The benefits of the FDA's fast-track ARV approval

Four years ago, the FDA announced it would test and certify as a true generic, for free, any ARV manufactured by a foreign company.  This fast-track certification asks a copy drug to prove that it is bioequivalent to the original drug.  If a copy drug is not bioequivalent, it may act on the body in subtly different ways, increasing the chances of clinical failure and viral mutation.

The FDA announced this fast-track offer at the same time as the WHO's infamous de-listing of 18 ARVs from its prequalification programme in May 2004. The prequalification programme, incidentally, is not a regulatory programme and does not require the same high standards as the FDA. 

This sets a double standard:  drugs approved by WHO prequalification are not demonstrably bioequivalent, and would therefore not be used in developed countries.  So, patients receive these drugs because they are poor rather than because they are sick.

As this briefing note over at the CFD shows, the FDA fast-track approval scheme has gone some way to rectifying this double standard.