Bill 481: A Case Study

Insurance companies wouldn’t have to pay additional costs because once patients sign the release form patients are then responsible to pay for the investigational drugs at market costs. House bill 481 also includes all devices and procedures. In order for patients to be able to qualify for The Right to Try they must be deemed with a terminal illness and have exhausted all possible avenues before they are allowed to try investigational drugs in phase 2 of the 3 phases of FDA procedures. That is if the bill is to be passed then patients must fall under these stipulations. Once Representative Wintrow finished addressing the house committee she introduced Dr. James Quinn.
DR. James Quinn Dr. James Quinn has been involved with clinical research in Idaho and Salt Lake City, Utah for the majority of his life. Although, Dr. Quinn has recently retired from clinical work he still keeps up with material that pertains to clinical research and is extremely passionate when it comes to House bill 481. Dr. Quinn expressed his passion as he talked about the importance of getting House bill 481 passed. Dr. Quinn described the three phases of the FDA in great detail. Phase 1 is the testing phase of the drug. During this phase test subjects take the drug,
might be able to contact the FDA through a program called Compassionate Right to Use, which permits Dr.’s the ability to acquire test drugs that are in phase 2 or 3 of the FDA. However, this can take 2-4 months of navigation and the paperwork alone takes 100 hours to fill out. Legislators met Feburary 20th of 2015 to see about getting the paperwork times reduced to just 45 minutes, but 1 year later the bill that was trying to get the paperwork reduced still hasn’t moved any further then when it was introduced. Once again, patients and families don’t have months to waste waiting for their Dr.’s to establish clinical trial