dollars per year compared to brand-name products. But as the case of insulin reminds us, many important generic markets can be iteratively “rebranded,” or fail to ever take shape in the first place.As the U.S. Congress and the Department of Health and Human Services begin to investigate recent generic drug shortages and generic drug price-hikes, it is also crucial to explore the many ways that our assumptions about the relationship between brand-name and generic markets can falter. Much is still unknown about how generic drug markets take shape—and why they sometimes do not. We can and should do more to ensure access to affordable essential medicines for the American public.Jeremy A. Greene, MD, PhD, is associate professor of medicine and the history of medicine at the Johns Hopkins University School of Medicine and is the author of Generic: The Unbranding of Modern Medicine.
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