New ‘Right to Try Act’ has lots of legal ins and outs

On May 30, President Trump signed into law the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017,” more easily known as the “Right to Try Act.”

The Right to Try Act provides that terminally ill patients have a right to try drugs not yet approved by the U.S. Food and Drug Administration, in a last-ditch effort to address their health problem. This seems straightforward, and appealing. If a patient is dying, anyway, why not let him or her try any available alternative?

The law applies to an “eligible patient” who wants to use an “eligible investigational drug.” The eligible patient is defined as one whose life is in jeopardy, who has exhausted approved treatments and is not participating in a clinical trial, whose participation has been certified by a treating physician, and who has provided an informed consent. The “eligible investigational drug” is one that has completed its Phase 1 clinical trial (testing for toxicity), is in ongoing trials, and whose production is continuing or has not been put on hold.

There are additional implementing provisions that provide mostly clarity but have also triggered some concerns. First, the results of this usage cannot be used to “delay or adversely affect the review or approval” of the drug, unless the secretary of Health and Human Services decides it is critical to safety, or the sponsor requests such. Reports of the performance of the drug must be filed with the secretary and made available on the web. The risk of adverse events cannot generally be used against the manufacturer in its ongoing effort to get FDA approval.

If, on the other hand, the drug has a direct and ascertainable positive impact, the law does not preclude the use of that information. Interestingly, the secretary of HHS (not the FDA) is the designated party to decide if the public interest demands that negative information be disclosed. Many saw this as a swipe at the FDA.

The law also protects involved parties from liability. Operating under these provisions, the manufacturer cannot be held liable for the results, period. In the case of the prescriber, dispenser or “other individual entity,” there is to be no liability unless there is recklessness, willful misconduct, gross negligence or an intentional tort “under any applicable state law.”

While these are very high burdens of proof, they leave open a window of risk to the doctor, the pharmacist and any “other individual entity.” That last term is an unclear reference, and the application of “applicable state law” also leaves room for argument as to which state laws should be applied. Hopefully, these ambiguities will not take on a life of their own, in these narrow, humanitarian circumstances.

While patient advocates have hailed the new law, the Right to Try Act has also been the subject of significant criticism. First, the fact that manufacturers can provide the investigational drug does not mean they will provide it. There is no requirement that pharmaceutical or biotech companies provide these compounds and, in fact, the law states there shall be no liability for declining to provide the drug. Manufacturers might not have enough of the compound on hand to fuel the dosing and might conclude they are not in the business of managing these types of early experiments.

Similarly, doctors and dispensers are concerned that they have a liability exposure, however small. It remains to be seen whether malpractice insurers will extend coverage to this type of risk.

But at the end of the day, dying patients do, indeed, have a right to try what might be their last hope, if the investigational drug meets the defined criteria. Indiana was an early, state-level adopter of this type of legislation, and the Indiana congressional delegation was bipartisan in its advocacy of its passage.

Jordan McLinn, one of the namesakes of the bill, is an 8-year-old Hoosier with muscular dystrophy. If you didn’t see him charm Trump at the signing ceremony, it’s worth searching for on the web. It was, indeed, a heart-rending moment.•

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R. Matthew Neff is of counsel at Bingham Greenebaum Doll LLP, and a senior adviser to Evolution Capital Partners.