65--SOLVADI MCKESSON

Attachment 2: Request for Sole Source Memo Format DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition 1. Contracting Activity: Department of Veterans Affairs, VISN 11, VA Ann Arbor Healthcare System, 506-14-1-021-0374. 2. Nature and/or Description of the Action Being Processed: Emergency purchase of Sovaldi, a specialty pharmaceutical recently approved by the FDA, (12/9/2013) used to treat HEP C infections. A liver transplant patient at the VAAAHS needs this drug by 12/24/2013. 3. Description of Supplies/Services Required to Meet the Agency's Needs: Sofosbuvir (Sovaldi), 400mg, 1 bottle. $28,000. McKesson Corporation, One Postal Street, San Fransisco, CA 94104 4. Statutory Authority Permitting Other than Full and Open Competition: ( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; (X ) (2) Unusual and Compelling Urgency per FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3; ( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5; ( ) (6) National Security per FAR 6.302-6; ( ) (7) Public Interest per FAR 6.302-7; 5. Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Of all the vendors contacted, only McKesson Corporation could provide this drug on an overnight basis and assure delivery by 12/24/2013. 6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A list of distributors was obtained from the manufacturer, Gilead Scientific, no vendor contacted was able to provide the drug overnight. 7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: $28,000/bottle. This price is fair and reasonable based on prices obtained from local pharmacies. The CVS pharmacy, 3535 Plymouth road, Ann Arbor, MI 48105 l provided a price of $32,931.99/bottle. 8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: FSS and the internet were searched. The manufacturer, Gilead Scientific was contacted they provided a list of distributors. Every distributor contacted refused to give a current price or provide this drug, only McKesson, who is a current vendor for the VAAAHS agreed to provide this drug. 9. Any Other Facts Supporting the Use of Other than Full and Open Competition: This drug was approved by the FDA 12/9/2013 and is in short supply. 10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: McKesson Corp. 11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Should another requisition of this nature reoccur we would undertake a new market survey 12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. _____________________________ ________________________ Name Date Title Facility 13. Approvals in accordance with FAR 6.304 This part if filled out by Contracting Staff as part of the Justification a. Contracting Officer's Certification: (required) I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ ________________________ Name Date Title Network 11 Contract Office b. NCM/PCM (Required $3K and above): I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ Name Date NCM/Supervisory Contract Specialist (as appropriate) Network 11 Contract Office