During the 109th General Assembly, state lawmakers approved HB0143/SB0811 … more commonly known as the Tennessee Right to Try Act. The legislation is intended to provide terminally ill patients access to experimental drugs and devices that could have potential life-saving benefits.
“Right to Try was an idea that was created by the Goldwater Institute in Arizona,” said Lindsay Boyd, director of Policy at the Beacon Center, a non-profit, nonpartisan organization focused on public policy to eliminate government barriers perceived to interfere with individual rights. “So the credit goes to the Goldwater Institute for coming up with this really patient-driven reform that curbs the emphasis of protecting the industry and puts the emphasis back on protecting the patient.”
Boyd first became aware of the initiative a couple of years ago before it had been introduced in any state houses. In 2014, five states passed Right to Try laws.
As of late June, Tennessee and 21 other states now have some version of Right to Try laws, another 18 states have introduced bills, and legislation also has been introduced nationally.
The law affords protections for physicians, pharma companies and medical manufacturers while loosening the regulations on terminally ill patients. “We believe this strikes the perfect balance,” Boyd said.
Insurers can cover the cost of treatment but don’t have to do so. Pharmaceutical companies can provide the experimental drugs for free or at cost (although they cannot make a profit) but don’t have to do so. The manufacturers also retain right of refusal if they believe a patient isn’t an appropriate candidate.
“We wanted to make sure this was a ‘mandate light’ piece of legislation,” Boyd explained. “It’s a free will bill. It’s designed to open the access and open the conversation between the pharmaceutical company, patient and doctor.” She added, the law extends to medical devices, as well.
Just as there are potential benefits to patients, Boyd said there are also benefits to manufacturers. “As we know, the approval process takes on average 10 years … and now it is jumping up toward 12 years,” she said of moving through the Food and Drug Administration cycle.
Boyd said an ancillary hope of these laws is to open a dialogue about reforming the FDA process. “We’re sending patients to Europe to access drugs produced here. It’s really a backward process,” she said.
In the meantime, by allowing patients who have exhausted other options early access to treatments that have already passed the Phase I clinical trial stage, manufacturers might be able to show efficacy more quickly and ultimately help expedite FDA authorization.
However, Boyd noted, “If a drug drops out of that process at any point before it gets the FDA stamp of approval, it is no longer eligible to be a Right to Try drug.”
To participate, patients must assume responsibility if any costs are involved and must sign a consent form waiving liability for their physician, the manufacturer, and their insurance company.
Boyd said the law really represents a win/win. “That’s why we think this bill is really revolutionary and can be supported by everyone involved.”
She concluded, “Ideally, we hope the law might save a life. That’s our ultimate goal. We don’t want to promise anyone false hope … but we do want to give patients hope where there was none before. We think it’s the least we can do for these patients.”
