Investment Incentives Created by the Montreal Protocol and FDA Policy on Albuterol
20 November 2003
By Dr. Richard Rozek et al.
The Montreal Protocol, an international agreement to improve the global environment, creates incentives for companies to invest resources in R&D to find alternative technologies that do not cause environmental harm. With respect to pharmaceuticals, two companies developed albuterol products using patented non-ozone-depleting metered-dose inhalers that have been approved for patients with asthma and COPD. Given that these alternatives exist, the US Food and Drug Administration (FDA) is following the lead of other countries by considering whether to eliminate albuterol products with ozone-depleting propellants. This article analyzes the economic impact on patients and third-party payers of such a policy change. The authors determine that patients will continue to be adequately served. Moreover, the structure of the market-place is likely to become more competitive after the policy change.
This article is based on Comments the authors filed with the FDA on 9 September 2003.
This article was published in the Vol. 6, No. 6, November 2003 issue of The Journal of World Intellectual Property and is posted with the permission of the publisher.
