"There is no FDA commissioner, no champion for the agency right now," Toth says. "For the first time in four years, in 2000 the FDA spent a long time in reviewing and approving new drugs. It was a pretty dramatic slippage. Biotechs, in particular, depend on rapid drug approvals from the FDA, because they do not have the large cash reserves to finance lengthy drug discoveries, according to Toth. The biotechs are affected to a greater degree than the big pharma companies, [because] they tend to try and get their drugs approved on less data."
Once a drug has been approved, companies can easily spend $250 million or more to build production facilities, and investors are reluctant to provide the funding until the approval is assured. Meanwhile, both big pharma and small biotech companies continue on the mergers and acquisitions track in the race to overtake their competitors in AIDS, ...
