Mikaela Naylon Give Kids a Chance Act
Summary
The Mikaela Naylon Give Kids a Chance Act focuses on amending the Federal Food, Drug, and Cosmetic Act to improve pediatric cancer research and drug development. It addresses molecularly targeted pediatric cancer investigations, completion of pediatric study requirements, and the extension of priority review vouchers for rare pediatric diseases. The act also includes provisions for transparency in generic drug applications and the establishment of an Abraham Accords Office within the FDA.
Expected Effects
This act aims to accelerate the development of treatments for pediatric cancers and rare diseases. It will likely lead to increased research into pediatric uses of drugs and greater transparency in the drug approval process. The establishment of the Abraham Accords Office may foster international cooperation in drug regulation.
Potential Benefits
- Enhanced research into pediatric cancer treatments.
- Increased transparency in generic drug applications.
- Extension of priority review vouchers to encourage treatments for rare pediatric diseases.
- Improved completion rates of required pediatric studies.
- Potential for international collaboration through the Abraham Accords Office.
Potential Disadvantages
- Potential for increased costs associated with drug development, which could impact drug pricing.
- The Abraham Accords Office may create additional bureaucratic layers within the FDA.
- Some provisions may take several years to fully implement, delaying immediate benefits.
- The sunset clause on registration fees for organ transplantation could create uncertainty.
- The act's focus on specific areas may divert resources from other important public health initiatives.
Constitutional Alignment
The act primarily aligns with the Commerce Clause (Article I, Section 8) by regulating drug development and interstate commerce related to pharmaceuticals. It also aligns with the General Welfare Clause (Preamble) by promoting public health through improved treatments for pediatric diseases. The establishment of the Abraham Accords Office could be seen as an exercise of the President's power to conduct foreign affairs, although this is implemented through the FDA.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).