We study cartels that operated in the US generic drug industry, leveraging quarterly Medicaid data from 2011-2018 and a difference-in-differences approach comparing the evolution of prices of allegedly collusive drugs with a group of competitive control drugs. Our analysis highlights (i) the...

We study cartels that operated in the US generic drug industry, leveraging quarterly Medicaid data from 2011-2018 and a difference-in-differences approach comparing the evolution of prices of allegedly collusive drugs with a group of competitive control drugs. Our analysis highlights (i) the...

We compare the short-run welfare effects of two types of settlement agreements, quot;reverse paymentsquot; of the brand-name drug makers to generic producers not to enter the market and delayed entry when these payments are restricted both under the entry injunction (imposed by the Hatch-Waxman...

This paper explores the European Union (EU) regulatory regime for Traditional Chinese Médicine and its legal, cultural, economic , and international trade implications. The controversial Directive on Traditional Herbal Medicinal Products (THMPD) amended the European Community Code for medicinal...

Plastics convey enormous benefits to humankind, but current patterns of plastic production, use, and disposal with little attention to sustainable design and a near absence of recovery, reuse, and recycling are responsible for grave harms to health, great economic costs, and deep societal...

In 2010, President Obama signed into law the Biologics Price Competition and Innovation Act, which created an abbreviated approval pathway for competing versions of previously-approved biologics. Passage of this legislation and the impending introduction of follow-on biologics, or biosimilars,...

Under the Food and Drug Administration Amendments Act of 2007, the FDA can require the use of risk evaluation and mitigation strategies (REMS) over and above professional labeling, to ensure that a drug’s benefits outweigh its risks. The FTC and the generic drug industry have raised concerns...

Pharmaceutical products are developed, approved, manufactured, traded, and used under complex and demanding regulatory schemes. While the intensity of regulation varies substantially among countries, lightly regulated markets are the exception, particularly from an economic standpoint. In this...

Under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) all parties to the agreement are allowed flexibility in issuing licenses for manufacturing pharmaceutical drugs, in line with their public policy objectives. The licenses may be issued under certain conditions,...