Summary of Bill S 1214
The RARE Act, also known as Bill 118 s 1214, is a piece of legislation currently being considered by the US Congress. The purpose of this bill is to address the issue of rare diseases, which are defined as conditions that affect fewer than 200,000 people in the United States.
The RARE Act aims to improve research, treatment, and support for individuals with rare diseases by establishing a Rare Disease Center of Excellence within the National Institutes of Health (NIH). This center would be responsible for coordinating research efforts, providing resources for healthcare providers, and promoting collaboration among stakeholders in the rare disease community.
Additionally, the RARE Act seeks to enhance the collection and analysis of data related to rare diseases by expanding the Rare Diseases Clinical Research Network and creating a Rare Disease Patient Registry. These initiatives would help to improve our understanding of rare diseases and facilitate the development of new treatments and therapies.
Overall, the RARE Act is a bipartisan effort to address the unique challenges faced by individuals with rare diseases and to promote innovation in the field of rare disease research. If passed, this legislation has the potential to make a significant impact on the lives of those affected by rare diseases in the United States.
Congressional Summary of S 1214
Retaining Access and Restoring Exclusivity Act or the RARE Act
This bill specifies that the seven-year market exclusivity period for drugs for rare diseases or conditions (i.e., orphan drug exclusivity period) prohibits the approval of the same drug for the same approved use or indication with respect to the disease or condition.
Current law grants a seven-year period of market exclusivity for an approved orphan drug, during which the Food and Drug Administration (FDA) may not approve an application from another manufacturer for the same drug for the same disease or condition. The FDA's regulations provide that this exclusivity is specific to the same approved use or indication of the drug, rather than all uses or indications, for the disease or condition. However, in Catalyst Pharmaceuticals, Inc. v. Becerra, a court held that exclusivity did extend to all uses or indications for the disease or condition.
The bill provides statutory authority for the FDA's regulations.