HHS Awards $70.7M Contract for Influenza Treatment Development
Contract Overview
Contract Amount: $70,748,205 ($70.7M)
Contractor: Romark Laboratories, L.C.
Awarding Agency: Department of Health and Human Services
Start Date: 2013-02-28
End Date: 2015-12-31
Contract Duration: 1,036 days
Daily Burn Rate: $68.3K/day
Competition Type: FULL AND OPEN COMPETITION
Number of Offers Received: 6
Pricing Type: COST PLUS FIXED FEE
Sector: Healthcare
Official Description: IGF::OT::IGF ADVANCED DEVELOPMENT OF NITAZOXANIDE, ADMINISTERED ALONE OR IN COMBINATION WITH OSELTAMIVIR, FOR TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA VIRUS INFECTION IN ADULTS AND PEDIATRIC PATIENTS AT LEAST 12 YEARS OF AGE
Place of Performance
Location: TAMPA, HILLSBOROUGH County, FLORIDA, 33607
State: Florida Government Spending
Plain-Language Summary
Department of Health and Human Services obligated $70.7 million to ROMARK LABORATORIES, L.C. for work described as: IGF::OT::IGF ADVANCED DEVELOPMENT OF NITAZOXANIDE, ADMINISTERED ALONE OR IN COMBINATION WITH OSELTAMIVIR, FOR TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA VIRUS INFECTION IN ADULTS AND PEDIATRIC PATIENTS AT LEAST 12 YEARS OF AGE Key points: 1. Contract focuses on advanced development of Nitazoxanide for influenza treatment. 2. Competition was full and open, suggesting a competitive bidding process. 3. The contract value is substantial, indicating significant investment in this research area. 4. The sector is Pharmaceutical Preparation Manufacturing, a key area for public health. 5. Potential risk lies in the efficacy and market adoption of the developed treatment.
Value Assessment
Rating: good
The contract value of $70.7M for pharmaceutical development appears reasonable given the scope of advanced research and clinical trials required. Benchmarking against similar R&D contracts for novel drug development would provide a more precise assessment.
Cost Per Unit: N/A
Competition Analysis
Competition Level: full-and-open
The contract was awarded under full and open competition, indicating that multiple vendors had the opportunity to bid. This method generally promotes competitive pricing and allows the government to select the best value offering.
Taxpayer Impact: The investment aims to improve public health by developing new influenza treatments, potentially reducing healthcare costs and economic impact associated with widespread outbreaks.
Public Impact
Development of new treatments for influenza could improve public health outcomes. Investment in pharmaceutical R&D supports innovation in the healthcare sector. Successful development could lead to reduced burden on healthcare systems during flu seasons. The contract duration suggests a long-term commitment to research and development.
Waste & Efficiency Indicators
Waste Risk Score: 50 / 10
Warning Flags
- Potential for R&D delays or failure to meet efficacy targets.
- Market acceptance and adoption challenges for a new drug.
- Dependence on specific manufacturing capabilities.
Positive Signals
- Addresses a critical public health need for effective influenza treatments.
- Full and open competition promotes value for taxpayer money.
- Investment in advanced pharmaceutical development.
Sector Analysis
This contract falls within the Pharmaceutical Preparation Manufacturing sector, which is crucial for public health preparedness and response. Spending in this area is often driven by the need for new therapies and pandemic preparedness.
Small Business Impact
The data does not indicate whether small businesses were involved in this contract. Further analysis would be needed to determine the extent of small business participation.
Oversight & Accountability
Oversight would typically be managed by the Department of Health and Human Services (HHS) and its Office of Assistant Secretary for Preparedness and Response (ASPR). Regular reporting and milestone reviews are standard for such development contracts.
Related Government Programs
- Pharmaceutical Preparation Manufacturing
- Department of Health and Human Services Contracting
- Office of Assistant Secretary for Preparedness and Response Programs
Risk Flags
- Potential for R&D failure.
- Long development timelines.
- Market adoption uncertainty.
- Reliance on specific scientific breakthroughs.
- Regulatory approval hurdles.
Tags
pharmaceutical-preparation-manufacturing, department-of-health-and-human-services, fl, definitive-contract, 10m-plus
Frequently Asked Questions
What is this federal contract paying for?
Department of Health and Human Services awarded $70.7 million to ROMARK LABORATORIES, L.C.. IGF::OT::IGF ADVANCED DEVELOPMENT OF NITAZOXANIDE, ADMINISTERED ALONE OR IN COMBINATION WITH OSELTAMIVIR, FOR TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA VIRUS INFECTION IN ADULTS AND PEDIATRIC PATIENTS AT LEAST 12 YEARS OF AGE
Who is the contractor on this award?
The obligated recipient is ROMARK LABORATORIES, L.C..
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 $70.7 million.
What is the period of performance?
Start: 2013-02-28. End: 2015-12-31.
What is the projected timeline for the advanced development of Nitazoxanide and its potential market entry?
The contract was awarded in February 2013 with an end date of December 2015, suggesting the initial development phase was intended to conclude within this period. However, advanced pharmaceutical development often involves multiple phases, including clinical trials and regulatory approval, which can extend well beyond the contract's initial term. Specific details on subsequent phases and market entry projections are not provided in this data.
What are the key performance indicators and success metrics for this contract to ensure value for taxpayer money?
Key performance indicators would likely include successful completion of preclinical and clinical trial phases, demonstration of Nitazoxanide's efficacy and safety compared to existing treatments (like oseltamivir), and achievement of specific development milestones within the contracted timeline and budget. The government would monitor these to ensure the investment yields a viable influenza treatment.
How does the cost-plus-fixed-fee (CPFF) contract type influence the risk and incentive for the contractor?
A Cost-Plus-Fixed-Fee (CPFF) contract covers allowable costs plus a fixed fee, providing the contractor with a guaranteed profit margin. While it shifts cost risk to the government, it incentivizes the contractor to complete the work. However, it may offer less incentive for cost control compared to fixed-price contracts, requiring robust government oversight to manage expenditures effectively.
Industry Classification
NAICS: Manufacturing › Pharmaceutical and Medicine Manufacturing › Pharmaceutical Preparation Manufacturing
Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services
Competition & Pricing
Extent Competed: FULL AND OPEN COMPETITION
Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE
Offers Received: 6
Pricing Type: COST PLUS FIXED FEE (U)
Evaluated Preference: NONE
Contractor Details
Address: 3000 BAYPORT DRIVE STE 200, TAMPA, FL, 33607
Business Categories: Category Business, Limited Liability Corporation, Manufacturer of Goods, Small Business, Special Designations, U.S.-Owned Business
Financial Breakdown
Contract Ceiling: $70,748,205
Exercised Options: $70,748,205
Current Obligation: $70,748,205
Contract Characteristics
Multi-Year Contract: Yes
Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED
Cost or Pricing Data: YES
Timeline
Start Date: 2013-02-28
Current End Date: 2015-12-31
Potential End Date: 2015-12-31 00:00:00
Last Modified: 2024-12-31
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