JA_Prasugrel Short Term Contract.pdf

Justification and Approval For Other Than Full and Open Competition due to Unusual and Compelling Urgency

National Acquisition Center

FAR 6.302-2

1. Contracting Activity:

Department of Veterans Affairs (VA) Office of Procurement, Acquisition and Logistics National Acquisition Center (NAC) Building 37, One Block North of 22nd Street Hines, IL 60141

2. Nature and Description of Action:

The proposed action is to award one non-competitive (sole source) Firm Fixed Price, Indefinite Delivery, Requirements-type contract for Prasugrel Hydrochloride (HCL) 5 milligram

(mg) and 10mg tablets for a three-month period with an option to extend an additional two months.

Prasugrel HCL Tablets were previously available to VA and other participating agencies via contract 36E79720D0007, which was awarded and administered by VA NAC. Contract 36E79720D0007 was awarded to Golden State Medical Supply, Inc. (GSMS) on January 16, 2020, and expired on February 20, 2025.

A solicitation, Request for Proposals (RFP) 36E79724R0024, was issued for full and open competition for Prasugrel HCL Tablets on September 13, 2024, with a due date and time for offers (extended via Amendment 0001) of October 8, 2024, at 2:30 PM Central Time. Like the expiring contract, RFP 36E79724R0024 sought award of a single Firm Fixed Price, Indefinite Delivery, Requirements-type contract with one base year ordering period and four one-year options.

Contract 36E79725D0013 was awarded to GSMS on January 27, 2025. However, this award has been protested by Cosette Pharmaceuticals, Inc., to the Court of Federal Claims, Case Number 25-279C, and a stay of performance of the new contract is in place.

A short-term contract, contract number 36E79725D0024, was awarded to GSMS on February 25, 2025, with the goal of ensuring supply until the protest regarding 36E79725D0013 was adjudicated or settled. Due to the urgent and compelling need, this requirement was not competed; a justification and approval for other than full and open competition in accordance with FAR 6.302-2 was signed by the Contracting Officer on February 26, 2025. Contract 36E79725D0024 contains an ordering period of March 3, 2025, through June 2, 2025.

However, the contracting office has learned that the protest case regarding 36E79725D0013 will not be heard until after the expiration of short-term contract 36E79725D0024.

Award of a short-term contract to GSMS will ensure that VA and other participating federal

Justification & Approval – Prasugrel HCL Tablets Short Term Contract government agencies have access to a consistent source of supply of Prasugrel HCL Tablets until the protest regarding 36E79725D0013 is adjudicated or settled. As GSMS is the holder of the expiring national contract 36E79720D0007 and short-term contract 36E79725D0024, a second short-term contract with GSMS ensures that the product itself will remain unchanged, thus eliminating the need for patients to receive new prescriptions and be switched to another version of Prasugrel HCL Tablets or another drug that treats the same indications.

3. Description of Supplies or Services:

The Veterans Health Administration (VHA) Pharmacy Benefits Management (PBM) has identified Prasugrel HCL Tablets as uniform preferred products for standardization. VA national standardization contracts are awarded to acquire critical drug products in the package sizes and specifications required by VA and other participating agencies. National Standardization contracts require that contractors maintain an uninterrupted supply of products available with the Pharmaceutical Prime Vendors (PPVs) throughout the contract period. An uninterrupted supply is critical to ensure that patients receive the pharmaceuticals they require with consistent specifications and without delays.

The purpose of this acquisition is to ensure a continued national contract source for Prasugrel HCL Tablets for VA, Department of Defense (DoD), Bureau of Prisons (BOP), Indian Health Service (IHS), State Veteran Homes (Option 2 only), and the Federal Health Care Center until the protest regarding contract 36E79725D0013 is resolved. Prasugrel HCL Tablets are used to treat heart/blood vessel problems. The contracted items will be ordered and delivered via the VA and DoD Pharmaceutical Prime Vendor programs. The required products and estimated requirements for a three-month ordering period are below:

Item

Description and

Strength

Package Size

(Tablets per

Bottle)

Estimated usage, Three Months

(Bottles)

Estimated usage, Three Months +

Two Months

Option Period

(Bottles)

1 Prasugrel HCL 10mg

Tablets

20,066 33,443

2 Prasugrel HCL 5mg Tablets

1,182 1,969

The total estimated value for the three-month base period of this contract is $122,271.12. The total estimated value, inclusive of the two-month option period (and therefore a total contract period of five months), is $203,777.12. The estimates were calculated using the estimated requirements and awarded unit pricing.

The contractor is required to have a unique, 11-digit National Drug Code (NDC) number for all offered items. The NDC number must be specific to the contractor and to the drug being supplied. All bottles must be compatible with automated dispensing units (Baxter ATC

Canisters, Optifill, etc.). All NDCs must be registered with the Food and Drug Administration (FDA), First Data Bank, Medispan, and Multum. The contractor’s utilized manufacturing facilities and other places of performance must be FDA current Good Manufacturing Practices (cGMP) acceptable for the contracted product type.

A Nonavailability Determination was issued on June 18, 2019, and approved by the Head of Contracting, as Prasugrel HCL Tablets is a product of India.

4. Statutory Authority Permitting Other Than Full and Open Competition:

The statutory authority permitting other than full and open competition is 41 U.S.C. § 3304(a)(2) as implemented by the Federal Acquisition Regulation (FAR) Section 6.302-2 entitled, “Unusual and Compelling Urgency.”

In accordance with FAR 6.304(a)(1), the Contracting Officer’s certification in Section 12 of this justification and approval (J&A) document will serve as approval of this document, as the proposed contract’s value is less than $750,000 and no VA procedures require a higher approving level.

When combined and including options, the two short-term contracts for Prasugrel HCL Tablets cover an ordering period of eight months and have a total estimated value of $326,048.24. This eight-month period is less than the one-year maximum period permitted by FAR 6.202-2(d)(ii).

5. Rationale Justifying Use of Cited Statutory Authority:

An urgent and compelling need has emerged for Prasugrel HCL Tablets. The previous national contract, 36E79720D0007, was awarded to Golden State Medical Supply, Inc.

(GSMS) on January 16, 2020, and expired on February 20, 2025. A follow-on contract, 36E79725D0013, was awarded to GSMS on January 27, 2025. However, this award has been protested and a stay of performance of the new contract is in place. This short-term contract is necessary to ensure availability of Prasugrel HCL Tablets for VA and other agencies until the protest is resolved and performance.

A short-term contract, contract number 36E79725D0024, was awarded to GSMS on February 25, 2025, with the goal of ensuring supply until the protest regarding 36E79725D0013 was adjudicated or settled. Due to the urgent and compelling need, this requirement was not competed; a justification and approval for other than full and open competition in accordance with FAR 6.302-2 was signed by the Contracting Officer on February 26, 2025. Contract 36E79725D0024 contains an ordering period of March 3, 2025, through June 2, 2025.

However, the contracting office has learned that the protest case regarding 36E79725D0013 will not be heard until after the expiration of short-term contract 36E79725D0024.

Without this short-term contract, VA and other participating agencies may not have access to an uninterrupted supply of this critical pharmaceutical. Prasugrel HCL Tablets are available on one FSS contract, but at extremely high prices (more than 40 times higher) compared to the short-term contract pricing with GSMS, the holder of expired contract 36E79720D0007.

Furthermore, presence of a product on an FSS contract (or non-contract basis through the Pharmaceutical Prime Vendor) does not guarantee that the product will be in stock at any one time, let alone that an FSS contract holder can guarantee an uninterrupted supply over a sustained period.

Establishment of a short-term contract with the recently expired national contract holder under the authority at FAR 6.302-2 is in the Government’s best interest, as this contract will ensure continued availability of Prasugrel HCL Tablets and will ensure VA and other participating agencies can acquire Prasugrel HCL Tablets at fair and reasonable prices.

6. Description of Efforts to Solicit Offers from as Many Sources as Practicable:

Notice of this J&A will be publicized in accordance with FAR 6.305(b). As this acquisition is of unusual and compelling urgency, the contracting office did not have the time necessary to solicit multiple sources or publish a solicitation to SAM.gov. Contract 36E79725D0013, which was awarded on January 27, 2025, and which has a stay in performance in place until resolution of a bid protest, was competitively solicited and provided for full and open competition.

7. Fair and Reasonable Price Determination:

The unusual and compelling need requiring immediate award of this short-term contract did not allow for a competitive solicitation. Nonetheless, the Contracting Officer was able to compare proposed pricing with historically paid pricing for Prasugrel HCL Tablets, such as on the recently expired national contract 36E79720D0007. Furthermore, GSMS’s proposed pricing for Prasugrel HCL Tablets was found to be more favorable than the pricing available for comparable products from other sources, including on Federal Supply Schedule contracts and products available on a non-contract basis to participating agencies via the Pharmaceutical Prime Vendors.

In accordance with FAR 15.404-1(b)(2), the Contracting Officer has determined that prices offered by GSMS are fair and reasonable based on a comparison with historically paid pricing (FAR 15.404-1(b)(2)(ii)) and a comparison with published price list/market prices (FAR 15.404-1(b)(2)(iv)).

8. Market Research:

Due to the unusual and compelling need for this short-term contract, the Contracting Officer was unable to competitively solicit this requirement. Nonetheless, as the recently awarded 36E79725D0013 was competitively solicited, the Contracting Officer has recent data on availability of the drug in the U.S. market. Furthermore, the Contracting Officer reviewed Prasugrel HCL Tablets pricing data available to VA and other agency customers to ensure that proposed pricing for this short-term contract is fair and reasonable.

9. Other Facts:

This contract will consist of a single three-month ordering period with one two-month option period. The purpose of this short-term contract award is to ensure availability of Prasugrel HCL Tablets for VA and other agencies until the protest of 36E79725D0013 is resolved.

Without this short-term contract, VA and other participating agencies may not have access to an uninterrupted supply of Prasugrel HCL Tablets until the protest concerning 36E79725D0013 is resolved. The health of Veterans and other agency patients would be jeopardized without access to this critical pharmaceutical. Furthermore, the Firm Fixed prices secured by the Government in this short-term contract are far more favorable to the Government than any pricing available on other sources, including FSS contracts. Therefore, award of this short-term contract allows VA to serve its mission in the most cost-efficient manner possible.

10. Sources Expressing Interest:

As noted above, due to the unusual and compelling need for Prasugrel Tablets, the contracting office could not competitively solicit for this requirement. GSMS, the holder of recently expired contract 36E79720D0007 and expiring short-term contract 36E79725D0024, was interested and has immediate product availability of the same product as that on the previous national contract.

11. Actions to Remove Barriers to Future Competition:

As the purpose of this short-term contract award is to ensure availability of Prasugrel HCL Tablets for VA and other agencies until the protest of 36E79725D0013 is resolved, no barriers to future competition have been identified. Any future acquisition for Prasugrel HCL Tablets after the resolution of the current protest will maximize competition to the greatest extent practicable.

12. Certifications:

Technical and Requirements Certification:

I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

Sue Patterson Date Pharmacist Pharmacy Benefits Management

Procuring Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Nicholas I. McGregor Date Contracting Officer National Acquisition Center