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Brand-name FDCs and PEPFAR, 2004


September 2004

By Rob Camp

In January 2003, W announced PEPFAR, The President's Emergency Plan For AIDS Relief, pledging 15 billion dollars of funding over 5 years, to provide testing and treatment in 15 countries affected by HIV/AIDS. Critique of PEPFAR has highlighted several things, including the narrow focus on 15 countries, and the requirement that PEPFAR funds only use brand-name ARVs in the treatment programs initiated in these countries. Since brand name drugs are prohibitively expensive—even after countries negotiate with the companies for discounts—and PEPFAR treatment funds are relatively low, excluding generics from the PEPFAR treatment plan means that far fewer people will have access to life-saving treatment than is possible with the use of generics.

In May 2004, as a component of PEPFAR, HHS announced an expedited FDA review process for antiretroviral fixed dose combination (FDC) products. The expedited review shortened the time to weeks, and was designed to encourage companies to invest in the development of fixed dose (creating one pill out of two or three individual drugs), co-packaged (putting two or more pills into single packaging for distribution) antiretroviral drug products.

Right now, PEPFAR is a unilateral (can you say go-it-alone?) process, which is both duplicative and unnecessary because there is international consensus supporting the GFATM that uses the WHO prequalification process.

The existence of these brand-name two-drug FDCs doesn't necessarily translate to access and availability if the drug itself is not affordable. For example, although Gilead has announced an "at-cost" pricing (no mark up for profit) for Truvada in the 68 least developed countries according to the UN, the reduced price remains higher than what these countries can now afford to pay for a triple regimen. According to the Economist, workers in at least 45 of these 68 countries make about $1/day. This partial treatment would cost 99¢. If the third drug costs more than a penny a day, millions won't be able to access it (and eat). Back to generics.

Generic competition is the most effective means of reducing drug prices, but both TDF and FTC are under patent. Therefore, generic versions of these products couldn't be considered by FDA under their "expedited approval process." All makers of FDCs, right now Gilead and GSK, should promise not to sue generic drug makers in other countries and also release PK, stability and manufacturing data so these companies can reference this for the WHO prequalification process.

PEPFAR right now restricts generic versions of products such as these, and can't even consider approval of generic versions of abacavir, lamivudine, emtricitabine or tenofovir, or any product that combines any of them, because of the "data exclusivity"1 that is in effect in the US on those drugs. In other words, the US is discouraging generic competition for these products, although dramatic and sustained price cuts have only been possible through generic competition.

The FDA has announced that the existence of FDCs will facilitate access to these drugs in developing countries. The rejoinder might be—at what price, both economically and strategically?

An FDC that combines all needed ARVs into one pill is ultimately preferable; the American FDCs are not stand-alone combinations—they still requires additional ARV(s) in order to constitute an effective regimen, vs the WHO pre-qualified triple combinations, which are complete treatments.

1. Data exclusivity prevents a regulatory authority from relying on original (pharma company) data for a set period, during which no authorisation of medicines similar to those of the original applicant may take place on the basis of the original tests. The "copier" (usually a generic drug manufacturer) is then obliged either to produce its own tests or to wait until the exclusivity period has expired.

James J, 8.28.04, electronic communication,

Russell A, Health GAP,,