Posted by Michael Wonder on 17 Sep 2017
Cheaper drug trials would lower prices: FDA chief
15 September 2017 - Decreasing the time and cost it takes to develop a drug would lower drug prices, FDA chief Scott Gottlieb said 11 September.
If drug makers used combined-phase—also called seamless—trials, rather than the traditional three phases of study, they would save time, cut costs, and reduce the number of patients who have to enroll, Food and Drug Administration Commissioner Gottlieb said. Seamless trials are increasingly being used for oncology drugs, and the FDA’s Oncology Center of Excellence is taking steps to better evaluate and cultivate this approach, he told attendees at a conference hosted by the Regulatory Affairs Professionals Society.
Developing a new drug takes 10 to 15 years and costs an average of $2.6 billion, Andrew Powaleny, director of public affairs at the Pharmaceutical and Research Manufacturers of America, told me.
