Format

Send to

Choose Destination
Health Aff (Millwood). 2018 May;37(5):732-737. doi: 10.1377/hlthaff.2017.1179.

Evaluating The Impact Of The Orphan Drug Act's Seven-Year Market Exclusivity Period.

Author information

1
Ameet Sarpatwari ( asarpatwari@bwh.harvard.edu ) is an instructor of medicine at Harvard Medical School and assistant director of the Program on Regulation, Therapeutics, and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital, both in Boston, Massachusetts.
2
Reed F. Beall is a postdoctoral fellow in the Program on Regulation, Therapeutics, and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital and a research fellow at Harvard Medical School.
3
Abdurrahman Abdurrob is a research assistant at Brigham and Women's Hospital.
4
Mengdong He is a research scientist at Brigham and Women's Hospital.
5
Aaron S. Kesselheim is an associate professor of medicine at Harvard Medical School and director of the Program on Regulation, Therapeutics, and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital.

Abstract

For thirty-five years the Orphan Drug Act of 1983 has provided incentives for pharmaceutical manufacturers to develop drugs to treat rare diseases-conditions that affect fewer than 200,000 people in the US. One key statutory incentive is an exclusive seven-year marketing right for the rare disease indication, which has been heralded as driving a dramatic increase in the number of rare disease treatments. However, most new drugs are also protected by patents. In this study we assessed all new small-molecule drugs approved in the period 1985-2014 that had at least one indication for an orphan-designated disease as of January 1, 2017. We found that orphan drug exclusivity outlasted the last expiring patent in 33 percent of cases overall, and in a smaller percentage of cases for each successive ten-year drug cohort: from 50 percent for drugs approved in 1985-94 to 35 percent for those approved in 1995-2004 and 18 percent for those approved in 2005-14. The Orphan Drug Act's market exclusivity incentive has played an increasingly smaller role in protecting rare disease drugs from competition, while rare disease drugs have substantially increased as a fraction of all new drug approvals.

KEYWORDS:

Pharmaceuticals

PMID:
29733729
DOI:
10.1377/hlthaff.2017.1179

Supplemental Content

Full text links

Icon for Atypon
Loading ...
Support Center