Latest posts by Christine Herrin (see all)
- FDA’s Broken Drug Approval System Continues Hurting Patients - February 12, 2020
- Millions Continue to Suffer from Alzheimer’s While FDA Lacks Efficiency - December 5, 2019
- The Real Horror is the FDA’s Drug Approval Process - November 11, 2019
Americans suffering from debilitating diseases should not have to lobby Congress or Food and Drug Administration (FDA) bureaucrats for special permission to access potentially lifesaving treatments, yet that’s the situation many patients are in.
Consider Jaci Hermstad, a 25-year-old Iowan who suffers from a rare form of ALS. Hermstad has been fighting for her life for months, but has found hope in a groundbreaking molecular therapy developed specifically for her. It seems like common sense that Hermstad should be able to access this innovative, highly specialized treatment before it is too late. However, in the upside-down world of the FDA drug approval process, common sense no longer applies.
It takes, on average, 12 years and $2.9 billion to bring a drug from lab to market. For thousands of Americans, this is far too long.
Even though Hermstad’s life hangs in the balance, FDA’s drug approval process is not currently able to test and approve medicines quickly enough for the new molecular therapy to matter for Jaci. Until just weeks ago, it looked as though Hermstad would almost certainly die while waiting for the FDA to grant her permission to access a procedure that could save her life.
Fortunately for Jaci, she has received overwhelming support from the public and Congress with a recent bill introduced on her behalf, H.R. 2855. This legislation, called “Jaci’s Bill,” would provide access for Hermstad and suffering patients like her to seek molecular therapy by way of a compassionate use request.
The pressure put on FDA by Congress and the public has helped her story reach thousands of people. Thankfully, in the wake of public demands, the FDA has announced it will allow Jaci to access the medicine that could save her life.
However, not everyone is so lucky, and it’s unrealistic to expect every person suffering in pain to create a vast public campaign resembling the effort that led to Jaci’s victory. No patient should be forced to fight for access to a treatment he or she should have every right to access in the first place. Jaci is not the first or the last American to be diagnosed with a terminal or debilitating disease.
Thankfully, there is a public policy solution that would streamline the antiquated drug approval process: Free to Choose Medicine. Under a Free to Choose Medicine track, patients would have the ability to access potentially life-saving medications—at the discretion of the drug manufacturer, doctor, and patient, not FDA bureaucrats.
Free to Choose Medicine would allow thousands of patients to access needed drugs sooner and at a lower cost, all while protecting patients’ right to pursue medications that could improve or save their lives.
It is truly a blessing FDA reacted positively to the public outcry about Jaci’s story, but what about next time? What about the thousands of others suffering while they wait for FDA to act? We must press for reform now, before it’s literally too late for dying patients.
[Originally Published at Townhall]