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Company Receiving Preferential Treatment From Government Is Repudiated

PharmAthene tries to hide being admonished by FDA.

1:39 PM, Aug 26, 2010 • By DANIEL HALPER
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Company Receiving Preferential Treatment From Government Is Repudiated

THE WEEKLY STANDARD previously covered PharmAthene, reporting:

Several months ago we warned that Tara O'Toole who recently became Under Secretary for the Science and Technology Directorate at the Department of Homeland Security would reward her friends resulting in millions of dollars in gifts to John Murtha cronies who supported her nomination.  And it now appears the Murtha/O’Toole favor factory has begun production. In February 2008, the Department of Health and Human Services (HHS) issued a request for proposal (RFP) for a second-generation Anthrax vaccine.  This RFP was issued to be a re-procurement for a contract that had been canceled in 2006 for the same vaccine.  And on December 7, HHS canceled the RFP.  After further review, it is becoming all too clear why this happened.  Just as the year was closing and no one was paying attention, O’Toole’s friends at PharmAthene were awarded a sole-source contract, which has resulted in their stock nearly doubling. In the very same week America faced al Qaeda’s latest terrorist attack, it seems that the O’Toole-led homeland security ‘system worked’ for PharmAthene -- assuming the system is one of cronyism, political paybacks, and sole-source contracts. 

Since then, PharmAthene has continued to get taxpayer dollars, but hasn’t fared as well.  In July, the company issued a release saying:

it received a letter from the NYSE Amex LLC, stating that PharmAthene is not in compliance with the continued listing standards specified in Sections 1003(a)(i), (ii) and (iii) of the NYSE Amex Company Guide, because it has stockholders’ equity of less than $2.0 million, $4.0 million and $6.0 million and losses from continuing operations and/or net losses in two of its three most recent fiscal years, three of its four most recent fiscal years and its five most recent fiscal years, respectively. 

Now, PharmAthene has been repudiated by the Food and Drug Administration (FDA) in a letter sent to David Wright, company’s president and CEO.  The FDA claims PharmAthene has made “false or misleading statements” about one of its products named SparVax. 

The FDA statement says:

The Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) has reviewed a Product Fact Sheet entitled ‘SparVax™ – Recombinant Protective Antigen (rPA) Anthrax Vaccine-Novel Second Generation Vaccine Technology’ for your investigational product Bacillus anthracis Recombinant Protective Antigen 102 (rPA; E. Coli) (anthrax) vaccine -b(4)---.  The product fact sheet contains false or misleading statements that represent your product as safe and effective for the purposes for which it is being investigated.  This is problematic from a public health perspective because it suggests that SparVax is safe and effective when the product has not yet been approved by FDA and the promotional claims have yet to be demonstrated by substantial evidence or substantial clinical experience.  As a result, these materials misbrand your investigational product in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(a)&(n), and 321(n), and FDA’s implementing regulations.  (See 21 CFR 312.7(a)).

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