Capitol Hill continues to shake up details of consumer drug access
Where does your facility stand on ‘Right to Try’?
Excited about the recent Rx revolution? Keep up to speed with your weekly fix from SpecialtyRx For years, federal and state governments have gone back and forth on the debate over experimental medical treatment. Although clinical trials have brought profound relief to plenty of patients, they represent a miniscule fraction of the millions of people suffering from debilitating terminal conditions. Those of us in long-term care know the issue well.
Now, the ‘Right to Try’ Bill is making headlines again thanks to Senator Ron Johnson (R) of Wisconsin. The lawmaker sent a public plea to the FDA essentially ordering them to ‘step aside’ and allow terminally ill patients timely access to Phase I trial drugs and therapies. Trump is spearheading the alternative pathway with help from the Department of Health & Human Services. Many consider the bill’s signage a highly promising bipartisan victory.
Fight for life—or feel good legislation?
For people diagnosed with deadly diseases, the FDA’s ‘compassionate use’ program sounds like a viable option. However, ‘Right to Try’ advocates say very few patients ever gain clearance. Trump’s bill strives to squash the red tape, speed up the application process, and give sufferers a fighting chance at life.
Opponents siding with the FDA fear for patient safety and warn against con artists cropping up as a result of the bill’s lax measures. Politics aside, have you thought about the pros and cons? How many of your patients would benefit from faster, more affordable access to trial drugs? These are important questions to consider.
Until next time, check out the following facts surrounding ‘Right to Try’ and the baseline requirements for patient qualification.
The road to reprieve
in 5 easy steps:
1. The patient is not only terminal, but has also exhausted
all other available treatment options
2. Without any other avenues for treatment, the patient’s
physician has officially recommended experimental
3. The drug they are seeking is currently under
consideration by the FDA and has passed the
preliminary testing phase
4. The patient acknowledges any and all potential risks
and has given consent
5. The drug manufacturer is ready, able and willing to
provide the product to the patient