AIDS drugs hit roadblock in Africa, Dispute over generics stalls treatment efforts is the lead story in today’s Boston Globe. Nigeria, Uganda, Ethiopia, and Tanzania won’t accept FDA approval for generic anti-retroviral drugs made by Aspen Pharmacare of South Africa. Instead, they want World Health Organization approval. The dispute is threatening the supply of AIDS drugs in Africa. It’s a real problem, because the supply of branded drugs has not kept up with demand. So in addition to being cheaper, generics are required to meet existing needs.
Obviously there’s more to the story than disagreements over scientific review standards. The individual countries prefer to retain autonomy, rather than be regulated by the US. They have long-standing relationships with WHO and none with the FDA.
The WHO is quite dysfunctional, and much of the criticism by the US is justified, however the US side has also been quite arrogant. It’s a real problem for the companies that are caught in the middle –they have to devote extra time and money to achieve registration in each country. And obviously it’s a problem for patients.
As I’ve mentioned before, the Forum for Collaborative HIV Research has played a key role in getting multiple regulatory agencies, companies, and activists in the same room in order to coordinate their agendas and foster cooperation. We may need the Forum to step into this mess.June 20, 2005