August 4, 2017

Senate approves 'right-to-try,' FDA user fees, Jessie's Law

Daily Briefing

    The Senate on Thursday passed two bipartisan bills that affect FDA policies. The Senate also voted by unanimous consent to approve a bill (SB 581) that would require HHS to develop and share best practices for displaying whether a patient has had an opioid use disorder in his or her medical records.

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    Senate advances 'right-to-try' bill                                               

    The Senate in a unanimous vote advanced so-called "right-to-try" legislation (S 204), which would bar FDA from interfering with state laws that allow patients to access experimental drugs that have not yet been approved by the agency. According to Morning Consult, 37 states have such laws.

    The bill also would establish federal rules intended to help terminally ill patients in all 50 states access drugs that have not yet received FDA approval, but that have gone through preliminary testing on humans and are being evaluated through research overseen by the agency. In addition, the bill would protect drugmakers and physicians who help patients get such drugs from potential legal repercussions.

    Sen. Ron Johnson (R-Wis.), who introduced the measure, said it would give patients in need new hope and medical alternatives.

    Sen. Michael Bennet (D-Colo.) said, "Over the last 20 years, FDA has approved roughly 190 new cancer treatments for adults but just three new treatments for children. FDA saw that gap, and they have asked us to close it."

    However, opponents of the legislation, including Public Citizen, said it would undermine the FDA's ability to oversee experimental procedures.

    Alison Bateman-House, an assistant professor of medical ethics at the New York University Langone Medical Center, said removing federal oversight could increase risk for fraud or abuse. Bateman-House said, "This area is already replete with confusion, and we don't need any more confusion," adding, "I think patients are going to end up losing."

    The right-to-try bill now goes to the House. According to Morning Consult, Reps. Andy Biggs (R-Ariz.) and Brian Fitzpatrick (R-Pa.) have introduced a companion bill in the House and, according to the New York Times, more than three dozen House lawmakers have endorsed such legislation.

    House Majority Leader Kevin McCarthy's (R-Calif.) office was not available to comment on when the House might take up the bill, Morning Consult reports.

    Senate passes bill to reauthorize FDA user fees

    After the Senate advanced the right-to-try bill, the chamber then voted 94-1 to approve legislation (HR 2430) that would reauthorize FDA's user fee agreements.

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    Sen. Bernie Sanders (I-Vt.) was the only senator to vote against the bill, which the House passed last month. Sanders spokesperson Josh Miller-Lewis said the senator voted against the measure because it "does nothing to lower drug prices and is a giveaway to the pharmaceutical industry."

    The bill would reauthorize FDA's four user-fee agreements, which are set to expire at the end of September, that give the agency the authority to collect fees from medical device and drug companies to help pay for product reviews. The fees account for a majority of FDA's budget for both brand and generic drug reviews.

    The measure would increase the user fees paid by medical device and drug companies by $400 million in fiscal year (FY) 2018 to increase staffing at the agency and accelerate product approvals. User fees would increase incrementally each year through FY 2022.

    The bill also would:

    • Allow hearing aids to be sold over the counter;
    • Create a pilot project to evaluate the post-market safety of medical devices;
    • Ease requirements for medical imaging devices;
    • Encourage drug and device developers to develop and test new pediatric oncology treatments; and
    • Offer a six-month exclusive rights period for first-time generics entering a limited market in an effort to increase generic drug competition.

    In addition, the bill would change the reporting process for medical device malfunctions. Currently, medical device makers submit malfunction reports for their products within 30 days of the problem surfacing. Under the bill, medical device makers would need to submit only one report every three months detailing known problems with their products.

    The bill now heads to President Trump. According to Regulatory Focus, a Trump spokesperson said Trump "will sign this bill, but we look forward to working with Congress to address further negotiations."

    Senate passes 'Jessie's Law'

    The Senate on Thursday also approved by unanimous consent SB 581, which would require HHS to develop and share best practices for displaying whether a patient has had an opioid use disorder in his or her medical records, Medscape reports.

    Sens. Joe Manchin (D-W. Va.) and Shelley Moore Capito (R- W. Va.) introduced the so-called "Jessie's Law" bill in March. Under the bill, the HHS secretary would be tasked with working with industry stakeholders to develop standards that hospitals and physicians could use to "prominently" display a patient's history of opioid use disorders in their medical record. However, the patient first would need to give consent for such information to be shared.

    The measure now heads to the House, where by. Reps. Debbie Dingell (D-Mich.) and Tim Walberg (R-Mich.) have introduced a companion proposal (HR 1554). The House has yet to take up HR 1554 (Reid, Morning Consult, 8/3; Karlin-Smith, Politico, 8/3; Pear/Kaplan, New York Times, 8/3;  Bloomberg/Indianapolis Business Journal, 8/3; Edney, Bloomberg, 8/3; Brennan, Regulatory Focus, 8/3; Weixel, The Hill, 8/3; Scott, Vox, 8/3; AHA News, 8/3; Ault, Medscape, 8/3).

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