Justification for Other than Full and Open Competition Parsuant to the requirements of the Competition in Contracting Act (CICA) as implemented by FAR Subpart 6.3 and in accordance with the requirements of PAR 6.303-1, the justification for the use of the statutory authority under FAR Subpart 6.3 is justified by the following facts and rationale required under FAR 6,303-2 as follows: (1) Agency and Contracting Activity. The Department of Homeland Security (DHS), Office of Health Affairs (OHA), proposes to enter into a contract on a basis other than full and ‘open competition, (2) Nature and/or description of the action being approved, The Department of Homeland Security (DHS), Office of Health Affairs (OHA), has a requirement on a sole source basis {o acquire the antiviral medicine zanamivir (trade name Relenza) from proposed contractor GlaxoSmithKline (GSK) at an estimated cost of SAMIR. GSK has a business office located at 9917 Carrington Place, Richmond, Virginia 23238. @) Description of Supplies. The contractor shall provide the antiviral medicine Relenca for the DHS Antiviral Stockpile for pandemic and avian influenza preparedness, [The stockpile is needed in order to have a readily available supply of medicines to protect DHS personnel in the event of a pandemic to ensure the continuity of its essential serviees and overall eritical mission. The medicine must be approved hy the Food and Drug Administration and demonstrated by the Centers for Disease Control to be effective in Geating Influenza A, HINI Influenza and HSN1 Avian Influenza. The medicine must also be able to be administered in the form of an inhalant or some other form that does not involve the oral ingestion of a pill or capsule. Packaging and labeling specifications of this antiviral medicine are as follows: Packaging/Labeling Specifications The medicine shall be packaged in 4 evenly spaced double-foiled blisters with each blister containing a powder mixture of 5 mg of zanamivir and 20 img of lactose. * Each package shall contain medicine sufficient for one course (5 days treatment or 10 days prophylaxis). * Product packaging shall be in accordance with Health and Human Services (HHS) Strategie National Stockpile (SNS) packaging, * Product labeling shall be in accordance with HHS SNS labeling. Maximum Unit Ordering Period uantit Price Amount Base Year with Four Opion Vaasa "OSs — (4) identification of Statutory Authority Permittin, Other Than Full and Open Competition. ‘The statutory authority permitting other than full and open competition is 4! U.S.C. 253(cX 1) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.302-1 entitled “Only One Responsible Source and No ‘Other Supplies or Services Will Satisfy Agency Requirements, Page | of 4(3) onstration Thar the Nature of the Acquisition Reguire Use of the Authority Cited. DHS requires an antiviral medicine that will treat and prevent (via post-exposue prophylaxis or outbreak prophylaxis) Influenza A, HINI Infhuenza and HSN1 Avian {nlluenca, This requirement isto protect the DHS workforce a) with potential risk of qpbosure to Pandemic Influenza and/or Avien Influenza virus(es) or 5) with job functions that are determined to be mission-critical and/or essential. A subset of the DAS Rorcforee population isnot able to take antiviral medicine via pill or gel-cap, horefore the form of an inhalant is required, Relenza isthe only antiviral shown to be effective and that comes in the form of an inhalant, The Center for Disease Control and Prevention (CDC) found Relenza to be effective in fre protective treatment and prevention of both Influenza Virus A (avian influenga ot tied flu) and Inuenza Virus B (common human flu). CDC concluded: “Relenea {has} shown @tfectiveness against the HSN1 (bird fluj virus.” Furthermore, the “appropriate use nf [this agent] during a flu pandemic may reduce morbidity and mortality aul dimineh she prerhelming demands that wil be placed on the healthcare system.” With regard to Protective treatment and/or prevention of infection with the HIN1 influenza virus, CDC also recommends the use of zanamivir (http://www. cde.gow/h In) flwantivira tm). Relenca does not have a generic equivalent available, This antiviral medicine is relatively new on the market and is covered by U.S. Patent No. 5,360,817, a U.§ Patent extension, and foreign patents. It is unique in its pharmaceutical formulation in The active component of Relenza is zanamivie. Zanamivir is a white to off-white powder for oral inhalation with solubility of approximately 18 mg/ml. in water at 20°C. The ajorty of anti-viral medicines are administered through an oral suspension. Relenza, powever, is unique. Relenza is for administration to the respiratory tract by oral inhalation only. Bach Refonza Rotodisk® contains 4 evenly spaced double soiled blisters with each blister containing a powder mixture of $ mg of zanamivir and 20 mg of lactose. The contents of each blister are inhaled using a specially designed breath-acti ated plastic te fake medicines orally. Consequently, Relenza antiviral medicine ensures that those individuals woutd be protected (6) Description of efforts made to ensure that offers are solicited from as mam ential polices cS is practicable, A notice of the proposed sole source award for the anti-viral medicines will be posted to FedBizOps. (7) Determination by the Contracting Officer thatthe Anticipated Cost to.the Government will be Fair and Reasonable, Te Contracting Officer will determine that the rice is fair and reasonable based on comparisons with the pricing previously negotiated fir ths medicine by HHS/CDC and the Department of Veterans Affairs (VA). Page 2 of 4(8) Peseription of Market Research, Macket research was performed in oxde to support the planned purchase of Relenza for the DIIS Antiviral Stockpile. Market research trond tbat in addition to Relenza, there are three other types of antiviral medicines oseltamivir, recommendation that oseltamivir {trade name Tamiflu) or zanamivir (trade name Relenza) be selected if an antiviral medication was used for the treatment snd Prophylaxis of influenza.' Tamiflu and Relenza were the two FDA-approved influenza. antiviral drugs recommended by CDC in the 2005-2006 flu season and are currently recommended for use against the 2009 HINI influenza virus? On September 8, 2009, CDC updated its recommendations for the use of influenza antiviral medicines to provide additional guidance for clinicians in preseribing antiviral medicines for treatment nd Prevention of influenza during the upcoming 2009-2010 flu season. As-to-date, the suldance remains the same ~ treatment with Tamiflu o: Relenza is recommended forall (9) Anwy Other Facts Susporting the Use of Other Than Full and Open Competition. i Unfortunately, the circulating influenza virus in the U.S., in recent years, has become : (aistant © the antiviral medicines ~ amantadine and rimantadine. Both Influenza Virus A j (Gvian influenza or bird fu) and Influenza Virus B (common human flu) have exhibited the ability to mutate; thus, becoming increasingly more resilient to amantadive svt ‘mnantadine. There are persistent doubts about the effectiveness of amantadine and Fimaatadine, CDC recommends that neither amantadine nor rimantadine be used for the treatment or prevention of influenza in the United States. | In adsition, CDC regards Tamiftu asa proven effective alternative to zanamivir in the i Greaiment and prevention of influenza, However, there is a proportion of the human Population that can not take Tamiflu due to its delivery system (orally via capsule or gel- cap). Therefore, some people will require anti-viral medicines to be adminiceered through oral inhalation, Relenza isthe only antiviral medicine show to be effective and | that comes in the form of an inhalant. | (10).d Listing of the Sources, if Any That Expressed. in Writing, an Interest in the icquisition. {het are no other sources that expressed in vriting an interest in the acquisition; however, all responses to the synopsis will be evaluated ‘ http://www.cde.cov/flu/han0 1 1406,btm 7 Btpv/swww. fda. gov/Drugs/DrugSafety/InformationbyDrugClass/uem 100228 ht * huipy/www Fda, gov/NewsEventyNewsroonPressAnnoune ements/2005/uem 10854 him Page3 of 4(11) 4 Statement of the Aetions, iL Any. the Agency May Take to Remove or Overcome Am Barriers to Competition Before Any Subsequent Acquisition for Supplies or Services Required, DHS continues to work with World Health Organization (WHO), HHS, CDC and otter Federal agencies to develop a pandemic vaccine. A vaccine would prevent the need for anti-viral medicines. However, the development of a vaccine is predicated upon isolating, repliceting, and clinically testing various influenza viruses In addition, DHS will continue to work with other federal agencies in developing alternate medicines that may be effective in treating or preventing influenza, and coordinate the purchase of these medicines using competitive procedures, if appropriate, (12) Contracting Officer's Certification. {certify thatthe data supporting the recommended use of other than full and open ‘competition is accurate and complete to the best of my knowledge and belief art /o9 Date _ Contracting Officer (13) Technical/Requirements Personnel Certification, T certify this requirement meets the Government’s minimum need and that the supporting data, which forms a basis for this justification, is complete and acourate _Afesfay Technical Rejfesentativ Date bfab2 JO “Date Page 4 of