The Benefits From Giving Makers Of Conventional ‘Small Molecule’ Drugs Longer Exclusivity Over Clinical Trial Data

Abstract

Pharmaceutical companies and generic drug manufacturers have long been at odds over “data exclusivity” regulations. These rules require a waiting period of up to eight 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 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.

The Evolution of the Pharmaceutical Industry Over the Past 50 Years: A Personal Reflection

“…The longer data exclusivity for biological entities could further tilt R&D incentives away from new chemical entities, especially given the increased uncertainty associated with early life cycle Hatch-Waxman patent challenges. A recent paper investigates the societal benefits and costs from extending a 12-year data exclusivity time to small molecular drugs (Goldman et al, 2011). Using a simulation model, they found that Americans would benefit over the long term from the resulting increased innovation and longer expected longevity for individuals.…”

Pharmaceutical innovation and non-patent protection

“…A study published in January 2011 was the first to calculate the financial and social costs of limiting access to trial data. This study found that although extending the term of exclusive access would lead to higher drug costs in the short term, it would also generate more than 200 extra drug approvals in the US and greater life expectancy over the next several decades [12].…”

Intellectual Property, Information Technology, Biomedical Research, and Marketing of Patented Products

“…Specifically, data exclusivity in the pharmaceutical industry refers to the period of time after approval of a new chemical entity before a generic manufacturer can use the proprietary safety and efficacy data that were submitted during the original approval process in seeking marketing approval (Goldman et al, 2011). Given the high cost of conducting clinical trials, data exclusivity makes it costly for competitors to enter, even though they technically can choose to conduct their own clinical trials and seek approval on the basis of their own studies.…”