‘Right To Try’ (Experimental Medication) Bill

[Marco]

In Colorado, a bill has passed allowing dying patients access to experimental (not FDA-approved) medication.

"House Bill 1281 gives hope to patients who are coping with a terminal illness. It's going to allow individuals and families the ability to participate in clinical trials or use investigational drugs and devices that are still pending approval from the FDA," Hickenlooper said.

It's a bill that will allow terminally ill patients to participate in clinical trials, use medication and or devices that have not yet been approved by the Food and Drug Administration. The bill is considered by many the last hope for patients who will soon die.

[AnneLouise]

Go Colorado! Again.

[football-mom]

Yay for us Coloradoans! Okay, I'm just a transplant from Kansas, but I'm very glad I live here now.

Is that just for terminal illnesses, Marco, or will chronic illnesses be accepted?

[Marco]

"Right To Try" bills also await governors' signatures in Louisiana and Missouri, and Arizona voters will decide in November whether to set up a similar program in that state. For now, these laws only affect those with terminal illnesses and not chronic illnesses. Of course, this type of legislation is often the first step in a longer process.

The legislation allows drug companies to provide experimental medications to patients outside of clinical trials. But drug manufacturers would not be required to do so. The drug manufacturers can choose whether to charge for the medication or to provide it to the patient free of charge. Insurance companies are not required to pay for the treatment and experimental drugs would not be on their approved drug lists. Can you already hear the complaints that only rich people have access to these drugs because poor people cannot afford them?

Look at the number of MS patients that believe they should be entitled to Lemtrada, even though the FDA says the manufacturer did not demonstrate benefits greater than the known risks. If those patients have negative side effects who would be responsible for their aftercare? Would the patient or their family be able to sue the doctor, drug manufacturer, hospital? I would imagine most drug companies, physicians and hospitals will be wary of this program unless there was tort reform protecting them from lawsuits. A company may have 500 million invested in a drug and any bad press could sink the drug's market potential. Would you jeopardize future medication revenue on the response of a patient already knocking on death's door?

[misslux]

Terminal only.

http://www.leg.state.co.us/clics/clics2014a/csl.nsf/billcontainers/CE8AAA4FAF92567487257C6F005C8D97/$FILE/1281_01.pdf

[fishead]

"Compassionate use" has been around for a while. It is something that must jump thru a few hoops. Hopefully, by signing these state bills, this process can be expedited.

[onlyairfare]

Fishead, you're right. For years it has been possible (but not necessarily easy) to get medications on a "compassionate use" basis if nothing else has worked, especially if the illness is terminal. It's also sometimes called "treatment of last resort."

Sometimes such use is even paid for by insurance companies, after you go through the appeals process. The process will likely get a lot easier when there is pressure from a number of states passing such laws, though there will still be federal laws and FDA regulations to overcome.

I suspect any such use is/will be accompanied by extensive legal documentation acknowledging no guarantees, "hold harmless" agreements for any adverse outcomes, and a bunch of other legalese. With small numbers, it might be as likely a pharma will be praised for "doing the right thing" trying to help a desperate patient, as they would be to be sued for damages.