Yesterday, May 30, 2018, United States President Donald Trump signed the somewhat controversial “Right to Try” Act, which was passed in Congress largely along party lines. As the legislation winded its way through Congress, the White House made known its desire to see the legislation passing, with President Trump even making mention of it in his State of the Union speech. It’s likely that Vice President Mike Pence – a longtime supporter of the concept – was a fierce advocate of the bill and he was able to secure President Trump’s support and presidential soapbox.
The bill will allow the provision of unapproved, investigational drugs to terminally ill patients that have exhausted approved treatment options if they are unable to participate in clinical trials involving the innovative treatments. Only drugs that are in active clinical trials and have cleared initial preliminary testing may be considered. The legislation also requires the manufacturers of eligible investigational drugs to report annually to the FDA on usage under the law, a summary of which would be published online by the agency. The bill does not obligate drug makers to provide the treatments, nor does it prevent them from charging patients for associated costs if treatment is provided.
This bill has a storied past, including changes in support from bipartisan to somewhat partisan. In August 2017, the Senate passed ‘right to try’ legislation by unanimous consent, but the House took up their own version of the measure after Energy and Commerce Committee Chairman Greg Walden expressed concerns with the Senate bill. However, once House Democrats began to speak out about concerns about patient safety, Senate Democrats followed suit, and the path forward in the upper chamber became increasingly tenuous.
When Senate Minority Leader Charles Schumer objected to a request to bring the House bill up by unanimous consent (as the prior bill had been passed in the Senate), ‘right to try’ advocates saw a House vote on the Senate-passed version as their best path forward.
Key provisions of the right to try bill include:
- establishing a robust informed consent to access unapproved drugs;
- specifying 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;
- guarding patients from manufacturers purposefully misbranding or mislabeling drugs;
- providing 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;
- obligating 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; and
- providing certainty to manufacturers regarding how the FDA will use patient outcomes when evaluating new drug applications.
Prior to the signing and enactment of this legislation, right-to-try laws existed in 38 states: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia, Washington and Wyoming. However, the enactment of this federal bill will introduce legislation across state lines.