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Daily News

June 21, 2021

FDA’s controversial approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) will reverberate for years and have notable impacts on drug development and regulation and raise key questions for insurers, one of the agency’s outside advisers asserts.

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Sens. Dick Durbin (D-IL) and Chuck Grassley (R-IA) said they will introduce legislation to require the disclosure of drug prices in consumer advertisements after they received a government report on the impact of ads on Medicare spending.

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HHS Assistant Secretary for Health Rachel Levine said she wants to prioritize children’s mental health along with other research, treatment and recovery issues, saying the National Institute of Mental Health is in a unique position to study and rectify COVID-19's impact on youth mental health.

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More than 30 Black women’s organizations say FDA should set up an advisory committee focused on racial and gender equity in clinical trials and revise its Institutional Review Board policies to ensure Black women, femmes, girls and gender-expansive people are represented in clinical trials and equitably compensated for their participation.

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FDA is taking steps to address key medical device servicing issues, including by publishing a highly anticipated remanufacturing draft guidance that aims to draw a clear line between medical device servicing and remanufacturing activities and ensure original device manufacturers and third-party device servicers adhere to agency standards for fixing and updating medical devices.

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June 18, 2021

CMS Administrator Chiquita Brooks-LaSure and HHS Secretary Xavier Becerra on Friday stressed a willingness to work with states interested in expanding their Medicaid programs, saying there’s still time for those that want to take advantage of the increased federal matching money in the American Rescue Plan.

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World Trade Organization talks on an approach to waiving some intellectual property obligations in response to the pandemic will speed up to a weekly clip ahead of a July General Council meeting, when members are hoping to report some progress.

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Members of the GOP Doctors Caucus want FDA to prioritize reviewing applications for tests that measure the presence of T-cell immunity to COVID-19, rather than focusing only on reviewing and authorizing applications for rapid diagnostics, point-of-care tests and variant diagnostics.

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Senate Finance Committee members are focusing on how to build the country’s mental health care system as the number of Americans reporting anxiety or depression has nearly quadrupled since the start of the COVID-19 pandemic, yet more than 56% of adults did not receive any mental health treatment in the past year.

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Forty-two states reportedly have applied and been approved for extensions to submit to CMS their initial spending plans and narratives required to access the increased federal Medicaid matching funds for home- and community-based services from the American Rescue Plan, a trend one stakeholder says was expected and isn’t likely to hurt states’ abilities to use the funds.

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Senate Special Committee on Aging Chairman Bob Casey (D-PA) and ranking Republican Tim Scott (R-SC) agreed at a Thursday (June 17) hearing that more thought needs to be given to home- and community-based services policy, but Casey hailed President Joe Biden’s proposal to invest $400 billion in HCBS as the way forward while Scott said a more person-centered, local approach is needed.

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June 17, 2021

While ACA supporters hope the high court’s 7-2 decision to dismiss the constitutional challenge to the Affordable Care Act for lack of standing will end the years-long attack on the law, Justices Samuel Alito and Neil Gorsuch say in their dissent that further legal action is still possible.

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While ACA supporters hope the high court’s 7-2 decision to dismiss the constitutional challenge to the Affordable Care Act for lack of standing will end the years-long attack on the law, Justices Samuel Alito and Neil Gorsuch say in their dissent that further legal action is still possible.

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Rep. Lloyd Doggett (D-TX) introduced a bill Thursday (June 17) that would allow county, city or other local governments to expand Medicaid to cover adults with incomes up to 138% of the federal poverty level in states that have yet to expand coverage to that level.

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Democratic Sen. Joe Manchin (WV) on Thursday (June 17) pressed President Joe Biden to quickly nominate a permanent FDA commissioner who is “more suited to lead” the agency than current acting chief Janet Woodcock and who can be held accountable for and answer questions about agency decisions, including the controversial approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab).

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FDA announced Wednesday (June 16) that it authorized an additional batch of Johnson & Johnson’s COVID-19 vaccine manufactured at Emergent BioSolutions's Baltimore facility, despite repeated health and safety hazards that occurred at the time of production and just days after Canada said it would not use donated J&J vaccines from the facility.

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Democratic lawmakers, beneficiary advocates, insurers, hospitals, and other stakeholders cheered the Supreme Court’s 7-2 decision to throw out the GOP challenge to the Affordable Care Act and called on Congress to now take steps to build upon the law.

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Rep. John Larson (D-CT) is gathering lawmakers to support his request, backed by durable medical equipment suppliers, that CMS keep manual rehab technology out of competitive bidding after the end of the month, when an exemption for those accessories is set to expire.

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Public Citizen has asked HHS Secretary Xavier Becerra to remove or request resignations from acting FDA chief Janet Woodcock and agency officials Patrizia Cavazzoni and Billy Dunn due to their role in the controversial approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab), a decision sparking new calls for a permanent FDA leader and refueling debate over whether Woodcock is right for that role.

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A bipartisan, bicameral group of lawmakers are pushing a revised version of their legislation to spur development of new antibiotics through a subscription-style reimbursement model for antimicrobial drugs.

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