Corporate accountability: Abbott pressed to make new anti-AIDS drug accessible, affordable

In October 2005, the U.S. Food and Drug Administration approved a new formulation of Abbott Laboratories’ anti-retroviral drug Kaletra. The World Health Organization (WHO) has recognized this anti-AIDS drug, a tablet formulation of two protease inhibitors, Lopanavir and Retrovir, as an “essential medicine.” It will be included in the WHO’s revised antiretroviral treatment guidelines, in which boosted protease inhibitors represent the cornerstone of second-line therapy (after resistance to initial medications occurs). This new version of Kaletra can be stored without refrigeration. However, as of this writing, the drug is only available in the United States.

When Doctors Without Borders/Medecins sans Frontieres (MSF) inquired about the price and availability of this new product for its patients and placed an order in March 2006, Abbott responded that it would wait until the product was available in Europe before requesting marketing approval in developing countries. This means a potential delay of years before this drug reaches the people who can benefit from it most.

Abbott requested proof of special import authorization from the countries where MSF intends to use the drugs. Yet, says MSF, “this creates an impossible situation, as some countries will not even begin processing special authorization until they are provided with an order confirmation. There are no regulatory or legal barriers that prevent Abbott from fulfilling the order: Abbott can ship the drugs at the same time as MSF works on getting the authorizations, which it does under its own responsibility.”

Abbott has suggested that access to the old version of the drug should be sufficient until Abbott makes the new drug available in developing countries. According to MSF, “this is unacceptable, as it could take years, and the old version, which needs refrigeration, is unsuitable for use in many countries where MSF works.”

The company later stated that it has filed to register the drug in South Africa, and announced a price of US$500 per patient per year in African and least developed countries. It did not disclose its price for middleincome countries. As of early April, Abbott has not given MSF a confirmation as to when it will fulfill MSF’s order for this medicine for use in developing countries.

On April 5, more than 200 public health experts and advocacy groups, led by UN Special Envoy for HIV/ AIDS in Africa Stephen Lewis, wrote to Abbott CEO Miles White to express concerns about the lack of availability of Kaletra, known by its medical abbreviation LPV/r, in developing countries. The letter urged Abbott to take the following actions to make this crucial new drug accessible:

“1. Immediately file for registration of the new LPV/r formulation in all countries where the old formulation was registered or pending, as well as in other developing countries. The old version of LPV/r is registered in 55 countries and registration is pending in 13 others, covering 68 of the 69 countries eligible in Abbott’s Access Program. But the new formulation of the drug has not been registered in any country except for the U.S.
“2. Communicate the countries and the filing dates where registration of the new formulation of LPV/r is pending and a timeline for submissions to remaining countries… so that health advocates in these countries can work with national drug regulatory authorities to overcome any delays and provide a timeline for submitting remaining registration requests.

“3. Establish a price that is at least as low as the price for the old formulation in least-developed countries ($500 per patient per year). Abbott’s Access Program for the old formulation of LPV/r excludes middleincome countries, resulting in prices up to 12 times more than in least-developed African countries. We urge you to make the new formulation available at an affordable price in middle-income countries where millions live on less than US$2 per day.

“4. Develop a pediatric formulation of the new formulation of LPV/r. WHO draft pediatric guidelines recommend LPV/r for use in children if there is coldchain access. While this new formulation overcomes the storage challenges presented by the old formulation, care-providers would not be able to cut or crush tablets because the new LPV/r is a coated tablet. Therefore, care providers need a pediatric version of this formulation so that they can provide adequate second-line regimens for children as well as adults.

“5. Work with countries to make the new formulation of LPV/r easily available while registration applications are being considered. Because the drug registration process can take months if not years to complete, we ask that Abbott establish a reliable interim system to distribute this new formulation to treatment programs in developing countries while registration is pending.”