Product Hopping in the Drug Industry - Lessons from Albuterol
This NEJM article outlines the cautionary tale of how the development of more environmentally friendly albuterol inhalers impacted healthcare economics over the past 40 years. First approved in 1981, albuterol inhalers initially contained ozone-depleting chlorofluorocarbons (CFCs). Manufacturers subsequently developed greener hydrofluoroalkane (HFA) inhalers which were granted new patent clocks. In 2005, the FDA ruled that CFC inhalers, which had by then become inexpensive generics, would be phased out beginning in 2009. The resulting “product hops” to newer brand-name HFA albuterol inhalers led to expenditure of billions of healthcare dollars even though the new inhalers were therapeutically equivalent to older generics. The authors worry that, without patent and regulatory reform, this pattern is likely to be repeated. With even greener inhalers now in development, the authors propose various steps that policymakers could take to avoid another spending surge on inhalers and other therapeutics while still meeting environmental goals.