Weighing the ‘Right to Try’ law

Jordan McLinn wants to be a firefighter when he grows up. But before he has a chance to save anyone’s life, he’s been in a fight for his own.

Now 6, Jordan became the charming, high-profile face of Indiana’s “Right to Try” legislation that sailed through the General Assembly this year and was signed into law by Gov. Mike Pence. Indiana joined two dozen other states that have passed laws granting terminally ill patients access to unapproved medications when there are no other treatment options.

Jordan has a form of muscular dystrophy for which there are experimental treatments in the early phases of clinical trials. His mother, Laura McLinn, said Right to Try might open the door for Jordan to gain access to promising medicine through participation in clinical trials or under the law’s prescriptions.

“For the first time in the history of muscular dystrophy, there are some drugs coming up through the pipeline that could actually slow the progression,” she said. The treatments for Jordan’s strain of MD offer unprecedented hope: McLinn said some of the treatments in clinical trials may allow patients who typically only live into their 20s to extend their lives into their 60s.

Since his appearances at the Statehouse this year, Jordan has become a prominent face in the national Right to Try movement, championed by the influential Goldwater Institute. In just a little more than two years, nearly half the states have adopted measures like Indiana’s House Enrolled Act 1065, and bills have been introduced in most other statehouses.

But attorneys who practice in this area of law say Right to Try, while well-intended, is no panacea. Nevertheless, the effort appears to be having tangible results in improving access to trial drugs and expediting the Food and Drug Administration’s approval process.

Rep. Wes Culver, R-Goshen, said he introduced the legislation in response to learning that medical aid workers returning from Africa and testing positive for Ebola had few treatment options. Culver said he’d want experimental drugs available for use in case of an outbreak.

“Another reason why I felt like it could be a good thing is it’s a stepping-stone to pushing federal law,” Culver said. “So many states passed this that it was a warning shot over the bow” toward the FDA.

The state’s Right to Try statute, I.C. § 16-18-2-193.5, builds in immunity from liability for providers, and Culver stressed that the law requires mutual consent of the patient, doctor and provider. The law says in those cases, people with terminal illnesses may access medications that have cleared Phase 1 clinical trials but still face multiple rounds of testing that can take years.

Overmyer

Culver said the pharmaceutical industry was neutral on the legislation, and Bingham Greenebaum Doll LLP partner Jeremy Overmyer said that’s likely because the law doesn’t compel companies to provide experimental drugs, nor does it impose additional obligations on them.

“The most significant point to note is that while the Indiana Right to Try law may adequately protect a provider from liability under state law, federal law may still impose a liability risk. The law helps to clarify the specific protection afforded to providers under state law actions, but it does not clarify risks under federal law. The greatest risks here are in the uncertainties,” said Overmyer, an associate whose practice focuses on health care and regulation.

According to the FDA, Phase 1 trials typically involve 20 to 100 test subjects with the disease or condition the medication is designed to treat. This phase usually takes several months, and about 70 percent of Phase 1 trial drugs move on for further trials under the approval scheme.

 Judge-Prein

Amy Judge-Prein is an attorney at Faegre Baker Daniels LLP who counsels companies and research institutions in the FDA-regulated space. She also teaches food and drug law at Indiana University Robert H. McKinney School of Law.

“If you’re in this area as a health-care provider or a life-sciences company, you need to know and be aware of expanded access, both through FDA rules and these state laws,” she said.

Judge-Prein said the FDA has responded to the increased interest in Right to Try by streamlining its processes through which patients can access trial drugs via federal compassionate-use exceptions and expanded access, for instance.

“You get this kind of groundswell of patients saying, ‘how can our needs be built into current laws?’” she said. “… These things may ultimately lead to more substantive changes.”

Overmyer said there are arguments taking place for and against Right to Try laws in the health care industry. “Proponents of the law argue that these laws allow access to experimental drugs for terminally ill patients who would otherwise not have the opportunity, and the law gives more control to patients in their end-of-life decisions. Opponents argue that the law may not benefit the terminally ill and could jeopardize the viability and integrity of clinical trials.”

Judge-Prein said pharmaceutical manufacturers and other drug developers face a dilemma as states pass Right-to-Try laws because, ultimately, they must comply with the Federal Food, Drug and Cosmetic Act.

“When a drug is not approved under our federal laws and regulations, then it would be against the law in the strictest sense to provide that drug to a patient for use,” she said. “The only way a manufacturer can supply an unapproved drug is within a recognized exception, such as within a valid clinical trial or through one of the FDA’s expanded access programs.”

Overmyer noted the FDA has approved 99.5 percent of compassionate-use requests since 2010, and he and Judge-Prein agreed the agency has made the drug approval process more accessible and timely.

“There are lots of things in this area of business where states will one-off try to create a law or obligation,” Judge-Prein said. “Most often if that leads to some change at the federal level, that has the most effect. And from a business standpoint, it is easier to meet one federal standard than to have to learn and apply each different state law.”

Despite the groundswell of support for Right to Try laws nationwide, Judge-Prein said an important consideration is consumers’ public-policy interest in a regulatory system that ensures pharmaceuticals are safe and effective.

State Right-to-Try laws also may be subject to future federal preemption challenges under the Supremacy Clause.

“Because of the uncertainty of conflict with federal law, it seems likely that counsel will continue to advise providers to go through the FDA process to obtain experimental drugs for qualified patients,” Overmyer said.

“Anything having to do with drug research and critically ill patients, there are rarely simple answers to very complex problems,” Judge-Prein said.

McLinn said Jordan is doing fine now, but his doctor believes the earlier he can get treatments that may prolong his life, the better. After Jordan turns 7, she said, it’s likely the disease will begin taking a toll. “Once you start deteriorating, you can’t get back what you’ve lost, basically,” she said.

She said she and Jordan are proud of their part in raising awareness and championing access to potentially life-saving cures.

“I hope it benefits Jordan, but if not, I hope it benefits someone,” McLinn said. “We know something’s going to happen for Jordan. If it does, in fact, help someone and prolong their life, I think that would be awesome for Jordan to look back on.”•