Two months ago today, in a rare act of actually getting something done, the Senate passed a controversial but important measure commonly known as national Right To Try legislation. It’s a proposal which would make it easier for terminally ill patients who are near the end of life to gain access to new medications which have not yet been fully approved by the FDA. It would also shield the drug companies, doctors and hospitals who arranged to fulfill the request from certain legal liabilities. (New York Times)
Under current law, drug companies can already provide access to patients outside of clinical trials under a program known as expanded access or compassionate use. The F.D.A. says it approves about 99 percent of compassionate use requests. But companies sometimes refuse, fearing that the results could be used against them by the F.D.A.
In some cases, drug makers fear they could be sued by patients who say they have been injured by unapproved drug products.
The bill would establish national standards and rules to help channel drugs still under development to terminally ill patients. It would also shield pharmaceutical companies and doctors from some of the legal risks of providing drugs that have not been approved by the agency.
Freedom Partners has more information on the bill and why it’s important to patients and their families.
Each year, thousands of terminally ill patients suffer while awaiting final approval for drugs, therapies, and other medical technologies. While the U.S. Food and Drug Administration carries out its three-phase approval process – which can take years and cost billions of dollars – many patients simply want the chance to try treatments that have already demonstrated a level of safety.
To date, 37 states have already signed their own Right to Try legislation into law. However, national legislation would ensure that terminally ill patients in all 50 states, together with their doctors and pharmaceutical manufacturers, are allowed to administer investigational treatments where no alternative exists.
When it comes to end of life medical care and decisions, I understand that I go to bat for some ideas which are not always popular among many of my conservative friends. I happen to support voluntary death with dignity options for the terminally ill (or assisted suicide if you prefer), realizing that many of you see it very differently. We can agree to disagree.
But this is actually a separate matter and I would hope that there wouldn’t be as much opposition. If both the patient and their doctor agree that time is running out and the patient has no other options beyond prayer, but there is a drug which is part way through FDA approval and might be able to save them, why not allow the patient to take the chance? Even in the case of patients who are no longer responsive and are unable to give consent, if arrangement with their caretakers and/or family were made in advance, agreeing to “leave no stone unturned” in a search for help, perhaps they could authorize it as well.
We’re talking about patients who are literally out of chances and are going to pass on soon anyway. If they want to risk a few weeks of life (in a worst case scenario) in exchange for a cure, or at least a long term extension of life and relief from their ailment, would you really deny them that chance? And if so, on what grounds? If you feel that the decision is up to God then the doctors shouldn’t have been treating them in the first place. This is simply cutting out some of the red tape.
And if it works, it not only helps that one patient but provides vital data for the FDA to consider when deciding on wider approval. I honestly don’t see how this is controversial. And the House should get in gear and pass this promptly and send it to the President.