I realize everyone is in a tizzy over the Secretary of State shuffle, but Congress is back to work and there’s a vote today on a rather important bill. It involves actual improvements to healthcare rather than the usual political battles. House Majority Leader Kevin McCarthy sent out an announcement about it yesterday, and if passed, it will allow easier access to experimental drugs for terminally ill patients who have run out of conventional options.
“We are a resilient and resourceful nation, and when faced with long odds, Americans should be given the opportunity to harness our country’s vast medical innovation by accessing experimental treatments. As President Trump said in his State of the Union, and as Vice President Pence has long advocated, no one should have to look beyond the United States and our world-class health providers for hope. This bill was subject to months of negotiations and I thank Chairman Walden (OR-02), Representatives Brian Fitzpatrick (PA-08) and Andy Biggs (AZ-05), and Senator Ron Johnson (PA) for their commitment to getting it ready for floor action. The House will consider Right to Try on Tuesday, March 13th. Following its passage, I look forward to swift Senate action so more Americans facing dire circumstances can find some light in their darkest moments.”
Energy and Commerce Committee Chairman Greg Walden (R-OR) and Health Subcommittee Chairman Michael C. Burgess, M.D. (R-TX) released some details of the bill which you can read here. A few of the key provisions, recently modified to address the concerns of some members from both sides of the aisle, include:
- Establish a robust informed consent to access unapproved drugs
- Specify that any unapproved drug used in the new alternative pathway must have an active application and is not the subject of a clinical hold
- Include a sponsor and manufacturer notification to the FDA after they make an unapproved drug available to an eligible patient
- Guard patients from manufacturers purposefully misbranding or mislabeling drugs
- Provide liability protections for manufacturers, sponsors, physicians, clinical investigators, and hospitals that participate in the existing expanded access program and the new alternative pathway; unless there is reckless or willful misconduct, gross negligence, or an intentional tort
- Obligate sponsors and manufacturers to report adverse events in real time, through notification to the FDA – both within the existing expanded access program and through the new alternative pathway
To be clear, this has absolutely nothing to do with euthanasia, a topic which upsets many conservatives for obvious reasons. There are always experimental drugs in the pipeline which may eventually offer hope for the otherwise terminally ill, but it takes years to get approval to bring them to market. Promising ones which are undergoing trials can be made available to such patients as a course of last resort but approval is required. It’s a touchy subject because you don’t want to build up false hope in the patients or their families. At the same time, pharmaceutical companies don’t want to risk exposure to lawsuits if the drug fails to work or produces a negative, unintended side effect.
But as long as both the manufacturer and the patient are going into the experiment with clear eyes, why wouldn’t you give the patient the right to try, as the bill’s name implies? It could also speed the approval of successful drugs if they wind up being beneficial on real subjects facing those specific diseases. Yes, it’s a program which must be implemented carefully to avoid abuse, but it’s a risk worth taking if the use of such drugs is entirely voluntary on the part of the patient and their family.