They tend to be skeptical of risky procedures and resistant to change.
In the pharmaceutical industry, however, the U.S. Food and Drug Administration (FDA) is the only possible source for manufacturing change. The drug industry is so heavily regulated, individual producers have not been able to experiment with manufacturing changes without gaining FDA approval. So innovation simply hasn’t been part of the drug industry’s business environment.
But new thinking at the FDA is bringing advances to drug manufacturing. “There’s been an infusion of new blood at the FDA over the past dozen years,” explains Alison Smith, senior research analyst at AMR Research Inc., in Boston. “Now, you’re getting people who grew up with computers and are not afraid of technology. They realize that the tools are there to improve pharmaceutical manufacturing.” Smith also notes that the FDA has an interest in supporting the U.S. drug industry. “It’s unusual for the federal government to push innovation, but they see the PAT (the FDA’s Process Analytical Technology initiative) as a way to protect our drug industry.”
The PAT initiative was a true turnaround for the FDA, say industry experts. “For decades, the FDA said pharmaceutical companies couldn’t innovate in manufacturing because of regulatory concerns,” notes Troy Logan, pharmaceutical segment manager at Siemens Energy and Automation Inc., of Alpharetta, Ga. “Until the FDA turned the tables on the pharmaceutical industry with PAT, there was no framework to bring this type of technology forward.”
John Blanchard, principal analyst at ARC Advisory Group Inc., in Dedham, Mass., sees PAT as a complete revamp of the view of manufacturing pharmaceuticals. “The FDA’s PAT [initiative] is changing the entire automation paradigm for pharma manufacturers,” says Blanchard.
See the story that goes with this sidebar: The federal government’s Food and Drug Administration
