March 14, 2018

'Right-to-try' bill fails in the House

Daily Briefing

    The House on Tuesday failed to approve a so-called "right-to-try" bill (HR 5247) that would have established criteria to expand terminally ill patients' access to experimental drugs that have not been approved by FDA.

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    The vote came after President Trump in his recent State of the Union address urged Congress to pass right-to-try legislation.

    The House sought to advance the bill under a suspension of the chamber's rules, which requires a bill to receive support from two-thirds of the voting House members, instead of a simple majority, to advance. The House voted 259-140 to advance the measure, falling short of the two-thirds majority required. Most Republicans voted in favor of the measure and most Democrats voted against it.

    Bill details

    Republican leaders on the House Energy and Commerce Committee had introduced the bill on Saturday. They described the measure as an updated version of the Senate's "right-to-try" proposal, which would establish federal rules intended to help terminally ill patients in all 50 states access drugs have gone through preliminary testing on humans and are being evaluated through research overseen by FDA, but have not been approved by the agency. According to the Washington Post's "To Your Health," the House's version of the bill retains some aspects of the Senate proposal, but also contains certain changes intended to ease concerns raised by FDA Commissioner Scott Gottlieb and critics.

    Specifically, the House bill narrows who would be eligible to access experimental drugs from patients with life-threatening diseases or conditions, as proposed in the Senate bill, to terminally ill patients who are likely to die in a "matter of months" or who have conditions with "significant irreversible morbidity that is likely to lead to severely premature death."

    In addition, GOP committee aides said the House's bill includes provisions for a more robust informed consent process when compared with the Senate's bill. For instance, the House bill would require physicians to immediately notify FDA of any adverse events associated with experimental drugs. The House bill also includes broader liability protections for manufacturers and others involved in expanding patients' access to experimental drugs.

    Both the House and Senate bills would allow FDA to consider adverse event reports associated with the experimental drugs as a part of the agency's drug-approval review process if the reports involved complications "critical to determining the safety of the drug," according to "To Your Health."

    Next steps

    House Majority Leader Kevin McCarthy (R-Calif) said, "The House will not let this be the end" and "will try again [to] pass legislation and bring hope to those whose only desire is the right to try to live."

    According to Politico, a GOP aide said House Republicans likely will attempt to attach the measure to a larger legislative package or bring up the Senate's "right-to-try" bill for a vote. According to Axios' "Vitals," a senior GOP aide also said the House could consider its right-to-try measure under regular order, which could allow the bill to advance with a simple majority vote.

    Reaction

    House Energy and Commerce Committee Chair Greg Walden (R-Ore.) and Rep. Michael Burgess (R-Texas), who chairs the Committee's subcommittee on health, in a joint statement said they were "incredibly disappointed" that the bill did not advance, adding, "For months we sought to strike the right balance by allowing patients greater access to these unapproved treatments and therapies while also ensuring proper patient protections. This bill does just that."

    Rep. Frank Pallone (D-N.J.), the ranking member on the committee, in a statement said the bill's failure to advance "protected patients and supported FDA's continued role in approving experimental treatments that may help save a patient's life."

    Michael Carome, director of Public Citizen's Health Research Group, in a statement  praised House lawmakers "who voted against" the measure, saying the bill "would have created a dangerous, uncharted pathway for accessing experimental medications that have not been shown to be safe or effective" (Roubein, The Hill, 3/13; McGinley, "To Your Health," Washington Post, 3/13; Ross Johnson, Modern Healthcare, 3/13; Baum, MedCity News, 3/13; Karlin-Smith, Politico, 3/13; Baker, "Vitals," Axios, 3/14; House Energy and Commerce Committee release, 3/13).

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