Patients and patient advocacy groups are demanding faster approval for treatments they and their constituents need, and need right now. Groups more generally interested in reducing government control over drug approval are accompanying them in this mission. The target? The US Food and Drug Administration.
Getting the FDA to approve drugs faster is seen as one way to get the access that many patients and their families want. Vice President Pence and many other legislators seem to have been persuaded that the FDA is the roadblock. It isn’t. The real barrier is payers of prescription drug benefits, such as health insurance companies and self-insured employers.
The FDA of 2009 – 2014 absolutely was obstructing accelerated approvals. The uproar from patients was justified and worked. Now the FDA is more flexible and listening to patients . But PHRMA is not. They gutted the Adrea Sloan Compassionate Use Reform Act. We patients don’t believe the companies , even the small ones , cannot afford more compassionate use. They are our next focus . If they think their drugs are good enough for accelerated approval then they are good enough for compassionate access. We hold them morally responsible . All this potential access precedes the payers . We will deal with them as they try to put a price on human life.