Texas A&M Law Review

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This Comment examines the extent to which Congress empowered the FDA to address the increase in petitions and the general accessibility of orphan drug remedies. Specifically, this Comment seeks to understand why the FDA’s interpretation of the purpose of the ODA seems to conflict with the statutory intent as interpreted by federal courts. This Comment considers a statute’s ultimate goal or social purpose to be the purpose of the statute, whereas the express mechanisms by which Congress seeks to bring about these goals is best understood as the statute’s intent. To understand the FDA and judiciary’s differing interpretations of the ODA, this Comment analyzes the language of the Statute, recent ODA litigation, FDA’s promulgated regulations, as well as recent response to pharmaceutical companies’ increase in designation requests for orphan drugs.

Ultimately, this Comment strives to determine whether or not the ODA can effectively achieve the goals Congress set forth in 1983.This Comment conducts a statutory analysis of the ODA and closely examines how courts, the FDA, and litigant pharmaceutical companies interpret the Statute differently. This Comment argues that Congress’s intent in passing the ODA was to create lucrative incentives for the development of drugs for orphan diseases. But, Congress’s purpose in drafting the ODA was to ensure the drugs became available to patients. The incentives serve as a tool to achieve the purpose of the ODA: to treat patients suffering from rare diseases.This Comment concludes that to better effectuate this purpose, Congress must amend the ODA or pass other legislation empowering the FDA to promulgate regulations that alter the schedule and administration of the ODA’s lucrative “basket of goodies.”



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