Commercial risk will be a critical catalyst of progress – it’s complicated, but is it possible? We think so.


May 23, 2018

Congress sends controversial 'right-to-try' bill to Trump

Daily Briefing

    The House on Tuesday voted 250-169 to approve a so-called "right-to-try" bill (S 204) that would establish criteria to expand terminally ill patients' access to experimental drugs.

    Just updated: Your cheat sheets for understanding health care's legal landscape

    The House previously failed to pass its own version of a right-to-try measure amid pushback from Democratic lawmakers who had expressed concerns about patient safety. President Trump earlier this year said enacting right-to-try legislation was one of his top priorities and, according to Politico, Trump in recent weeks pressed lawmakers to pass a right-to-try bill.

    As a result, leaders in the House decided to take up S 204, which the Senate approved last month. The House approved that measure largely along party lines, with 228 Republicans and 22 Democrats voting in favor of the bill and 169 Democrats voting against it. The bill now heads to Trump, who is expected to sign it.

    Bill details

    According to the Wall Street Journal, about 40 states currently have laws that allow patients to access experimental drugs that have not yet been approved by the agency. The bill would establish federal rules to expand such access to patients in all 50 states who have "a life-threatening disease or condition" and have "exhausted approved treatment options and [are] unable to participate in a clinical trial."

    The bill would allow such patients to request experimental treatments directly from drugmakers. Patients would be required to provide informed consent in writing before obtaining the treatments.

    Drugmakers would not be required to provide patients with the requested treatments, but those that do would have to provide the federal government with an annual summary of the drugs' uses, including "any known serious adverse events" that occur.

    In addition, the bill would protect drugmakers and physicians who help patients get such drugs from potential legal repercussions. According to the New York Times, health care providers would be protected under the bill as long as they did not engage in "reckless or willful misconduct" or "gross negligence," or harm a patient intentionally.


    Supporters said the legislation would give patients with terminal illnesses hope.

    Rep. Vern Buchanan (R-Fla.) said, "A patient with a life-threatening disease who wants to take a chance on a promising treatment should be allowed to do so," adding, "They may not have the time to wait for final FDA approval, which can take years."

    But some Democratic lawmakers continued to raise patient safety concerns.

    Rep. Frank Pallone (D-N.J.) said, "This will provide fly-by-night physicians and clinics the opportunity to peddle false hope and ineffective drugs to desperate patients." He added that, without FDA's oversight, "there is no guarantee that what somebody gets as a form of treatment is going to be meaningful and not be harmful," and "there is no way for the patient to know whether the doctor is unscrupulous or whether the manufacturer is unscrupulous."

    According to the Journal, FDA Commissioner Scott Gottlieb last week said he was "comfortable" with the measure and would address any concerns the agency has while implementing the bill. Gottlieb on Tuesday tweeted, "When the House passes [right-to-try] legislation I stand ready to implement it in a way that achieves Congress’ intent to promote access and protect patients; and build on [FDA's] longstanding commitment to these important goals" (Armour, Wall Street Journal, 5/22; Haberkorn, Politico, 5/22; Pear, New York Times, 5/22; Roubein, The Hill, 5/22; Kodjak, "Shots," NPR, 5/22).

    Just updated: Your cheat sheets for understanding health care's legal landscape


    To help you keep up with the ever-changing regulatory environment, we recently updated our cheat sheets on some of the most important—and complicated—legal landmarks to include a brand new one-pager on the new tax law.

    Check out the cheat sheets now for everything you need to know about MACRA, the Affordable Care Act, antitrust laws, fraud and abuse prevention measures, HIPAA, and the two-midnight rule.

    Get the Cheat Sheets

    Have a Question?


    Ask our experts a question on any topic in health care by visiting our member portal, AskAdvisory.