Dealing with Emerging Technologies
“The agency charged with judging the safety and effectiveness of drugs and other medical products and monitoring the safety of those products as long as they are on the market must possess a scientific capability equal to that task and become engaged in mission-critical fields of applied research including systems biology, wireless healthcare devices, nanotechnology, medical imaging, robotics, cell- and tissue-based products, regenerative medicine, and combination products,” the report declared.
FDA will take one of its first steps in that direction next year, when it rolls out details of another key life science priority: “Strategic Priorities 2011–2015 calls for keeping up to date in new technologies while maintaining expertise in established technologies.” On this topic, at least, the report offers some more concrete thinking by the FDA.
The agency said it will “integrate genomics, proteomics, high-sensitivity gene sequencing, and other cutting-edge technologies into regulatory oversight to expedite product development and review.” Additionally, the agency said it will also use biomarkers and adaptive designs to improve its evaluation of product effectiveness in clinical trials and advance regulatory research to facilitate product review including developing relevant animal models.
“FDA will continue to work in a collaborative manner with our public, academic, and private-sector partners to meet the challenges posed by the emerging technologies,” Formanek said.
Overcoming those challenges, according to the agency, will require unspecified “program growth in emerging areas such as nanotechnology, biosensors, proteomics, genomics, and metabolomics.” Fair to say “program growth” means some combination of extra activity, personnel to carry it out, and of course the money to pay for it. But that growth will be easier said than done.