VA awards $173K contract for XYREM oral solution to Amneal Pharmaceuticals, highlighting pharmaceutical preparation manufacturing

Contract Overview

Contract Amount: $173,089 ($173.1K)

Contractor: Amneal Pharmaceuticals of NEW York, LLC

Awarding Agency: Department of Veterans Affairs

Start Date: 2024-11-01

End Date: 2025-10-31

Contract Duration: 364 days

Daily Burn Rate: $476/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: XYREM (SODIUM OXYBATE) ORAL SOLUTION.

Place of Performance

Location: SAINT LOUIS, SAINT LOUIS County, MISSOURI, 63121

State: Missouri Government Spending

Plain-Language Summary

Department of Veterans Affairs obligated $173,088.68 to AMNEAL PHARMACEUTICALS OF NEW YORK, LLC for work described as: XYREM (SODIUM OXYBATE) ORAL SOLUTION. Key points: 1. Contract awarded through full and open competition, suggesting a competitive bidding process. 2. The contract is for a fixed price, providing cost certainty for the government. 3. The duration of the contract is one year, indicating a short-term need. 4. The product, XYREM (SODIUM OXYBATE) ORAL SOLUTION, is a pharmaceutical preparation. 5. The awardee, Amneal Pharmaceuticals, is involved in pharmaceutical preparation manufacturing. 6. The contract is a delivery order, suggesting it's part of a larger contract vehicle.

Value Assessment

Rating: good

The contract value of $173,088.68 for a one-year supply of XYREM oral solution appears reasonable given the specialized nature of pharmaceutical products. Benchmarking against similar contracts for this specific medication would provide a more precise value-for-money assessment. However, the firm fixed-price structure helps mitigate cost overruns.

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 a bid. The number of bidders is not specified, but this procurement method generally fosters a competitive environment, which can lead to better pricing and terms for the government.

Taxpayer Impact: Full and open competition is beneficial for taxpayers as it maximizes the potential for cost savings through a robust bidding process, ensuring that the government receives competitive pricing.

Public Impact

Veterans receiving care from the Department of Veterans Affairs will benefit from the availability of this medication. The service delivered is the provision of pharmaceutical preparations, specifically XYREM oral solution. The geographic impact is primarily within the United States, serving VA facilities. The contract supports the pharmaceutical manufacturing sector and its associated workforce.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for price fluctuations if this is a sole-source follow-on without competitive re-evaluation.
Dependence on a single awardee for a critical medication could pose supply chain risks.

Positive Signals

Awarded through full and open competition, indicating a competitive market.
Firm fixed-price contract provides cost predictability.
Clear product specification ensures the correct medication is supplied.

Sector Analysis

The pharmaceutical preparation manufacturing sector is highly regulated and characterized by significant research and development costs, patent protections, and complex supply chains. Contracts like this, for specific medications, are common within the healthcare sector, particularly for government agencies like the VA. The market size for specialized pharmaceuticals can be substantial, with pricing often influenced by therapeutic value, manufacturing complexity, and market exclusivity.

Small Business Impact

The provided data does not indicate any small business set-aside or subcontracting requirements for this contract. Therefore, the direct impact on the small business ecosystem is likely minimal, unless Amneal Pharmaceuticals utilizes small businesses in its supply chain for this product.

Oversight & Accountability

Oversight for this contract would typically be managed by the Department of Veterans Affairs contracting officers and program managers. Accountability measures are embedded in the firm fixed-price contract terms, requiring delivery of the specified product. Transparency is generally maintained through contract award databases, though specific performance metrics may not be publicly disclosed.

Related Government Programs

Pharmaceuticals and Biologicals
Medical Supplies
Veterans Health Administration Services

Risk Flags

Potential for supply chain disruption
Reliance on a single awardee for critical medication

Frequently Asked Questions

What is this federal contract paying for?

Department of Veterans Affairs awarded $173,088.68 to AMNEAL PHARMACEUTICALS OF NEW YORK, LLC. XYREM (SODIUM OXYBATE) ORAL SOLUTION.

Who is the contractor on this award?

The obligated recipient is AMNEAL PHARMACEUTICALS OF NEW YORK, LLC.

Which agency awarded this contract?

Awarding agency: Department of Veterans Affairs (Department of Veterans Affairs).

What is the total obligated amount?

The obligated amount is $173,088.68.

What is the period of performance?

Start: 2024-11-01. End: 2025-10-31.

What is the track record of Amneal Pharmaceuticals of New York, LLC with the Department of Veterans Affairs?

Amneal Pharmaceuticals of New York, LLC has a history of receiving contracts from the Department of Veterans Affairs. While this specific award is for XYREM oral solution, a comprehensive review would involve examining past awards for similar or different pharmaceutical products, their values, and performance history. Analyzing past performance, including any reported issues or successes, is crucial for assessing the reliability of the contractor in fulfilling current and future obligations. A deeper dive into their contract history with the VA would reveal the extent of their engagement and their established performance patterns within the agency.

How does the awarded price compare to market rates for XYREM (SODIUM OXYBATE) ORAL SOLUTION?

Determining the precise market rate for XYREM (SODIUM OXYBATE) ORAL SOLUTION requires access to commercial pricing data and potentially other government contract awards for the same or comparable formulations. XYREM is a prescription medication used to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy. Its pricing can be influenced by factors such as dosage, quantity, and specific formulation. Without direct comparative data from other VA contracts or commercial price lists, it is challenging to definitively benchmark this $173,088.68 award. However, the firm fixed-price nature of the contract suggests that the VA has negotiated a set price, aiming for value within the competitive landscape.

What are the primary risks associated with this contract award?

The primary risks associated with this contract award include potential supply chain disruptions if Amneal Pharmaceuticals faces manufacturing or distribution issues. Given that XYREM is a specific medication, reliance on a single awardee, even if competitively selected, carries inherent risk. Another risk could be the potential for price increases in future contract periods if market conditions change significantly or if competition diminishes. Ensuring consistent quality and timely delivery of the pharmaceutical product is also a critical risk area that requires ongoing monitoring by the VA.

How effective is the Department of Veterans Affairs in procuring pharmaceuticals through competitive bidding?

The Department of Veterans Affairs (VA) generally employs robust procurement processes, including competitive bidding, for pharmaceuticals. The use of 'full and open competition' for this contract indicates the VA's commitment to leveraging market forces to obtain favorable pricing and product availability. The VA's Federal Supply Schedule (FSS) program, for instance, facilitates competitive pricing for a wide range of medical supplies and pharmaceuticals. However, the effectiveness can vary depending on the specific drug, market dynamics, and the number of qualified bidders. For highly specialized or patented drugs, the competitive landscape might be more limited, potentially impacting the degree of price competition.

What is the historical spending pattern for XYREM (SODIUM OXYBATE) ORAL SOLUTION by the Department of Veterans Affairs?

Analyzing historical spending patterns for XYREM (SODIUM OXYBATE) ORAL SOLUTION by the Department of Veterans Affairs (VA) would involve reviewing past contract awards for this specific drug. This would reveal trends in contract values, awardees, and contract types over time. Understanding these patterns can help identify whether spending has been increasing or decreasing, whether the VA has consistently used competitive bidding, and if there have been significant shifts in pricing. Such historical data is essential for forecasting future needs and budgeting, as well as for assessing the long-term value and cost-effectiveness of procuring this medication.

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: 50 HORSEBLOCK RD, BROOKHAVEN, NY, 11719

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

Financial Breakdown

Contract Ceiling: $173,089

Exercised Options: $173,089

Current Obligation: $173,089

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Parent Contract

Parent Award PIID: 36F79722D0161

IDV Type: FSS

Timeline