The New Payer Dogma: US FDA Approved Drugs Have 'Less Evidence'
It is now a common assertion among insurers that one of the many challenges they face in covering high-priced specialty therapies is that drugs are approved with “less evidence” than used to be the case. That is more myth than reality – but a very dangerous myth if it isn’t corrected by the US FDA and the drug industry.
You may also be interested in...
Government Accountability Office also finds that US FDA review divisions are largely consistent in their assessment times after controlling for goal dates and expedited programs.
Richard Pazdur, FDA's oncology chief, reiterates the breakthrough therapy designation is for agency-sponsor communication and not an investor tool.
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."