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Lobbying For Cuba in DC, Healiance Pharmaceuticals

The Cuban government has once again successfully navigated the halls of power in Washington, DC. The Miami Herald is reporting this morning that several Members of Congress will  send a letter to the Treasury Department requesting that a license be granted authorizing the import from Cuba of a diabetes treatment for foot ulcers called Herberprot-B.

The drug appears to have been developed at a facility with suspected links to Cuba’s bioweapons program, the Center for Genetic Engineering and Biotechnology (CIGB). While this should matter, I doubt it will. CIGB bioterror links have been hotly debated in this town for many years and, most of the time, people ignore or try to downplay the connection.

So, what else do we know? Of course, there is the money. A lot of it.

New Jersey-based Healiance Pharmaceuticals is the lead U.S. company on the project. Healiance is the U.S. subsidiary of an obscure German company called Graffinity Pharmaceuticals. During the course of the last two years, Healiance has retained a few lobbyists including:

  1. Former Congressman Bill Delahunt (D-Mass.) — note that his lobbying report says he is working on “medical innovation”. He fails to mention any links to the Cuba project. Rep. Delahunt is a long-time advocate on easing all economic sanctions on Cuba.
  2. The Gephardt Group‘s Janice O’Connell — note that this lobbying report filed two years prior to Rep. Delahunt’s report says that she is working on the exact same thing, “medical innovation”. As with Delahunt, she does not list any links to the Cuba project.  O’Connell is a sharp policy and political operative. A former Senate Foreign Relations Committee staffer, as with Delahunt, an opponent of current U.S. policy toward Cuba.

According to the Herald, there is at least one Republican on board: a top advisor to the Romney for President campaign, former New Hampshire Governor and White House Chief of Staff to George H.W. Bush, John Sununu.

For fellow regulatory lawyers and politicos, securing an OFAC authorization for the import of this drug may not be as difficult as it used to be. The issue is not the OFAC license, rather it is the public safety component and numerous FDA regulatory hurdles imposed by the Federal Food, Drug, and Cosmetic (FD&C) Act and other laws. None of this is cheap. It takes a great deal of time and money to get it right.

But wait, there is more.

An old but still in force law with regards to Cuba, the Trading With the Enemy Act (TWEA), as well as the national emergency with respect to Cuba in place since the late 1990s, poses significant legal hurdles to the proposed transactions. I will talk some more about these challenges in a future post.

For now just keep in mind that if Cuba is going to benefit economically from these transactions, it may be illegal. If the Obama Administration can find some loophole and manage to license the sale of this Cuban drug, the proceeds from the sale or manufacture of this medicine should be used to pay for pending claims against Cuba such as certified property claims and many more recent judgements.

Even if the drug is never sold in the United States in  the near term, the regime still benefits. Accessing the U.S. market, even if just for FDA testing, is a money-making event. You see it can be used for marketing purposes to boost Herberprot-B sales in other markets. This would, in turn, directly benefit the Cuban regime.

Stay tuned, I expect a lot more news on this story and related Cuba efforts to ease sanctions. While not a subject reported on the mainstream news, there is a lot taking place these days in DC and throughout the United States that does not bode well for supporters of U.S. sanctions.

Here is a video prepared by Cuban state media on the Herberprot-B treatment:

And here is a 2007 video that includes Janice O’Connell, one of the lobbyists that may be working on Healiance Cuba project. Note her comments on U.S.-Cuba policy:

  • carolinaprettyface

    CANADA’S YORK MEDICAL HAS BROTHER OF CUBA’S VICE PRESIDENT ON BOARD
    OF DIRECTORS- In what competitors are describing as “a brilliant political
    move,” Mississauga, Ontario, Canada-based York Medical, Inc., has elected
    Dr. Agustin Lage Davila, Director of the Republic of Cuba government-operated
    Centro de Inmunologia Molecular, as a member of the Board of Directors
    of York Medical. Dr. Agustin Lage Davila is the brother of H.E. Dr.
    Carlos Lage Davila, a Vice President of the Council of State of the Republic
    of Cuba, who H.E. Dr. Fidel Castro Ruz, President of the Republic of Cuba,
    recently named as one of his possible successors. York Medical has
    agreed to pay CIMAB S.A., a corporation representing Centro de Inmunologica
    Molecular, US$8,830,000.00, of which US$1,299,500.00 has been paid, US$1,230,500.00
    is scheduled to be paid in 1999, and payment of the remaining US$6,300,000.00
    has yet to be scheduled. Another politically-connected member of
    the Board of Directors of York Medical is The Honorable Mark Entwistle,
    the immediate past Ambassador of Canada to the Republic of Cuba, where
    he served from 1993 to 1997.

    ———————————————————————————-

    http://pharma-alliance.com/qualityandcompliance.html

    Quality & Compliance

    Quality and
    compliance is business critical. Our quality and compliance network offers a
    wide range of services, from site and product reviews, risk assessments and due
    diligence work, through to integrated validation programmes for products and
    processes. The group is built around a strong nucleus of experienced
    professionals and qualified persons (QP’s).

    Pharma Alliance maintains a wide range of quality data for
    quality operations that provides a productivity and cost targets by technology
    stream.

    We focus on the organisational challenge of defining and aligning
    appropriate quality functions and services to meet development and manufacturing
    objectives.

    8 service streams
    …….

    • Validation – new facilities,
    processes & products
    • Risk
    Assessment
    • Validation –
    retrospective<
    • Due diligence
    • Project Management
    • Technology
    & product transfer
    • Site & Product
    reviews
    • GLP and GMP standards

    Proven methodologies, skills & results
    …….

    • Pfizer performance review of global
    quality
    operations
    • Novartis alignment of
    quality services to production
    operations
    • Smiths Medical validation
    programme
    • YM biosciences assessment & audit
    of manufacturing
    facilities
    • Wyeth focused factory
    design

    ———————————————————————————–

    So YM Biosciences is also York Medical, who has been working with the Cuban governments for awhile, and now they have clearly gotten to some of our politicians. Their agenda is clearly to dissolve sanctions and begin doing business with Cuba again. They tried ending the embargo when our US oil companies were biting at the bit to get in Cuba, and now that no oil has been found, they have another agenda to use for ending the embargo without political change. Please know that even though it appears that this is all being done for the good of mankind, but it's just another PR campaign to end the embargo without addressing the issues, such as the American Stolen Properties, and the oppressive regime that wants to continue to enslave the people of Cuba. The claimants will be forgotten, if Castro has his way. Please don't let these people end the embargo without concessions. When some of these folks tried to buy my US Certified Cuban Claim back in 2007, it was clear that their agenda was to help the Castro brothers! They want to screw us over again, and don't let that happen. Please feel free to comment, if you are a claimant!

  • carolinaprettyface

    CANADA’S
    YORK MEDICAL HAS BROTHER OF CUBA’S VICE PRESIDENT ON BOARD
    OF
    DIRECTORS- In what competitors are describing as “a brilliant
    political
    move,”
    Mississauga, Ontario, Canada-based York Medical, Inc., has elected
    Dr.
    Agustin Lage Davila, Director of the Republic of Cuba
    government-operated
    Centro
    de Inmunologia Molecular, as a member of the Board of Directors
    of
    York Medical. Dr. Agustin Lage Davila is the brother of H.E. Dr.
    Carlos
    Lage Davila, a Vice President of the Council of State of the Republic
    of
    Cuba, who H.E. Dr. Fidel Castro Ruz, President of the Republic of
    Cuba,
    recently
    named as one of his possible successors. York Medical has
    agreed
    to pay CIMAB S.A., a corporation representing Centro de Inmunologica
    Molecular,
    US$8,830,000.00, of which US$1,299,500.00 has been paid,
    US$1,230,500.00
    is
    scheduled to be paid in 1999, and payment of the remaining
    US$6,300,000.00
    has
    yet to be scheduled. Another politically-connected member of
    the
    Board of Directors of York Medical is The Honorable Mark Entwistle,
    the
    immediate past Ambassador of Canada to the Republic of Cuba, where
    he
    served from 1993 to 1997.

    ———————————————————————————-

    http://pharma-alliance.com/qualityandcompliance.html

    Quality
    & Compliance

    Quality
    and
    compliance
    is business critical. Our quality and compliance network offers a
    wide
    range of services, from site and product reviews, risk assessments and due

    diligence
    work, through to integrated validation programmes for products and
    processes.
    The group is built around a strong nucleus of experienced
    professionals
    and qualified persons (QP’s).

    Pharma
    Alliance maintains a wide range of quality data for
    quality
    operations that provides a productivity and cost targets by technology

    stream.

    We
    focus on the organisational challenge of defining and aligning
    appropriate
    quality functions and services to meet development and manufacturing
    objectives.

    8
    service streams
    …….


    Validation – new facilities,
    processes
    & products

    Risk
    Assessment

    Validation –
    retrospective<

    Due diligence

    Project Management

    Technology
    &
    product transfer

    Site & Product
    reviews

    GLP and GMP standards

    Proven
    methodologies, skills & results
    …….


    Pfizer performance review of global
    quality
    operations

    Novartis alignment of
    quality
    services to production
    operations

    Smiths Medical validation
    programme

    YM biosciences assessment & audit
    of
    manufacturing
    facilities

    Wyeth focused factory
    design
    ———————————————————————————–
    So
    YM Biosciences is also York Medical, who has been working with the Cuban
    governments for awhile, and now they have clearly gotten to some of our
    politicians. Their agenda is clearly to dissolve sanctions and begin doing
    business with Cuba again. They tried ending the embargo when our US oil
    companies were biting at the bit to get in Cuba, and now that no oil has been
    found, they have another agenda to use for ending the embargo without political
    change. Please know that even though it appears that this is all being done for
    the good of mankind, but it's just another PR campaign to end the embargo
    without addressing the issues, such as the American Stolen Properties, and the
    oppressive regime that wants to continue to enslave the people of
    Cuba. If you are a claimant, don't just let these politicians end the embargo without consideration to us. Please contact your representatives and let them know that we should not be tricked into ending the embargo.

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