Press Release Regarding Abbott's New Pediatric Formulation - Abbott's Greed

Press Release Regarding Abbott's New Pediatric Formulation

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[edit] Coalition of AIDS Activists: Abbott Pediatric Formulation Leaves Thai Kids Out – Delays Expected for Others in Developing Countries

  • State that development in formulation of Kaletra is a step in the right direction, but raise concerns about drug accessibility


CONTACT: Caiti Schroering 541-990-0472, caiti@abbottsgreed.com

Washington, D.C. – Abbott Laboratories announced on Friday that it applied to the European Medicines Agency (EMEA) and to the U.S. Food and Drug Administration (FDA) for approval of a pediatric formulation of its critical AIDS drug Kaletra and [[Aluvia] (which is the heat stable form of Kaletra). While the development of a pediatric formulation is a welcome step, AIDS activists are concerned that this product will not be made available to children in Thailand. Abbott's recent action in April to not register new products in Thailand means that this new formulation of Kaletra will not be registered and made available in Thailand. Activists also question whether the drug will be accessible and affordable to the 2.3 million children under the age of 15 are living with HIV/AIDS worldwide because of delays in seeking registration, as well as the high price of the product.

A coalition of AIDS activists including HealthGAP, Global AIDS Alliance, the American Medical Student Association, and the Student Global AIDS Campaign has demanded that Abbott formulate a pediatric version of Kaletra. As such, today's announcement is a small step forward. Abbott claims that it will eventually make this formulation available in 150 lower- and middle-income countries. In addition, the company states that in all of the countries where this drug will be available, it will be at half the cost of the full-strength tablet.

Still, Abbott's promises are insufficient. The company must take several important steps to ensure its drugs are globally accessible. “By registering the drugs with only the American and European drug regulatory agencies, Abbott neglects the majority of world's HIV+ children. Abbott must do everything in its power to file for registration with individual countries' drug regulatory agencies,” states Moriah Silver of the Student Global AIDS Campaign.

Activists demand that Abbott:

  • Register the pediatric, heat-stable Kaletra in Thailand. Abbott's new-product boycott policy in Thailand means that Thai children will be denied access to this new, life-saving formulation. Abbott pulled the registration for heat-stable Kaletra in Thailand this spring after Thailand issued a compulsory license for it.
  • Publish a timetable for registering this new formulation in developing countries. Currently, there is no true commitment to a timetable for filing for registration in the 150 countries – and they still have not announced a timetable for worldwide registration of their adult version of heat-stable Kaletra.
  • Commit to putting people above profits – pediatric Kaletra will be sold for $250 in Africa (a "no-profit" price) but for $500 in other low and lower-middle income countries. Many of the people (and children) in need of Kaletra in low and lower-middle income countries live on less than $2 per day, so it is not acceptable for Abbott to make a 100% profit on the lower-middle income countries.