American Pharmaceutical Access: A System that is not Designed for Patients

The price of prescription drugs in the United States is often one of the highest on the globe. As such, health care access in the United States is difficult for those without a good private insurance plan. Focusing on the United States, this paper will highlight the issues in the United States that acts as a barrier to entry of both generics and biologics. In order to do this, the paper will focus on intellectual property rights, particularly patent monopoly and regulatory exclusivities that are provided by the US Food & Drug Administration. At the outset, the paper will discuss the issues with generic drugs in the United States. In order to do so, the paper will focus on the evergreening and how pharmaceutical companies extend the life of a patent beyond the term in order to extend the monopoly hold over the market. In order to demonstrate this, the paper will take Insulin, the diabetic medication as an example. The paper will then discuss some suggestions to minimize evergreening for both the patent regime as well as the regulatory regime. Next, the paper will contrast the presence of biosimilars in Europe with United States. Taking the biologic drug Humira as an example, this section will discuss all the barriers to timely entry of biosimilars including the use of terminal disclosures and patent hopping. The paper will provide suggestions for the development of a robust biosimilars regime under the Inflation Reduction Act, 2023. Given the controversies involved with access to health-care in the United States, especially in the post-pandemic world, the paper is timely not just in dealing with a critical issue but also in analysing the role of the Inflation Reduction Act, 2023 to enable health care access in the United States.