Signed_J A_-_Redacted.pdf

Justification for Other than Full and Open Competition In Accordance with 10 USC 2304(c)(l)

Zanamivir for Inhalation (Relenza)

1. Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, is the contracting activity.

2. The action being approved is the ability to solicit for DLA requirements on an Other Than Full and Open Competition basis.

3. The proposed acquisition will result in a contract for Zanamivir for Inhalation. The sole source for this drug is GlaxoSmithKline (GSK).

National Stock Number (NSN): 6505-01-535-5483

Estimated Quantity: 400,000 Packages Estimated Unit Price:

Estimated Dollar Value:

Contract Type: Firm Fixed Price Requirements

The estimated quantity is based on the direction given to DLA Troop Support by the Office of the Assistant Secretary of Defense for Health Affairs (OASD (HA))

4. The applicable statutory authority permitting Other Than Full and Open Competition is 10 U.S.C. 2304(c)(l), FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

5. OASD (HA) is responsible for maintaining DoD's SNS of anti-viral drugs to ensure that critical operational forces are protected during the time between when a pandemic influenza emerges and an effective vaccine becomes available. Zanamivir (Relenza) is one of the three anti-viral drugs approved by the Food and Drug Administration (FDA) for use against circulating influenza viruses.

Oseltamivir Phosphate (brand name Tamiflu) and Peramivir (brand name Rapivab) are the other two FDA approved anti-viral drugs. The differences between Zanamivir (Relenza), Oseltamivir Phosphate (Tamiflu) and Peramivir (Rapivab) are how they are administered and their age of use.

Zanamivir (Relenza) is a powder that is inhaled, Oseltamivir Phosphate (Tamiflu) is available as a pill or liquid and Peramivir (Rapivab) is administered intravenously by a health care provider.

Zanamivir (Relenza) is FDA approved for the treatment of influenza in persons aged seven (7) years and older, and for the prevention of influenza in persons aged five (5) years and older. Oseltamivir Phosphate (Tamiflu) is FDA approved for the treatment of influenza in persons aged two (2) weeks and older, and for the prevention of influenza in persons aged one ( 1) year and older. Peramivir (Rapivab) is FDA approved for use only in adults aged eighteen (18) and older. Both Zanamivir (Relenza) and Oseltamivir Phosphate (Tamiflu) are included in DoD's Pandemic Influenza preparedness program. DoD does not purchase Peramivir (Rapivab ). There is a simultaneous procurement of Oseltamivir Phosphate (Tamiflu) as OASD (HA)

In Accordance with 10 USC 2304(c)(l)

Zanamivir for Inhalation (Relenza)

6. As required by FAR 5.2, the acquisition will be synopsized in FedBizOpps. In addition, this justification will be made available for public inspection, after award, in accordance with FAR 6.305(a). This procurement is being solicited under a specification with essential characteristics.

7. As the Contracting Officer; I hereby determine that the anticipated cost to the Government will be fair and reasonable based on price analyses, including comparison to commercial sales. This product is sold in substantial quantities to the general public.

8. Market research conducted on the Internet indicated that GSK is currently the only known manufacturing source for Zanamivir (Relenza) approved for sale by the FDA. The patent for this item expired in December 2014 and, according to the FDA, there are currently no other therapeutic equivalent (brand name or generic) products available in the marketplace.

A Sources Sought Notice was issued on September 23, 2015 via the FedBizOpps website seeking sources capable of providing Zanamivir (Relenza). It closed on October 26, 2015 with no responses received; however, GSK expressed interest in fulfilling these requirements while queried during market research.

9. There are no other facts supporting the use of this justification.

10. GSK is the only firm that has expressed interest in fulfilling the Government's requirements.

11. The Government has minimal ability to effect competition in the production of Zanamivir (Relenza) based on the fact that GSK is currently the only FDA approved source available. In an effort to foster competition, the Government is procuring this item via a specification with essential characteristics. In accordance with FAR 6.302-1 ( d)(2), any proposal in response to this notice will be considered. Prior to any future acquisitions, DLA Troop Support Pharmaceutical Distribution will perform market research to see ifthere are any additional FDA approved manufacturing sources available. ·

12. As the contracting officer, I hereby certify that this justification is accurate and complete to the best of my knowledge and belief.

u -3)-J VJ Date C . RISTINA L. IZZI

Contracting Officer

I hereby certify that the requirements which form the basis of this justification are accurate, that these supplies and services meet the Government's needs in accordance with applicable specifications and that this justification is accurate and o t e t of my knowledge and belief.

:Sf ~ ?Ctk, Date'

L

In Accordance with 10 USC 2304(c)(l)

Zanamivir for Inhalation (Relenza)

I have reviewed and recommend approval of this Justification.

Date THERESA RUCCI

Chief, Phann. Manufacturing /DVD Division

I have reviewed and recommend approval of this Justification.

Date Director, Supplier erations Medical Supply C ain

I have reviewed this Justification for legal sufficiency.

Date

I have reviewed and hereby approve this Justification.

If '{1, Date ROBERT J/ PANICHELLE

DLA Troop Support Competition Advocate