Overview

Title

To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.

ELI5 AI

This bill wants to make the waiting time the same before starting talks about how much certain medicines should cost, so both tiny and big medicines have to wait at least 11 years before any price talks can begin. This change is meant to help make new medicines while controlling how much they cost.

Summary AI

S. 832 aims to amend the Social Security Act to make the negotiation period for drug prices the same for both small-molecule drugs and biologic drugs. The bill would change the initial applicability year so that starting in 2028, there is an extended period, at least 11 years, from drug approval to when price negotiations can start. This change is intended to encourage the development of innovative drugs while managing their costs under the Drug Price Negotiation Program.

Published

2025-03-04
Congress: 119
Session: 1
Chamber: SENATE
Status: Introduced in Senate
Date: 2025-03-04
Package ID: BILLS-119s832is

Keywords AI

social security act amendment drug price negotiation program biologic drugs small-molecule drugs negotiation period extension drug pricing 2028 implementation innovative drug development epic act of 2025 s. 832 bill

Sources

Bill Statistics

Size

Sections:
2
Words:
248
Pages:
2
Sentences:
7

Language

Nouns: 84
Verbs: 16
Adjectives: 8
Adverbs: 2
Numbers: 11
Entities: 27

Complexity

Average Token Length:
4.15
Average Sentence Length:
35.43
Token Entropy:
4.42
Readability (ARI):
19.00

AnalysisAI

General Summary of the Bill

The legislation titled the Ensuring Pathways to Innovative Cures Act of 2025, also known as the EPIC Act of 2025, proposes an amendment to title XI of the Social Security Act. The primary goal of this bill is to adjust the negotiation periods within the Drug Price Negotiation Program, specifically concerning small-molecule and biologic drugs. Currently, there is a specified negotiation period after which the prices of drugs can be negotiated. For the years 2026 and 2027, the bill maintains a minimum period of 7 years after drug approval before negotiation can begin. However, starting in 2028, this period is proposed to extend to at least 11 years.

Summary of Significant Issues

Several issues are notable in the proposal of this bill:

  1. Differentiation Between Time Periods: The bill stipulates different negotiation periods for different years (2026 and 2027 versus 2028 and onwards). It lacks an explanation for why a change is necessary or beneficial, which could lead to confusion.

  2. Lack of Justification: Increasing the waiting period from 7 to 11 years for biologic drugs starting in 2028 is a substantial change that the bill does not justify. For those impacted by drug pricing, understanding the rationale behind this lengthened period is crucial.

  3. Impact on Drug Pricing and Accessibility: The bill does not address how these changes could influence drug prices and accessibility. This omission is critical as it affects patients' affordability and availability of necessary medications.

  4. Implication on Contracts: The bill does not clarify how existing and future contracts will accommodate these changes, which might significantly impact all parties involved in drug pricing negotiations.

  5. Complex Legal Language: The bill's legalistic language could hinder understanding for those unfamiliar with legislative documents, thus potentially alienating the general public from engaging in dialogue about these changes.

Impact on the Public and Stakeholders

Broad Public Impact:

The public might encounter delays in accessing more affordable medications due to the extended negotiation period for biologic drugs. The lack of clarity in the legislation may result in misunderstandings about drug pricing changes and their timeline.

Specific Stakeholder Impact:

  • Pharmaceutical Companies: Companies developing biologic drugs may benefit from an extended period of market exclusivity before price negotiations can start. This could serve as an incentive for continued investment in drug development.

  • Patients and Healthcare Providers: These groups might face challenges with drug affordability if price negotiations are delayed, potentially influencing treatment options. Providers may have to navigate increased drug costs by adjusting prescriptions, which could impact patient care.

  • Insurance Companies and Government Programs: These entities might need to brace for higher drug expenditure over the extended exclusivity period, which could influence premium costs and healthcare budgets.

Overall, while the bill aims to equalize negotiation periods by amending existing legislation, it inadvertently raises several concerns about its implementation and justification, affecting various stakeholders differently. The absence of clear reasoning and the potential economic implications require thorough examination and dialogue to ensure fair and beneficial outcomes for all involved.

Issues

  • The amendment lacks an explanation for why the negotiation period is different for 2026 and 2027 compared to subsequent years, which could lead to confusion and may affect stakeholders' understanding of the bill's intentions. (Section 2)

  • The bill changes the negotiation period from at least 7 years to at least 11 years for biologic candidates starting from 2028 without providing a rationale, which could be confusing and may need justification. The lack of explanation could lead to concerns about the bill's impact. (Section 2)

  • There is no discussion of the amendment's impact on drug pricing and accessibility, particularly for small-molecule versus biologic candidates, which could be a significant concern for stakeholders and the general public. (Section 2)

  • The amendment does not mention how the extension of the negotiation period will affect current and future contracts, which might be crucial for planning purposes and for parties involved in the Drug Price Negotiation Program. (Section 2)

  • The document uses legal language that may be complex for individuals not familiar with legislative or legal terminology, potentially making it difficult for the general public to understand the implications of the bill. (Section 2)

Sections

Sections are presented as they are annotated in the original legislative text. Any missing headers, numbers, or non-consecutive order is due to the original text.

1. Short title Read Opens in new tab

Summary AI

The first section of the Act states its official titles, which are the “Ensuring Pathways to Innovative Cures Act of 2025” and the “EPIC Act of 2025”.

2. Equalizing the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program Read Opens in new tab

Summary AI

The section modifies the Drug Price Negotiation Program by amending the Social Security Act to change the negotiation period for drug prices. Starting in 2028, drugs must have been approved for at least 11 years before their prices can be negotiated, compared to at least 7 years for the years 2026 and 2027.