H.R.1843 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. (119th Congress)
Summary
H.R.1843 aims to amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. The bill requires the Secretary of Health and Human Services to provide information to generic drug applicants regarding the qualitative and quantitative sameness of their drug to the listed drug. This includes disclosing any differences in ingredients and their amounts.
The bill also mandates the Secretary to issue guidance on determining whether a drug is qualitatively and quantitatively the same as the listed drug, including assessing pH adjusters. The changes apply immediately upon enactment, regardless of when the guidance is finalized.
Expected Effects
The bill will likely lead to greater clarity and predictability in the generic drug approval process. This could reduce the time and cost associated with developing and approving generic drugs. It may also foster more competition in the pharmaceutical market.
Increased transparency could also help to prevent the approval of generic drugs that are not truly equivalent to their brand-name counterparts. This could improve patient safety and ensure that patients receive the intended therapeutic benefits.
Potential Benefits
- Increased transparency: Generic drug applicants will have more information about the requirements for approval.
- Reduced costs: The streamlined approval process could lower the cost of developing generic drugs, potentially leading to lower drug prices for consumers.
- Improved patient safety: Ensuring that generic drugs are qualitatively and quantitatively the same as the listed drug could improve patient safety.
- Greater competition: More clarity in the approval process could encourage more companies to develop generic drugs, increasing competition.
- Faster approval times: The bill aims to streamline the approval process, potentially leading to faster access to generic drugs for patients.
Potential Disadvantages
- Increased administrative burden: The FDA may face an increased workload in providing the required information to generic drug applicants.
- Potential for delays: The guidance development process could potentially delay the implementation of the bill's provisions.
- Unintended consequences: The specific requirements of the bill could have unintended consequences that are not immediately apparent.
- Possible litigation: Disputes over the interpretation of the bill's provisions could lead to litigation.
Constitutional Alignment
The bill appears to align with the Commerce Clause (Article I, Section 8, Clause 3) of the US Constitution, as it regulates the production and distribution of drugs, which falls under interstate commerce. The bill does not appear to infringe upon any individual liberties or rights protected by the Bill of Rights.
Furthermore, the bill's focus on transparency and patient safety aligns with the general welfare clause of the Constitution's preamble, which aims to "promote the general Welfare."
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).