Culberson Statement on Right to Try Act
by John Culberson on May 25, 2018 at 2:51 PM
I issued the following statement after the Right to Try Act passed the House.
“This bill is for families that have tried every available option to help a terminally-ill loved one. In 2013, I met a young woman from Texas with terminal ovarian cancer. I tried to help her get access to alternative treatments that were not yet approved by the FDA. Unfortunately, she passed away before she could get the help she needed.
“Just like her, others suffering today deserve the right to try alternative treatments right here at home, and this bill will grant them that option.”
Right to Try:
- Creates a new alternative pathway for patients to access experimental drugs and gives terminally ill patients access to unapproved drugs through their doctor
- Requires patients to provide informed consent to access unapproved drugs
- Guards patients from manufacturers purposefully misbranding or mislabeling drugs
- Provides liability protections for doctors, manufacturers, sponsors, clinical investigators, and hospitals; unless there is a reckless or willful misconduct, gross negligence, or an intentional tort
- Requires manufacturers to publish annual reports on the use of unapproved drugs
- Products must have completed a Phase 1 (safety) clinical trial.
Read the Right to Try bill text here.