HHS awards $98M contract to The Medicines Company for anti-infective program development through 2030

Contract Overview

Contract Amount: $98,144,230 ($98.1M)

Contractor: Medicines Company, the

Awarding Agency: Department of Health and Human Services

Start Date: 2016-09-15

End Date: 2030-09-30

Contract Duration: 5,128 days

Daily Burn Rate: $19.1K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST SHARING

Sector: R&D

Official Description: THE MEDICINE COMPANY - ADVANCE THE DEVELOPMENT OF A PORTFOLIO OF ANTI-INFECTIVE PROGRAMS. IGF::OT::IGF

Place of Performance

Location: PARSIPPANY, MORRIS County, NEW JERSEY, 07054

State: New Jersey Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $98.1 million to MEDICINES COMPANY, THE for work described as: THE MEDICINE COMPANY - ADVANCE THE DEVELOPMENT OF A PORTFOLIO OF ANTI-INFECTIVE PROGRAMS. IGF::OT::IGF Key points: 1. Contract focuses on advancing a portfolio of anti-infective programs, addressing critical public health needs. 2. Long-term award (2016-2030) suggests a strategic investment in a specific area of research and development. 3. The contract type is a definitive contract with cost-sharing, indicating shared risk and investment. 4. Research and Development in Biotechnology (NAICS 541711) is a highly specialized and crucial sector. 5. The award was made under full and open competition, suggesting a robust selection process. 6. The contractor, The Medicines Company, is positioned to deliver significant advancements in anti-infective therapies.

Value Assessment

Rating: good

The contract value of $98.14 million over its duration appears reasonable for advancing a portfolio of anti-infective programs, a complex and lengthy R&D process. Benchmarking against similar government investments in early-stage biotechnology development is challenging due to the proprietary nature of such research. However, the cost-sharing aspect suggests a commitment from the contractor, potentially indicating a fair valuation of the work. The long duration of the contract (over 13 years) also implies a phased approach to funding, which can be cost-effective for managing R&D expenditures.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, indicating that multiple qualified bidders had the opportunity to submit proposals. The specific number of bidders is not provided, but the competitive nature of the award process suggests that the government sought the best value and technical approach. This method generally leads to more competitive pricing and a wider range of innovative solutions being considered.

Taxpayer Impact: A full and open competition process is beneficial for taxpayers as it increases the likelihood of securing services at a competitive price and encourages innovation from a broad base of potential contractors.

Public Impact

The primary beneficiaries are public health, through the potential development of new anti-infective treatments to combat drug-resistant pathogens. The services delivered involve research and development activities aimed at advancing a portfolio of anti-infective programs. The geographic impact is primarily within New Jersey, where the contractor is located, but the ultimate impact of new medicines is global. Workforce implications include specialized jobs in biotechnology research and development within the contractor's organization.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Long contract duration (2016-2030) could lead to scope creep or evolving research needs that may impact final costs.
Reliance on a single contractor for a portfolio of critical anti-infectives may pose a risk if development faces significant setbacks.
Cost-sharing mechanisms require careful monitoring to ensure the contractor's contributions align with expectations.

Positive Signals

Awarded under full and open competition, suggesting a thorough evaluation of multiple proposals.
Focus on anti-infectives addresses a critical and growing public health concern (antimicrobial resistance).
Long-term commitment allows for sustained research and development, potentially leading to more robust outcomes.
Cost-sharing model aligns incentives between the government and the contractor.

Sector Analysis

The contract falls within the Biotechnology Research and Development sector, a critical area for public health and national security. This sector is characterized by high innovation, significant investment, and long development cycles. Government funding plays a vital role in de-risking early-stage research and encouraging the development of novel therapies, particularly for areas like anti-infectives where market incentives may be lower. Comparable spending benchmarks are difficult to establish due to the proprietary nature of R&D, but significant government investment in this area is common for addressing unmet medical needs.

Small Business Impact

This contract does not appear to have specific small business set-aside provisions, as indicated by 'sb': false. The primary contractor is 'THE MEDICINES COMPANY'. There is no explicit information regarding subcontracting plans for small businesses within the provided data. Therefore, the direct impact on the small business ecosystem is likely minimal unless the prime contractor voluntarily engages small businesses for specialized services.

Oversight & Accountability

Oversight for this contract would likely be managed by the Office of Assistant Secretary for Preparedness and Response (ASPR) within HHS. The definitive contract structure with cost-sharing implies regular reporting and milestone reviews. Accountability measures would be tied to the achievement of R&D milestones and the effective use of funds. Transparency is generally maintained through contract awards databases, though specific R&D progress details may be proprietary.

Related Government Programs

Biotechnology Research and Development
Public Health Preparedness
Antimicrobial Resistance Initiatives
Pharmaceutical Development Contracts

Risk Flags

Long-term R&D contract duration
Potential for scientific/technical failure in R&D
Market viability uncertainty for new drugs
Reliance on single contractor for portfolio development

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $98.1 million to MEDICINES COMPANY, THE. THE MEDICINE COMPANY - ADVANCE THE DEVELOPMENT OF A PORTFOLIO OF ANTI-INFECTIVE PROGRAMS. IGF::OT::IGF

Who is the contractor on this award?

The obligated recipient is MEDICINES COMPANY, THE.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Office of Assistant Secretary for Preparedness and Response).

What is the total obligated amount?

The obligated amount is $98.1 million.

What is the period of performance?

Start: 2016-09-15. End: 2030-09-30.

What is the track record of The Medicines Company in developing anti-infective programs funded by government contracts?

The provided data focuses on a single contract awarded in 2016. To assess The Medicines Company's track record, a broader review of their past performance, including previous government contracts, grants, and successful product development in the anti-infective space, would be necessary. Information on their pipeline, regulatory approvals, and commercialization of anti-infective drugs would offer further insight. Without this broader context, it's difficult to definitively assess their specific track record solely based on this award. However, securing a long-term, significant R&D contract from HHS suggests a level of confidence in their capabilities by the awarding agency.

How does the $98.14 million award compare to other federal investments in anti-infective R&D?

The $98.14 million award represents a substantial, long-term investment in a specific portfolio of anti-infective programs. Federal spending in anti-infective R&D is multifaceted, involving various agencies like NIH, BARDA (within ASPR), and DoD, often through grants, cooperative agreements, and contracts. While this specific award is significant for a single contractor's portfolio, overall federal investment in combating antimicrobial resistance (AMR) is in the billions annually, encompassing basic research, clinical trials, and advanced development. This contract likely represents a targeted investment within that larger federal strategy, focusing on advancing specific therapeutic candidates through later-stage development.

What are the primary risks associated with this contract, given its long duration and R&D focus?

The primary risks associated with this long-term R&D contract include scientific and technical risks (e.g., research failure, unexpected side effects, inability to meet efficacy targets), market risks (e.g., changes in disease prevalence, emergence of superior competing therapies), and financial risks (e.g., cost overruns, potential for the contractor to withdraw if commercial viability diminishes). The long duration (over 13 years) amplifies these risks, as the scientific and market landscapes can change significantly. Furthermore, the cost-sharing aspect requires careful monitoring to ensure the contractor's commitment remains strong throughout the project lifecycle. Regulatory hurdles and the complex path to drug approval also represent significant risks.

How effective is the cost-sharing mechanism in ensuring value for taxpayer money in this R&D contract?

The cost-sharing mechanism is designed to ensure value for taxpayer money by aligning the financial interests of the government and the contractor. By requiring The Medicines Company to contribute a portion of the R&D costs, the government incentivizes the contractor to manage resources efficiently and pursue scientifically and commercially viable outcomes. This shared risk can lead to more rigorous project management and a greater focus on achieving milestones. The effectiveness hinges on the specific cost-sharing ratio, the clarity of cost-sharing definitions, and robust oversight by HHS to verify the contractor's contributions and the overall progress towards program goals.

What are the historical spending patterns for anti-infective R&D by HHS or related agencies?

HHS, particularly through agencies like the Assistant Secretary for Preparedness and Response (ASPR) and the National Institutes of Health (NIH), has a history of significant investment in anti-infective R&D. Funding often targets areas of high unmet need, such as novel antibiotics, antivirals, and antifungals, especially those addressing drug-resistant pathogens. Historical spending patterns show a consistent, albeit fluctuating, commitment to combating infectious diseases and preparing for public health emergencies. This includes funding basic research, preclinical development, clinical trials, and advanced development through various mechanisms like grants, contracts, and public-private partnerships. The trend reflects a growing recognition of the threat posed by antimicrobial resistance (AMR).

What is the strategic importance of advancing a portfolio of anti-infective programs for public health preparedness?

Advancing a portfolio of anti-infective programs is strategically crucial for public health preparedness, particularly in the face of rising antimicrobial resistance (AMR). AMR threatens the effectiveness of modern medicine, making common infections potentially lethal and complicating procedures like surgery and chemotherapy. By investing in the development of new antibiotics, antivirals, and other anti-infectives, the government aims to ensure a robust pipeline of treatments to combat existing and emerging infectious threats. This contract supports the development of multiple candidates, increasing the likelihood of bringing at least one effective new therapy to market, thereby enhancing national and global health security and resilience against future pandemics or outbreaks.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology

Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: BAA16100SOL00001

Offers Received: 1

Pricing Type: COST SHARING (T)

Evaluated Preference: NONE

Contractor Details

Address: 8 SYLVAN WY, PARSIPPANY, NJ, 07054

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Manufacturer of Goods, Self-Certified Small Disadvantaged Business, Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $98,144,230

Exercised Options: $98,144,230

Current Obligation: $98,144,230

Actual Outlays: $45,407,752

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline