H.R.1051 - To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. (119th Congress)
Summary
H.R.1051 aims to amend the Federal Food, Drug, and Cosmetic Act concerning the approval process for generic drugs. Specifically, it addresses situations where the first applicant for a generic drug fails to bring their product to market within a defined timeframe. The bill seeks to allow subsequent applicants to gain approval despite the first applicant's exclusivity period, under certain conditions.
Expected Effects
This bill could lead to quicker availability of generic drugs by preventing delays caused by first applicants who do not commercialize their products promptly. This could foster greater competition in the pharmaceutical market. Ultimately, this may result in lower drug prices for consumers.
Potential Benefits
- Increased availability of generic drugs.
- Potential for lower drug prices due to increased competition.
- Discourages delays in bringing generic drugs to market.
- Provides a pathway for subsequent applicants to enter the market.
- May incentivize first applicants to commercialize their products more quickly.
Potential Disadvantages
- May reduce the incentive for companies to be the first to file a generic drug application, potentially slowing down the initial wave of generic drug development.
- Could lead to legal challenges and disputes over exclusivity rights.
- May create uncertainty in the generic drug approval process.
- Could negatively impact the profitability of first generic applicants.
- Potential for unintended consequences in the pharmaceutical market.
Constitutional Alignment
The bill appears to align with the general welfare clause of the Constitution, as it aims to promote access to affordable medications. Congress has the power to regulate interstate commerce, which includes the pharmaceutical industry, under Article I, Section 8. The bill does not appear to infringe on any specific constitutional rights or freedoms.
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).