H.R.843 - Prompt Approval of Safe Generic Drugs Act (119th Congress)
Summary
H.R.843, the "Prompt Approval of Safe Generic Drugs Act," aims to amend the Federal Food, Drug, and Cosmetic Act to expedite the approval of generic drugs when safety information is added to their labeling. The bill addresses situations where safety information is protected by exclusivity or patent. It seeks to ensure that generic drugs can be approved even if they omit certain safety information protected by these measures, provided that the Secretary of Health and Human Services requires appropriate safety information to assure safe use.
Expected Effects
The bill is likely to increase the availability of generic drugs by reducing delays in their approval process. This could lead to lower drug prices and increased competition in the pharmaceutical market. The Secretary will have increased authority to require safety labeling.
Potential Benefits
- Increased availability of generic drugs.
- Potentially lower drug prices for consumers.
- Enhanced competition among drug manufacturers.
- Clearer guidelines for generic drug approval when safety information is involved.
- Secretary of Health and Human Services will have authority to require safety labeling.
Potential Disadvantages
- Potential for confusion or inconsistency in drug labeling if safety information is handled differently across brands.
- Risk that expedited approval could compromise thorough safety review, although the Secretary has authority to require safety labeling.
- Possible legal challenges from brand-name drug manufacturers regarding exclusivity and patent rights.
- The bill's impact on innovation in drug development is uncertain.
- May require additional resources for the FDA to implement the new approval process.
Constitutional Alignment
The bill appears to align with the Constitution's general welfare clause (Preamble). Congress has the power to regulate interstate commerce, which includes the regulation of drugs. The bill does not appear to infringe on any specific constitutional rights.
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).