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    Brazilians boiling, blaming Big Pharma for new FDA office in Brazil

    MINAS GERAIS — Brazilian officials are in Washington, D.C., today to speak with the Food and Drug and Administration to attempt to get them to change their minds about building an FDA office in Brasilia.

    In what Brazilian magazine Epoca is calling the first speed bump in President Dilma Rousseff’s dealings with the United States, the U.S. announced on April 26 it’s plans to build an FDA office in Brasilia – a move Brazilian officials are saying was never discussed with them.

    Brazilian officials consider the move an insult, as Brazil already has a food and drug agency – ANVIA – that has proved to be effective and regularly shares information with the FDA, as well as the fact that Brazil does very little in the way of exporting medicine into the U.S.

    “We were surprised. I ordered a personal email from the head of the FDA, Margaret Hamburg, telling our unhappiness with this disrespectful situation,” President of Anvisa Dirceu Barbano told Epoca. “The direction of ANVISA does not allow a foreign agency to do similar or equal work to ours in Brazilian territory. If this happens, ANVISA could be discredited internationally.”

    Former Brazilian Secretary of Health Jose Agenor Álvares insinuated that the move is being made in part for pharmaceutical companies to lobby against current Brazilian patent laws.

    “Viewing it from the American side, this is being done for lobbying reasons. To try, for example, to speed up authorizations for the American medicine sales,” Álvares told Epoca.

    President of the Association of the National Pharmaceutical Laboratories (Alanac), Fernando Marques told Epoca the reason for the office was to defend U.S. business interests in Brazil.

    “They want to prolong patents of the remedies that they win in the next years and to continue to get millions from the Brazilian government,” he told Epoca. “The manufacture of cheaper national generic and similar remedies will be fought.”

    Brazil’s patent laws have long been an issue for pharmaceutical companies. In 2007, Brazilian authorities broke a patent from Merck, and began to sell a cheaper version of the AIDS drug Efavirenz. Brazilian authorities have made it a practice in the past to allow for generic drugs far earlier than in the U.S. Last summer, Pfizer, the world’s largest drug maker, acquired 40 percent of Brazilian generic pharmaceutical firm Laboratorio Teuto Brasileiro.

    Brazilian authorities are especially irritated that the U.S. is putting them into a category with such countries as Mexico, China and Jordan, believing they have had a better record and that the move could hurt exports coming from Brazil.

    A spokesperson for ANVISA said that they could not comment on the matter while diplomatic meetings were ongoing. A spokesperson for the FDA has yet to respond to a request for information on this subject.

    The announcement of the new office in Brasilia was made on April, 26.

    The FDA has rounded out its global foothold and selected all the international office locations that can be sustained with existing funding levels, with the agency recently obtaining approval from the State Department to send staff to the economically thriving Brazil. As the agency also prepares to deploy its employees to a satellite office in the Middle East, the so-called Arab Spring has not stymied the opening of an FDA site in Amman, Jordan.

    Lumpkin added that the recently enacted food safety law also provides FDA with the first “congressional blessing” for the establishment of international offices, even though FDA could – and did – enact these sites through its existing authorities. Section 308 of the new law, which authorizes the establishment of foreign offices.

    “We now read this as the congressional [mandate] that FDA be an organization outside the United States,” he said Tuesday (April 26) at an Alliance for a Stronger FDA membership meeting. “It’s now been established as a statutory mandate for us by Congress.” …

    Lumpkin said the State Department recentlyapproved the establishment of an FDA site in Brazilia, the capital of Brazil. That facility will complement FDA’s offices – either already established or nearing finalization – in China, South Africa, India, Jordan, Mexico, Chile and Costa Rica.

    In September 2010, the Brazil and the U.S. signed a confidentiality deal:

    (ANVISA) is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding ANVISA-regulated products as part of cooperative law enforcement or cooperative regulatory activities. ANVISA proposes to share non-public information regarding, among other things, the safety, effectiveness, or quality of ANVISA-regulated products with the FDA.

    This Commitment is intended to strengthen communication between ANVISA and FDA to enhance their ability to protect and promote the health and safety of their respective populations with respect to products within the regulatory jurisdiction of ANVISA and FDA.

    Earlier this month, The House voted to block a $147 million annual payment to Brazil’s cotton industry.

    Brazilian journalist Laura Albernaz Arantes contributed to this report.


    Crossposted at William K. Wolfrum Chronicles


    I do not understand this at all!

    I mean, we can certainly send folks from State down to a foreign country to work with foreign officials in order to research matters related to exports and imports.

    Should we set up a HUD in Argentina? Or a Department of Ed in Laos?

    It is news like this that turns me more and more into an isolationist!

    Sorry man, your comparison of an FDA office with HUD and the Department of Education is ridiculous.  You don't import/export housing or education.  Some of us want to make sure that imported food, medications, etc. are safe for consumption and aren't manufactured in the same complex as a sewage processing facility.  Just a thought!  But hey, let's just be isolationists and not worry about it, eh?

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