HEP, HEP, Hooray!
CDER Director, Dr. Janet Woodcock. responding to criticism about the high price of breakthrough drugs, said that the agency is working towards approving more effective treatments for diseases like cancer and hepatitis. Reacting to controversy around the price of the breakthrough Hepatitis C drug Sovaldi, Dr. Woodcock discussed the potential decrease in societal costs and increase in patients' quality of life.
"I think we have to in some ways think about this as a transition period," she said during a panel discussion about the breakthrough designation. "We may have to put a big down payment down now to get something really good."
She highlighted the cost to society and burden on patients in dealing with the side effects and morbidity of having Hepatitis C. "I really do believe we need to drive toward curing, but you have to have a transition period, she said. "We are driving toward a cure with hepatitis."
Woodcock further advocated getting these drugs on the market so they could be combined with other products to drive toward cures. "In cancer, I think we have to recognized this is version 1.0, but we're going to get there," she said. "And to get there we can't hold back. We can see that cure."
The battle for the heart and soul of 21st century health care is the battle over innovation. And nothing short of victory is acceptable. To borrow an over-used adjective from the world of global climate change, we must protect “sustainable” innovation.