HHS awards $59M for Leukine injections, a critical biodefense medication, under full and open competition

Contract Overview

Contract Amount: $59,026,989 ($59.0M)

Contractor: Partner Therapeutics, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2022-07-25

End Date: 2024-03-29

Contract Duration: 613 days

Daily Burn Rate: $96.3K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: LEUKINE 250MCG/VIL INJ

Place of Performance

Location: BOSTON, SUFFOLK County, MASSACHUSETTS, 02210

State: Massachusetts Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $59.0 million to PARTNER THERAPEUTICS, INC. for work described as: LEUKINE 250MCG/VIL INJ Key points: 1. The contract supports the strategic national stockpile with a vital biodefense medication. 2. Pricing appears competitive given the specialized nature of the pharmaceutical product. 3. The contract duration of over 600 days suggests a sustained need for the medication. 4. The award was made under a broad indefinite-delivery/indefinite-quantity contract vehicle. 5. This award is part of a larger effort to maintain readiness for public health emergencies. 6. The fixed-price contract type helps mitigate cost overrun risks for the government.

Value Assessment

Rating: good

The awarded amount of $59,026,989.30 for Leukine injections appears reasonable for a critical biodefense medication procured by the Department of Health and Human Services. While direct comparisons are difficult without specific volume data, the fixed-price nature of the contract provides cost certainty. The contract was awarded under an existing IDIQ vehicle, suggesting that pricing was likely benchmarked against previously negotiated rates or market analysis conducted during the establishment of that vehicle. The value proposition lies in ensuring the availability of a life-saving drug for national health security.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, indicating that all responsible sources were permitted to submit offers. The specific IDIQ vehicle under which this delivery order was placed likely underwent a competitive process itself. The existence of full and open competition generally promotes price discovery and allows the government to solicit the best value from a wide range of potential suppliers, leading to potentially more favorable pricing and terms.

Taxpayer Impact: Taxpayers benefit from the competitive process through potentially lower prices and access to a broader range of qualified suppliers, ensuring the government obtains the best value for essential medical supplies.

Public Impact

The primary beneficiaries are the American public, who are protected by the strategic national stockpile's readiness. The service delivered is the provision of Leukine (sargramostim), a medication used to treat certain types of damage to the bone marrow caused by chemotherapy or radiation therapy. The geographic impact is national, ensuring availability across the United States in the event of a public health emergency. The contract supports the pharmaceutical manufacturing sector and ensures the availability of critical medical countermeasures.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for supply chain disruptions impacting delivery timelines for a critical medication.
Reliance on a single manufacturer for a specific formulation could pose risks if production is interrupted.
Ensuring adequate inventory levels are maintained to meet unpredictable demand during emergencies.

Positive Signals

Awarded under a full and open competition, suggesting a robust supplier pool.
Fixed-price contract type limits the government's exposure to cost increases.
The contract supports the strategic national stockpile, a key component of national biodefense.
The medication is critical for treating bone marrow damage, a significant public health concern.

Sector Analysis

The pharmaceutical preparation manufacturing sector is highly regulated and characterized by significant research and development costs, stringent quality control, and complex supply chains. This contract falls within the broader healthcare and life sciences industry, specifically focusing on biodefense and emergency preparedness. Spending in this area is often driven by government initiatives to maintain stockpiles of essential medicines and countermeasures against potential biological threats. Comparable spending benchmarks would typically involve other large-volume procurements of critical care pharmaceuticals or vaccines for national stockpiles.

Small Business Impact

There is no indication that this contract included a small business set-aside. Given the specialized nature of pharmaceutical manufacturing and the specific product (Leukine), it is likely that the primary awardee is a large business with the necessary capabilities and regulatory approvals. Subcontracting opportunities for small businesses may exist within the supply chain for raw materials or components, but these are not explicitly detailed in the award information. The impact on the small business ecosystem is likely minimal for this specific contract.

Oversight & Accountability

Oversight for this contract is likely managed by the Department of Health and Human Services, specifically the Office of the Assistant Secretary for Preparedness and Response (ASPR), which is responsible for the Strategic National Stockpile. Accountability measures are embedded in the contract terms, including delivery schedules and quality specifications. Transparency is facilitated through contract award databases like FPDS. Inspector General jurisdiction would apply in cases of fraud, waste, or abuse related to the contract.

Related Government Programs

Strategic National Stockpile
Biodefense Medical Countermeasures
Pharmaceutical Procurement
Emergency Preparedness and Response

Risk Flags

Potential for supply chain disruptions
Long contract duration introduces market volatility risk
Ensuring sustained contractor capacity over the contract period

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $59.0 million to PARTNER THERAPEUTICS, INC.. LEUKINE 250MCG/VIL INJ

Who is the contractor on this award?

The obligated recipient is PARTNER THERAPEUTICS, 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 $59.0 million.

What is the period of performance?

Start: 2022-07-25. End: 2024-03-29.

What is the historical spending pattern for Leukine by the Department of Health and Human Services?

Analyzing historical spending for Leukine by HHS reveals a consistent need for this critical medication, primarily driven by its role in the Strategic National Stockpile (SNS). While specific dollar amounts fluctuate year-to-year based on procurement cycles, contract renewals, and inventory management strategies, the aggregate spending reflects a long-term commitment to maintaining adequate supplies. For instance, prior awards for Leukine have also been significant, underscoring its importance in biodefense preparedness. The current $59 million award represents a substantial investment, but it should be viewed within the context of sustained funding for such essential medical countermeasures. Understanding these patterns helps in forecasting future budgetary needs and assessing the government's ongoing investment in public health security.

How does the price per unit of Leukine in this contract compare to previous awards or market benchmarks?

Determining the precise price per unit for Leukine in this $59 million contract is challenging without knowing the exact quantity of units procured. However, the contract's 'Firm Fixed Price' (FFP) structure suggests that the price per unit was negotiated and agreed upon upfront, providing cost certainty for the government. Given that this is a specialized pharmaceutical product critical for biodefense, direct price comparisons to commercial off-the-shelf items are not appropriate. Benchmarking would typically involve comparing this award to previous delivery orders under the same IDIQ vehicle or to other government contracts for similar biodefense medications. The fact that it was awarded under full and open competition implies that the government sought competitive bids, which should theoretically lead to a price that reflects market conditions and supplier capabilities, rather than an arbitrary figure.

What are the key performance indicators (KPIs) and deliverables associated with this contract?

Key performance indicators and deliverables for this contract primarily revolve around the timely and reliable delivery of Leukine injections meeting all specified quality and potency standards. The contract likely includes detailed specifications for the pharmaceutical product, such as dosage, formulation, packaging, and shelf-life requirements. Performance will be measured by the contractor's adherence to the delivery schedule outlined in the award, ensuring that the medication is available when needed for the Strategic National Stockpile. Quality assurance will be paramount, with potential requirements for contractor-provided certificates of analysis and compliance with Good Manufacturing Practices (GMP). Failure to meet these critical deliverables could result in contract penalties or termination, highlighting the importance of consistent performance in maintaining national health security.

What is the track record of Partner Therapeutics, Inc. in fulfilling government contracts, particularly for pharmaceuticals?

Partner Therapeutics, Inc. has a track record of engaging with government contracts, particularly in the pharmaceutical space. While this specific award is a significant sum, their experience likely includes navigating the complex regulatory and procurement landscape required for supplying medications to federal agencies. Assessing their broader track record would involve examining past performance on similar contracts, including delivery timeliness, product quality, and adherence to contractual terms. Government contract databases often contain past performance information, which agencies use in source selection. For a critical item like Leukine, the government would have vetted Partner Therapeutics' capabilities and reliability to ensure they could meet the demanding requirements of supplying the Strategic National Stockpile. Their ability to secure this contract under full and open competition suggests a positive assessment of their past performance and current capabilities.

What are the potential risks associated with the long contract duration (613 days)?

The 613-day duration for this Leukine contract, while indicating a sustained need, also introduces potential risks. One primary risk is market volatility; pharmaceutical prices or manufacturing costs could change significantly over this period, potentially impacting the long-term value proposition if not adequately managed through the fixed-price agreement. Another risk relates to the contractor's sustained operational capacity and financial stability; ensuring Partner Therapeutics can maintain production and delivery commitments throughout the contract term is crucial. Furthermore, technological advancements or the emergence of alternative treatments could occur, potentially rendering the procured medication less critical or obsolete by the contract's end. Finally, regulatory changes within the pharmaceutical industry could impact manufacturing processes or product specifications, requiring careful monitoring and potential contract modifications.

Industry Classification

NAICS: Manufacturing › Pharmaceutical and Medicine Manufacturing › Pharmaceutical Preparation Manufacturing

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

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: SUBJECT TO MULTIPLE AWARD FAIR OPPORTUNITY

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: ONE MARINA PARK DR, STE 900, BOSTON, MA, 02210

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $59,026,989

Exercised Options: $59,026,989

Current Obligation: $59,026,989

Actual Outlays: $59,026,989

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 36F79718D0593

IDV Type: FSS

Timeline