CDER Director Woodcock says pricing and approval issues are becoming "conflated" but it is hard to change people's minds when they are "determinedly angry about something."

States are eager to try more aggressive methods to rein in prescription drug costs under Medicaid, and CMS is willing to be flexible in permitting innovative contracting. But the agency is also quietly but firmly making clear that all FDA-approved drugs have to be treated the same.  

The Institute for Clinical and Economic Review is launching an initiative to adapt its value assessment approach to orphan and ultra-orphan drugs, including a possible consideration of what should be a fair return on investment for manufacturers.