Reforming Evergreening and Manipulation that Extends Drug Years Act; REMEDY Act
Summary
The REMEDY Act aims to amend the Federal Food, Drug, and Cosmetic Act regarding the approval of abbreviated new drug applications (ANDAs). It targets practices known as "evergreening," where pharmaceutical companies extend drug patents to maintain market exclusivity. The bill seeks to limit the ability of drug manufacturers to file multiple patents on a single drug and then strategically select which patent will be subject to a 30-month stay upon an ANDA challenge.
Expected Effects
The primary effect of the REMEDY Act would be to streamline the process for generic drug manufacturers to enter the market. By limiting the patent selection for the 30-month stay, the bill intends to reduce delays and costs associated with patent litigation. This could lead to lower drug prices for consumers and increased competition in the pharmaceutical industry.
Potential Benefits
- Potentially lower drug prices for consumers due to increased generic competition.
- Reduced healthcare costs for individuals and the government.
- Streamlined ANDA approval process, making generic drugs available sooner.
- Discourages pharmaceutical companies from using patent strategies to extend monopolies.
- Encourages innovation by reducing the profitability of extending existing patents.
Potential Disadvantages
- May reduce the profitability of pharmaceutical companies, potentially impacting investment in new drug development.
- Could lead to increased litigation as companies seek to challenge the "covered patent" selection.
- The selection of a single "covered patent" may create loopholes or unintended consequences.
- The bill's effectiveness depends on how the FDA interprets and implements the new provisions.
- Potential for pharmaceutical companies to shift strategies to circumvent the intent of the law.
Constitutional Alignment
The REMEDY Act appears to align with the Constitution's intent to promote the general welfare (Preamble). Congress has the power to regulate interstate commerce (Article I, Section 8), which includes the regulation of pharmaceuticals and patents. The Act does not appear to infringe on individual rights or freedoms protected by the Bill of 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).