Tentative approval by FDA enables generics access to poor nations, where generics are often the only drugs that are affordable for patients. This comes about via a US initiative, which allows sale of generics to treat conditions where there is a significant public health impact, even though the originator drugs are still under patent protection.

The initiative, termed ‘the President’s Emergency Plan for AIDS Relief (PEPFAR)’, was launched by President George W Bush in 2003 to fight AIDS globally. It allows FDA to carry out an expedited review process and enables the agency to issue tentative approval for generic products. This means that, although the product meets all the safety, efficacy and manufacturing quality standards, it cannot be marketed in the US, but it does qualify for consideration for purchase under the PEPFAR. The United States Agency for International Development may purchase any product that has either a ‘full’ or ‘tentative’ FDA approval for use in developing countries [1].

Epzicom is GSK’s top-selling HIV treatment and in 2010 worldwide sales of the anti-retroviral combination by ViiV Healthcare, the specialist HIV company established by GSK and Pfizer, increased by 8% to GBP 546 million.

Epzicom received FDA approval in August 2004 and its patent expires in both Europe and the US in 2016, but GSK is already fighting to keep generics competitors at bay. On 5 August 2011, ViiV Healthcare filed suit against Teva for infringing a 2002 Epzicom patent.

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Reference

1.  GaBI Online - Generics and Biosimilars Initiative. What is ‘tentative approval’ and how does it affect generics? [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Generics/General/What-is-tentative-approval-and-how-does-it-affect-generics