HHS awarded $37.7M for Colony Stimulating Factors, a biological product, to Amgen USA Inc

Contract Overview

Contract Amount: $37,675,457 ($37.7M)

Contractor: Amgen USA Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2016-09-30

End Date: 2021-09-29

Contract Duration: 1,825 days

Daily Burn Rate: $20.6K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 2

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: IGF::OT::IGF FOR OTHER FUNCTIONS PROJECT: ACQUISITION OF COLONY STIMULATING FACTOR(S) (G-CSF OR GM-CSF) FOR MITIGATION OF NEUTROPENIA ARISING FROM EXPOSURE TO IONIZING RADIATION (RTOR-CSF-0003)

Place of Performance

Location: NEWBURY PARK, VENTURA County, CALIFORNIA, 91320

State: California Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $37.7 million to AMGEN USA INC for work described as: IGF::OT::IGF FOR OTHER FUNCTIONS PROJECT: ACQUISITION OF COLONY STIMULATING FACTOR(S) (G-CSF OR GM-CSF) FOR MITIGATION OF NEUTROPENIA ARISING FROM EXPOSURE TO IONIZING RADIATION (RTOR-CSF-0003) Key points: 1. Contract awarded for critical medical countermeasures against radiation exposure. 2. Focus on mitigating neutropenia, a serious side effect of radiation. 3. Biological product manufacturing sector, indicating specialized industry involvement. 4. Long-term contract duration of 5 years suggests sustained need. 5. Firm Fixed Price contract type aims to control costs. 6. Delivery Order under an existing contract indicates a structured procurement process.

Value Assessment

Rating: good

The contract value of $37.7 million over five years for Colony Stimulating Factors (CSF) appears reasonable given the specialized nature of the product and its critical application in public health emergencies. Benchmarking against similar contracts for biological countermeasures is challenging due to the niche market, but the price per unit, if available, would offer further insight. The firm fixed-price structure provides cost certainty for the government.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, suggesting that multiple vendors had the opportunity to bid. The presence of two bidders indicates a degree of competition, which is generally favorable for price discovery and ensuring the government receives competitive pricing. The specific details of the bidding process and the number of proposals received would provide a more complete picture of the competitive landscape.

Taxpayer Impact: Full and open competition generally benefits taxpayers by driving down prices through market forces and encouraging innovation among potential suppliers.

Public Impact

Beneficiaries include individuals potentially exposed to ionizing radiation, such as first responders or military personnel. Services delivered include the provision of essential biological products (G-CSF or GM-CSF) for medical treatment. Geographic impact is national, as the Strategic National Stockpile serves the entire United States. Workforce implications are minimal in terms of direct job creation from this contract, but it supports jobs in the biopharmaceutical manufacturing sector.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for supply chain disruptions in specialized biological manufacturing.
Dependence on a single supplier for a critical medical countermeasure could pose a risk if not managed with robust inventory and contingency plans.

Positive Signals

Contract addresses a critical national security and public health need.
Long-term commitment allows for stable supply and planning.
Firm fixed price provides budget predictability.

Sector Analysis

This contract falls within the biopharmaceutical manufacturing sector, specifically focusing on biological products used as medical countermeasures. This is a highly specialized area driven by significant R&D investment and stringent regulatory requirements. The market for such products is often characterized by a limited number of qualified manufacturers and long development cycles. Government procurement in this space is crucial for ensuring national preparedness against biological and radiological threats.

Small Business Impact

The contract data indicates that small business participation was not a primary focus, as the awardee is a large corporation and the contract was not set aside for small businesses. There is no explicit information on subcontracting plans for small businesses. This suggests that the primary goal was securing a specialized product from a capable manufacturer, rather than promoting small business engagement.

Oversight & Accountability

Oversight for this contract would typically fall under the Department of Health and Human Services (HHS), specifically the Office of the Assistant Secretary for Preparedness and Response (ASPR). Mechanisms likely include regular performance reviews, quality assurance checks, and adherence to the terms of the delivery order. Transparency is generally maintained through contract databases, though specific operational details may be sensitive.

Related Government Programs

Strategic National Stockpile
Biomedical Advanced Research and Development Authority (BARDA) contracts
Medical Countermeasures Initiative

Risk Flags

Sole-source risk (if competition was limited in practice)
Supply chain vulnerability for specialized biologics
Long-term contract dependency

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $37.7 million to AMGEN USA INC. IGF::OT::IGF FOR OTHER FUNCTIONS PROJECT: ACQUISITION OF COLONY STIMULATING FACTOR(S) (G-CSF OR GM-CSF) FOR MITIGATION OF NEUTROPENIA ARISING FROM EXPOSURE TO IONIZING RADIATION (RTOR-CSF-0003)

Who is the contractor on this award?

The obligated recipient is AMGEN USA 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 $37.7 million.

What is the period of performance?

Start: 2016-09-30. End: 2021-09-29.

What is the historical spending pattern for Colony Stimulating Factors by HHS?

Historical spending data for Colony Stimulating Factors (CSF) by the Department of Health and Human Services (HHS) prior to this specific award would provide valuable context. Analyzing previous awards for similar products, their values, durations, and awardees can reveal trends in government procurement strategies for medical countermeasures. For instance, has HHS consistently relied on Amgen USA Inc. for these products, or have there been shifts in suppliers? Understanding the historical investment in CSFs can also indicate the perceived threat level and the government's long-term commitment to preparedness in this area. Without specific historical data points, it's difficult to ascertain if this $37.7 million award represents an increase, decrease, or stable level of spending compared to past procurements.

How does the price of these Colony Stimulating Factors compare to market rates for similar biological products?

Benchmarking the price of these Colony Stimulating Factors (CSFs) against market rates for similar biological products is crucial for assessing value for money. This comparison should consider not only the unit price but also the specific formulation, dosage, and intended use. Products like G-CSF and GM-CSF are complex biologics, and their pricing can vary significantly based on manufacturing processes, research and development costs, and market exclusivity. If comparable products are available on the commercial market or through other government contracts, a direct price-per-unit or price-per-treatment-course comparison can be made. Factors such as the scale of production for government stockpiling versus commercial sales, and the inclusion of specific service requirements, might justify price differences. A detailed analysis would require access to specific product pricing and potentially proprietary cost structures.

What are the specific risks associated with relying on Amgen USA Inc. for this critical countermeasure?

Relying on a single contractor, even a reputable one like Amgen USA Inc., for a critical countermeasure like Colony Stimulating Factors (CSFs) introduces several risks. These include potential supply chain disruptions due to manufacturing issues, natural disasters, or geopolitical events affecting Amgen's operations. There's also the risk of price increases in future contract renewals if competition is limited. Furthermore, over-reliance on one supplier could stifle innovation from other potential manufacturers. To mitigate these risks, the government might employ strategies such as maintaining strategic reserves, fostering relationships with alternative suppliers for future needs, and conducting regular performance and risk assessments of the primary contractor. The government's contingency planning and contract management practices are key to addressing these vulnerabilities.

What is the effectiveness of Colony Stimulating Factors in mitigating neutropenia from radiation exposure?

Colony Stimulating Factors (CSFs), such as G-CSF (filgrastim) and GM-CSF (sargramostim), are well-established therapeutics proven effective in mitigating neutropenia, a critical side effect of radiation exposure. Neutropenia, characterized by a dangerously low count of neutrophils (a type of white blood cell), severely compromises the immune system, making individuals highly susceptible to life-threatening infections. CSFs work by stimulating the bone marrow to produce more neutrophils, thereby accelerating the recovery of white blood cell counts. Clinical studies and real-world applications, particularly in cancer chemotherapy and stem cell transplantation, have demonstrated their efficacy. For radiation exposure scenarios, CSFs are considered a vital medical countermeasure to support the survival and recovery of affected individuals by bolstering their immune defenses.

How does this contract align with broader U.S. government strategies for biodefense and public health preparedness?

This contract for Colony Stimulating Factors (CSFs) aligns directly with broader U.S. government strategies for biodefense and public health preparedness, particularly those focused on radiological and nuclear threats. Agencies like the Department of Health and Human Services (HHS), through entities such as the Office of the Assistant Secretary for Preparedness and Response (ASPR) and the Biomedical Advanced Research and Development Authority (BARDA), are tasked with developing and stockpiling medical countermeasures. CSFs are identified as critical MCMs for treating acute radiation syndrome (ARS) and mitigating its hematological effects. Procuring these agents ensures that the Strategic National Stockpile (SNS) is adequately provisioned to respond to a radiological event, thereby enhancing national resilience and the capacity to protect the public and first responders.

Industry Classification

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

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

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: SUBJECT TO MULTIPLE AWARD FAIR OPPORTUNITY

Solicitation ID: 12100SOL00016

Offers Received: 2

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Parent Company: Amgen Inc. (UEI: 039976196)

Address: 1 AMGEN CTR DR, THOUSAND OAKS, CA, 91320

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

Financial Breakdown

Contract Ceiling: $37,675,457

Exercised Options: $37,675,457

Current Obligation: $37,675,457

Actual Outlays: $1,324

Contract Characteristics

Multi-Year Contract: Yes

Commercial Item: SUPPLIES OR SERVICES PURSUANT TO FAR 12.102(F)

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: HHSO100201300006I

IDV Type: IDC

Timeline