alexa The benefits from giving makers of conventional 'small molecule' drugs longer exclusivity over clinical trial data.
Nursing & Health Care

Nursing & Health Care

Health Economics & Outcome Research: Open Access

Author(s): Goldman DP, Lakdawalla DN, Malkin JD, Romley J, Philipson T

Abstract Share this page

Abstract Pharmaceutical companies and generic drug manufacturers have long been at odds over "data exclusivity" regulations. These rules require a waiting period of at least five years before generic drug companies can access valuable clinical trial data necessary to bring less expensive forms of innovative drugs to market. Pharmaceutical companies want the data exclusivity period lengthened to protect their investment. Generic manufacturers want the period shortened so that they can bring less expensive versions of drugs to patients sooner. We examine the long-term effect of extending the data exclusivity period for conventional "small-molecule" drugs to twelve years--the same exclusivity period already extended to large-molecule biologic drugs under the Affordable Care Act. We conclude that Americans would benefit from a longer period of data exclusivity.
This article was published in Health Aff (Millwood) and referenced in Health Economics & Outcome Research: Open Access

Relevant Expert PPTs

Relevant Speaker PPTs

Recommended Conferences

Relevant Topics

Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

 
© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
adwords