The FDA’s director of drugs, Janet Woodcock, believes the movement toward comparative effectiveness research will lead to a more internationally harmonized drug development process. Speaking at the Food and Drug Law Institute’s annual meeting in April, Woodcock said that as comparative effectiveness data become more standard and relied upon by national payer systems and insurance companies, related clinical study principles will be forced into the development program.
“So the development program is going to be expected not only to accomplish demonstrated effectiveness but also have more input in placing the drug in the armamentarium and deciding the value of the therapy,” she said. Regulatory authorities will not be the ones mandating changes to drug development programs, Woodcock said—instead, it will be driven by national payer systems and insurance payers.
“So I think there is going to be a period of transition over the next 10 years and we are going to see a very different approach to development programs.”