Generic drug competition: The pharmaceutical industry “gaming” controversy

Among American adults 20 years and older, 59 percent take at least one prescription drug on a regular basis. Unlike most branded drugs, which are generally drugs that have a trade name and are protected by a patent, off‐patent generic drugs make up approximately 90 percent of prescriptions annually filled in the United States; yet in 2017, generic drugs made up only 23 percent of total drug costs in the U.S. The U.S. Food and Drug Administration has taken the lead in encouraging increased competition in the nation’s prescription drug marketplace, most recently with its release of the agency’s Drug Competition Action Plan, but also with its regulatory guidance and enforcement efforts to eliminate “gaming” of the regulatory process by both branded and generic pharmaceutical manufacturers. Such “gaming” activities include “pay‐for‐delay” agreements involving financial compensation between branded and generic pharmaceutical manufacturers to forestall the emergence into the market of generic pharmaceuticals to compete against a formerly patent‐protected branded drug. A combination of new enabling legislation, federal judicial guidance, and agency regulatory activities show promise in encouraging increased competition in the prescription drug marketplace, with the American consumer the ultimate beneficiary of lower health care costs and improved overall personal health.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/152498/1/basr12186_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/152498/2/basr12186.pd

Comparing generic drug markets in Europe and the United States: prices, volumes, and spending

Our study indicates that there are opportunities for cost savings in generic drug markets in Europe and the United States. Regulators should make it easier for generic drugs to reach the market. Regulators and payers should apply measures to stimulate price competition among generic drugmakers and to increase generic drug use. To meaningfully evaluate policy options, it is important to analyze historical context and understand why similar initiatives failed previously. Context: Rising drug prices are putting pressure on health care budgets. Policymakers are assessing how they can save money through generic drugs. Methods: We compared generic drug prices and market shares in 13 European countries, using data from 2013, to assess the amount of variation that exists between countries. To place these results in context, we reviewed evidence from recent studies on the prices and use of generics in Europe and the United States. We also surveyed peer‐reviewed studies, gray literature, and books published since 2000 to (1) outline existing generic drug policies in European countries and the United States; (2) identify ways to increase generic drug use and to promote price competition among generic drug companies; and (3) explore barriers to implementing reform of generic drug policies, using a historical example from the United States as a case study. Findings: The prices and market shares of generics vary widely across Europe. For example, prices charged by manufacturers in Switzerland are, on average, more than 2.5 times those in Germany and more than 6 times those in the United Kingdom, based on the results of a commonly used price index. The proportion of prescriptions filled with generics ranges from 17% in Switzerland to 83% in the United Kingdom. By comparison, the United States has historically had low generic drug prices and high rates of generic drug use (84% in 2013), but has in recent years experienced sharp price increases for some off‐patent products. There are policy solutions to address issues in Europe and the United States, such as streamlining the generic drug approval process and requiring generic prescribing and substitution where such policies are not yet in place. The history of substitution laws in the United States provides insights into the economic, political, and cultural issues influencing the adoption of generic drug policies. Conclusions: Governments should apply coherent supply‐ and demand‐side policies in generic drug markets. An immediate priority is to convince more physicians, pharmacists, and patients that generic drugs are bioequivalent to branded products. Special‐interest groups continue to obstruct reform in Europe and the United States

Obesity and the food system transformation in Latin America

The Latin America and the Caribbean (LAC) region faces a major diet-related health problem accompanied by enormous economic and social costs. The shifts in diet are profound: major shifts in intake of less-healthful low-nutrient-density foods and sugary beverages, changes in away-from-home eating and snacking and rapid shifts towards very high levels of overweight and obesity among all ages along with, in some countries, high burdens of stunting. Diet changes have occurred in parallel to, and in two-way causality with, changes in the broad food system – the set of supply chains from farms, through midstream segments of processing, wholesale and logistics, to downstream segments of retail and food service (restaurants and fast food chains). An essential contribution of this piece is to marry and integrate the nutrition transition literature with the literature on the economics of food system transformation. These two literatures and debates have been to date largely ‘two ships passing in the night’. This review documents in-depth the recent history of rapid growth and transformation of that broad food system in LAC, with the rapid rise of supermarkets, large processors, fast food chains and food logistics firms. The transformation is the story of a ‘double-edged sword’, showing its links to various negative diet side trends, e.g. the rise of consumption of fast food and highly processed food, as well as in parallel, to various positive trends, e.g. the reduction of the cost of food, de-seasonalization, increase of convenience of food preparation reducing women's time associated with that and increase of availability of some nutritious foods like meat and dairy. We view the transformation of the food system, as well as certain aspects of diet change linked to long-run changes in employment and demographics (e.g. the quest for convenience), as broad parameters that will endure for the next decades without truly major regulatory and fiscal changes. We then focus in on what are the steps that are being and can be taken to curb the negative effects on diet of these changes. We show that countries in LAC are already among the global leaders in initiating demand-related solutions via taxation and marketing controls. But we also show that this is only a small step forward. To shift LAC's food supply towards prices that incentivize consumption of healthier diets and demand away from the less healthy component is not simple and will not happen immediately. We must be cognizant that ultimately, food industry firms must be incentivized to market the components of healthy diets. This will primarily need to be via selective taxes and subsidies, marketing controls, as well as food quality regulations, consumer education and, in the medium term, consumers' desires to combine healthier foods with their ongoing quest for convenience in the face of busy lives. In the end, the food industry in LAC will orient itself towards profitable solutions, ie those demanded by the broad mass of consumers