Mandrake 3.0 JOFOC FINAL - SAM.gov.pdf

SBU - CONTRACTING AND ACQUISITIONS

JUSTIFICATION AND APPROVAL (J&A)

FOR OTHER THAN FULL AND OPEN COMPETITION

FAR Part 6.3 FAR 6.302-1(c) - Brand name

1. Identification of the agency and the contracting activity:

The Department of State Office of Acquisition Management is conducting this acquisition of other than full and open competition for brand name nerve agent antidote autoinjectors (DuoDote) on behalf of the Directorate of Operational Medicine (MED/DO/OM). The total estimated value of the acquisition is

2. Nature and/or description of the action being approved.

The proposed acquisition is to issue a new indefinite delivery, indefinite quantity (IDIQ) contract with a total value of on a firm-fixed price basis for the vendor’s proprietary, FDA-approved, nerve agent antidote autoinjectors (DuoDote) and autoinjector trainers to the following source:

Company: Meridian Medical Technologies, Inc Company Address: 8053 Litzsinger Rd, Saint Louis, Missouri, 63144-2505 Company Unique Entity ID: VBM4PLZ9VBC4 Company Point of Contact: Jonathan Daproza, (443) 878-7334

3. A description of the supplies or services required to meet the Department’s needs.

Chemical nerve agent exposure has immediate adverse effects on exposed individuals.

Treatment of exposure to organophosphate nerve agents having acetylcholinesterase activities requires the use of atropine and other medical countermeasures. Delays in administration of the medical countermeasures may result in long term adverse health effects or death. MED/DO/OM is responsible for implementing response programs for Chief of Mission staff employed overseas in U.S. Embassies for chemical nerve agent exposure. The product, hereinafter described as an autoinjector, consists of both a delivery device and a drug. Exposure to chemical nerve agents can be the result of accidental releases and/or intentional releases of organophosphate agents. Such events may occur where immediate medical intervention other than by the exposed individual is impractical and/or may result in exposure of multiple individuals thus complicating an effective and rapid medical response outside of a traditional healthcare setting. Typically, it is assumed that a medical intervention requiring drawing the antidote from a single- or multi-dose vial into a syringe and then administering that antidote may be too time intensive or beyond the capability of exposed individuals or responders.

To ensure that immediate lifesaving antidotes are available after exposure to nerve agents, State must have a ready supply of autoinjectors that may be employed by either exposed individuals or first responders as required. Exposure to nerve agents results in cholinergic toxicity and requires two different medications: (1) atropine [prevents cholinergic activation through competition with muscarinic receptors]; and (2) oxime therapy in the form of pralidoxime. The U.S. Government requires FDA-approved autoinjectors filled with both atropine and pralidoxime that can be self-administered to protect against and mitigate the effects of individual or group exposure to nerve agents. State further requires training autoinjectors that can be used to simulate a response to nerve agent exposure to ensure covered personnel understand how to use the autoinjectors in the case of actual exposure.

State anticipates needing up to 314,660 units to provide full coverage to its personnel, as well as replacement autoinjectors that can be leveraged as units expire. To ensure personnel are properly trained an additional 2,500 of training devices are required. Due to budgetary uncertainty and variable shelf life of the product, State needs a flexible contracting arrangement to purchase autoinjectors as budgetary resources become available and based on varying product expiration dates. Therefore, State seeks a five-year IDIQ contract on a firm-fixed price basis with a one-year base period and four option periods with a total ceiling of for the life of the contract.

4. An identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 U.S.C. 3304, as implemented by FAR 6.3 and substantiated by the following:

☒ FAR 6.302-1(c) – Only one responsible source and no other supplies or services will satisfy agency requirements (application for brand-name descriptions).

5. A demonstration that the proposed contractor’s unique qualifications or the nature of the action require use of the authority cited.

State requires an FDA-approved product to ensure compliance with the Food, Drug, and Cosmetics Act. 21 U.S.C. 331(e) restricts the sale of drugs that have not been approved by the FDA under 21 U.S.C. 335. In implementing these statutes, FDA regulations at 21 C.F.R. Part 229 establish the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (hereafter: the “Orange Book”) to identify drug products approved on the basis of safety and effectiveness by the FDA. It is well established that the front-line treatment for exposure to nerve agents in the United States is combination of atropine and pralidoxime chloride.1 Review of the Orange Book shows only two approved drugs that contain pralidoxime chloride, of which, only one is an autoinjector: the vendor’s proprietary Duodote.

State also requires an FDA-approved product to meet the Secretary’s security responsibilities. Under 22 U.S.C. 4802 the Secretary of State is responsible for providing for the security of U.S. Government operations overseas, including protection of most U.S.

Government personnel on official assignment overseas. Within this population, the Secretary is responsible for members of the uniformed services serving under Chief of Mission authority. Ensuring that personnel are protected from nerve agent exposure falls within the scope of the Secretary’s security responsibilities. 10 U.S.C. 1107 requires special permission from the Secretary of Defense to administer non-FDA approved drugs to service members. Were State to utilize a non-FDA approved autoinjector, it would be impossible in the aftermath of an emergency nerve agent exposure to obtain the necessary Secretary of Defense approval to utilize a non-FDA approved autoinjector for service members covered under Chief of Mission authority as treatment must be administered within minutes of nerve agent exposure.

Given that the proposed source is the only vendor capable of providing an FDA-approved autoinjector, they are uniquely qualified to meet State’s requirements.

6. A description of efforts to ensure that offers were solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

State reviewed the Orange Book and conducted market research which made it apparent that the only approved product capable of meeting State’s requirements is the vendor’s DuoDote product. Given that the proposed source is the only vendor capable of providing an FDA-approved autoinjector, they are uniquely qualified to meet State’s requirements.

In accordance with FAR 6.302-1(c)(1)(ii)(B), the DuoDote is essential to the Government’s requirements because that specific brand-name item is the only drug approved by the FDA for the purpose of treating nerve agent exposure, thereby precluding consideration of a product manufactured by another company.

This is a commercial product. A Sources Sought was published and available in accordance with FAR 5.203(b) for 21 calendar days or 15 business days and gave potential offerors notice of this action, stating:

The Office of Acquisitions Management (AQM), U.S. Department of State (State), is seeking sources capable of providing the DuoDote Nerve Agent Auto-Injector (DuoDote). State is contemplating awarding a one-year base

1 See, e.g., Medical Management Guidelines for Nerve Agents: Tabun (GA); Sarin (GB); Soman (GD); and VX https://wwwn.cdc.gov/TSP/MMG/MMGDetails.aspx?mmgid=523&toxid=93 (accessed 7/20/2023); Nerve Agent Information for Emergency Medical Services, https://www.phe.gov/Preparedness/planning/Documents/Nerve-Agent- Info-EMS-Hosp.pdf (accessed 7/20/2023).

https://wwwn.cdc.gov/TSP/MMG/MMGDetails.aspx?mmgid=523&toxid=93 https://www.phe.gov/Preparedness/planning/Documents/Nerve-Agent-Info-EMS-Hosp.pdf https://www.phe.gov/Preparedness/planning/Documents/Nerve-Agent-Info-EMS-Hosp.pdf and four one-year option, indefinite delivery, indefinite quantity contract for DuoDote. The quantities to be ordered are estimated at 100,000 units minimum and 500,000 units maximum over the entire duration of the contract. However, the quantity may increase or decrease as State’s requirements change.

State received three responses to the Sources Sought (19AQMM23N0059). They are summarized as follows:

Vendor

FDA

Approved Product

Available for Delivery in

FY24

Includes required medication combination Notes

RV Global Solutions No No No

This was a non-responsive submission and it appears the vendor does not provide this type of product, instead they provide “experience in facilities support services, design, development, process improvement, testing, and roll-out of enterprise discovery, asset management and its associated IT Service Management functions”

Aktiv Pharma Group

No No – Current projected target: 2026

Yes

This vendor is working to develop a next generation autoinjector that may meet State’s requirements in the future.

The vendor wanted State to sponsor their research and development for a 2026 delivery at a cost between

Meridian Medical

Technologies Yes Yes Yes

This vendor has the only FDA-approved product and is available for immediate delivery.

7. A determination by the ordering activity Contracting Officer that the anticipated cost to the Government is fair and reasonable.

The Contracting Office determines that the anticipated price(s) will be fair and reasonable based on pricing negotiated by the Defense Logistics Agency for the same product as well as historical prices paid for non-FDA approved nerve agent autoinjectors. By signing the justification, the Contracting Officer makes a determination that the cost/price to the Government are expected to be fair and reasonable.

8. A description of the market survey conducted (see Part 10) and the results or a statement of the reasons a market survey was not conducted.

MED/DO/OM conducted extensive market research for suppliers capable of meeting the directorate’s requirement. Based on market surveillance, State is not aware of any competing manufactures that have started an FDA-approval process, a process which takes many years. Nonetheless, prior to exercising any option period on the contract, MED/DO/OM and AQM will perform an informal market survey to ensure that there are no other options that could meet the Department’s requirements.

9. Any other facts supporting the use of this justification.

None

10. A listing of any sources that expressed a written interest in the acquisition.

Three vendors expressed a written interest in the acquisition:

- Meridian Medical Technologies: Responded to State’s Sources Sought and was the only vendor capable of delivering an FDA-approved product in the specified timeframe.

- RV Global Solutions: Responded to the Sources Sought but nonresponsive to State’s requirements, indicated that they were interested in providing advisory services to State, not providing autoinjectors.

- Aktiv Pharma Group: Responded to the Sources Sought and proposed a research arrangement where State would fund their research and development of a new autoinjector that would still need to go through the FDA-approval process. Based on this vendor’s assessment, FDA approval would occur sometime in 2026.

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

The award of this contract under sole source allows the Department to field this critically needed capability. The Program Office will continue to work with the FDA to identify any new products that can meet State’s requirements, as well as coordinate with the Defense Logistics Agency to partner with them as they develop new autoinjector products. Each year, prior to exercising any option period, State will conduct a Sources Sought to determine if new market capabilities exist.