Though not a manufacturing issue per se, Congressional lobbying is one of its great influencers. Our mention last week of VaxGen's experience in the mid-2000s--in which government funds for an anthrax vaccine were terminated in the final drug approval stages, with dire consequences for the company--is one that still incites strong responses from both the government and the biotech industry.
Peter K. Watler, principal consultant and CTO at Hyde Engineering + Consulting, provides an excellent perspective on behalf of the latter, especially small biotechs struggling against a well-funded competitor, the undefined timeframes of the drug approval process, and its high cost. "VaxGen was a small company and did a more than competent job of developing the anthrax vaccine," says Watler via email. He suggests as a chronicle the 2007 report of an LA Times investigation, conducted while the dust was still settling, which provides far more detail than the New York Times summary article we cited last week.
But our main point remains: vaccine makers need to respond quickly and enthusiastically to HHS secretary Kathleen Sebelius's mandate for weeks-long vaccine production technology, and take control of the process before anyone else does.