HHS awarded $46.9M for biological product manufacturing, with a significant portion for Pennsylvania

Contract Overview

Contract Amount: $46,949,355 ($46.9M)

Contractor: Sanofi Vaccines US Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2004-09-30

End Date: 2010-09-24

Contract Duration: 2,185 days

Daily Burn Rate: $21.5K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COMBINATION (APPLIES TO AWARDS WHERE TWO OR MORE OF THE ABOVE APPLY)

Sector: Healthcare

Official Description: TAS::75 0140::TAS

Place of Performance

Location: SWIFTWATER, MONROE County, PENNSYLVANIA, 18370, UNITED STATES OF AMERICA

State: Pennsylvania Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $46.9 million to SANOFI VACCINES US INC. for work described as: TAS::75 0140::TAS Key points: 1. Contract value of $46.9 million over its duration. 2. Awarded by the Office of Assistant Secretary for Preparedness and Response (ASPR). 3. Focuses on Biological Product (except Diagnostic) Manufacturing. 4. Contract type is Full and Open Competition. 5. The award has a duration of 2185 days. 6. The contractor is SANOFI VACCINES US INC.

Value Assessment

Rating: fair

The total award amount of $46.9 million for biological product manufacturing over approximately six years suggests a moderate annual expenditure. Without specific deliverables or performance metrics, a direct value-for-money assessment is challenging. However, the duration of the contract implies a sustained need for these manufacturing capabilities. Benchmarking against similar long-term biological product manufacturing contracts would be necessary for a more precise valuation.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, indicating that multiple vendors had the opportunity to bid. The fact that it was competed openly suggests a competitive environment that should, in theory, lead to more favorable pricing and terms for the government. The number of bidders is not specified, which limits a deeper analysis of the competitive intensity.

Taxpayer Impact: Full and open competition generally benefits taxpayers by fostering a market where providers compete on price and quality, potentially leading to cost savings and better service delivery.

Public Impact

The primary beneficiary is the Department of Health and Human Services, specifically ASPR, in securing essential biological product manufacturing capabilities. The services delivered involve the manufacturing of biological products, crucial for public health preparedness and response. The contract has a specific geographic impact tied to the contractor's operations in Pennsylvania. Workforce implications include employment opportunities within the biological product manufacturing sector at the contractor's facility.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Lack of specific performance metrics makes it difficult to assess the contractor's track record and the effectiveness of the manufacturing process.
The long duration of the contract could lead to potential cost overruns if not managed effectively.
Dependence on a single contractor for critical biological product manufacturing could pose supply chain risks.

Positive Signals

Awarded under full and open competition, suggesting a competitive bidding process.
The contract addresses a critical need for biological product manufacturing, aligning with public health objectives.
The contractor, SANOFI VACCINES US INC., is a known entity in the pharmaceutical and vaccine industry.

Sector Analysis

This contract falls within the broader biopharmaceutical and life sciences sector, a critical area for national health security and economic development. The market for biological product manufacturing is substantial, driven by demand for vaccines, therapeutics, and other biological agents. This contract likely supports the government's strategic stockpile or ongoing public health initiatives, fitting within a landscape of significant federal investment in this sector.

Small Business Impact

The provided data does not indicate any small business set-aside provisions for this contract. Therefore, the direct impact on small businesses through this specific award is likely minimal, unless the prime contractor engages in subcontracting with small businesses. Further investigation into subcontracting plans would be needed to assess the broader impact on the small business ecosystem.

Oversight & Accountability

Oversight for this contract would typically be managed by the Department of Health and Human Services, likely through the Office of Assistant Secretary for Preparedness and Response (ASPR). Accountability measures would be defined in the contract's terms and conditions, including performance standards and reporting requirements. Transparency is generally facilitated through contract award databases, though detailed performance data may be less accessible.

Related Government Programs

Biologics and Vaccines
Public Health Preparedness
Medical Countermeasures
Pharmaceutical Manufacturing

Risk Flags

Potential for long-term dependency on a single manufacturer.
Lack of specific performance metrics in summary data.
Need for detailed review of contractor's past performance.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $46.9 million to SANOFI VACCINES US INC.. TAS::75 0140::TAS

Who is the contractor on this award?

The obligated recipient is SANOFI VACCINES US INC..

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 $46.9 million.

What is the period of performance?

Start: 2004-09-30. End: 2010-09-24.

What is the specific type of biological product being manufactured under this contract, and what is its intended use?

The contract specifies 'Biological Product (except Diagnostic) Manufacturing' but does not detail the specific product. Given the awarding agency (ASPR), it is highly probable that the products are related to public health preparedness, such as vaccines or therapeutics for potential pandemics, bioterrorism agents, or other national health emergencies. The exact nature of the product would require access to the detailed contract statement of work, which is not publicly available in this data extract. Understanding the specific product is crucial for assessing its criticality and the associated manufacturing risks and requirements.

How does the awarded amount of $46.9 million compare to historical spending on similar biological product manufacturing contracts by HHS or other agencies?

A direct comparison of the $46.9 million award requires identifying similar contracts for biological product manufacturing, considering factors like product type, volume, duration, and complexity. Without a detailed market analysis of comparable contracts, it's difficult to definitively state if this amount represents high, low, or average spending. However, for long-term manufacturing agreements supporting critical public health needs, this figure appears moderate. Agencies like BARDA (within HHS) and DoD often award substantial contracts for vaccine and therapeutic development and manufacturing, which can range from tens to hundreds of millions of dollars, depending on the program's scope and phase.

What are the key performance indicators (KPIs) or quality assurance measures stipulated in the contract to ensure the successful manufacturing of biological products?

The provided data does not include the specific Key Performance Indicators (KPIs) or quality assurance measures for this contract. Typically, contracts for biological product manufacturing would include stringent requirements related to Good Manufacturing Practices (GMP), product purity, potency, stability, and timely delivery. Performance would likely be monitored through regular reporting, site inspections, and adherence to predefined quality control protocols. The absence of this information in the summary data limits a thorough assessment of performance risk and contractor accountability.

What is the track record of SANOFI VACCINES US INC. in fulfilling government contracts, particularly for biological product manufacturing?

SANOFI VACCINES US INC. is a subsidiary of Sanofi, a major global pharmaceutical company with extensive experience in vaccine and drug development and manufacturing. While specific details on their government contract performance are not provided here, Sanofi has a history of engaging with government agencies, including HHS and DoD, for vaccine procurement and manufacturing initiatives, particularly during public health crises. Their established infrastructure and regulatory compliance experience suggest a capable contractor, but a comprehensive review would involve examining past performance evaluations and any reported issues on prior government contracts.

What is the potential impact of this contract on the domestic supply chain for critical biological products?

This contract contributes to the domestic supply chain by securing manufacturing capacity for specific biological products. By awarding this contract to SANOFI VACCINES US INC., the government ensures a dedicated or prioritized production capability, which can be crucial during times of high demand or national emergency. The impact on the broader supply chain depends on whether this contract supplements existing commercial production, represents new capacity, or involves specialized manufacturing processes. It reinforces the government's ability to access essential medical countermeasures and reduces reliance on potentially volatile international supply chains for these specific products.

Industry Classification

NAICS: Manufacturing › Pharmaceutical and Medicine Manufacturing › Biological Product (except Diagnostic) Manufacturing

Product/Service Code: MEDICAL/DENTAL/VETERINARY EQPT/SUPP

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Offers Received: 1

Pricing Type: COMBINATION (APPLIES TO AWARDS WHERE TWO OR MORE OF THE ABOVE APPLY) (2)

Evaluated Preference: NONE

Contractor Details

Parent Company: Sanofi Pasteur MSD SNC (UEI: 577272925)

Address: 1 DISCOVERY DR, SWIFTWATER, PA, 18370

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

Financial Breakdown

Contract Ceiling: $46,949,355

Exercised Options: $46,949,355

Current Obligation: $46,949,355

Timeline