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    CBO: Proposed Medicare pricing plan could curb drug development

    A new drug development model released by the Congressional Budget Office (CBO) estimates a Medicare drug pricing bill like the one proposed by Democrats in the US House of Representatives could result in between 21 and 59 fewer drugs brought to market over the next three decades.   The Elijah E. Cummings Lower Drug Costs Now Act ( H.R. 3 ), introduced in the 116th Congress during the 2019-2020 legislative session, would require the Secretary of Health and Human Servi...
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    HHS proposes updates to patient labeling, BA/BE study regulation

    The US Department of Health and Human Services (HHS) has released its semiannual inventory of proposed rulemaking actions, with a relatively brief to-do list for drug and medical device regulators.   For the US Food and Drug Administration (FDA), actions sitting at the proposed rule stage include an amendment to 21 CFR 320 to clarify FDA’s expectations for the conduct of analytical and clinical pharmacology as well as bioavailability and bioequivalence studies to suppo...
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    HHS hits pause on Trump era SUNSET rule

    The US Department of Health and Human Services (HHS) is postponing the implementation of a controversial Trump era rule that would have required the department to review thousands of its regulations while the rule undergoes judicial review.   The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) was first proposed in November 2020 and finalized on 19 January 2021, one day before President Joe Biden’s inauguration. At its core, the rule would sunset m...
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    HHS, FDA dispute spills out onto Twitter

    In the final months and weeks of the Trump administration, the Department of Health and Human Services (HHS) has advanced several policies to consolidate its authority over the US Food and Drug Administration’s (FDA). Today, with just one day left in the Trump administration, the latest dispute between HHS and its subagency spilled into the public. Following media reports last week that FDA Commissioner Stephen Hahn refused to sign a memorandum of understanding (Mo...
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    HHS pushes through last-minute policies impacting FDA

    With just days remaining before the transition to a new administration, the Department of Health and Human Services (HHS) is pushing through policies that could impact the US Food and Drug Administration’s (FDA) regulatory oversight.   Last week, HHS announced it had finalized a rule that would cause its regulations to expire if they are not reviewed every 10 years, with some exceptions provided for medical device-specific regulations, food standards and over-the-cou...
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    HHS moves to end FDA’s unapproved drugs initiative

    Following an announcement by outgoing President Donald Trump on Friday, the Department of Health and Human Services (HHS) is moving to end the Food and Drug Administration’s (FDA) unapproved drugs initiative, which the agency claims has led to increased drug prices for some older drugs. FDA’s unapproved drugs initiative can be traced back more than a decade to the agency’s 2006 compliance policy guide (CPG) on marketed drugs without approved new drug applications (NDAs...
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    HHS seeks drug importation waiver applicants

    The US Department of Health and Human Services (HHS) has issued a request for proposals (RFP) from individuals who wish to seek waivers permitting them to import prescription drugs from certain countries.   The RFP, issued 24 September 2020, provides a pathway for individuals who have waivers to import some FDA-approved drugs through authorized state-licensed pharmacies. Countries considered an “acceptable foreign source” by HHS for the purposes of the waiver include A...
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    HHS, to address insulin price crisis, issues RFP for reimportation

    The US Department of Health and Human Services (HHS) has issued a request for proposals for reimportation of insulin produced in the United States and exported for sale abroad.   The measure, said HHS, is meant to address the fact that “The rising price of insulin, and corresponding rationing of insulin, constitutes an emergency” within the US. The agency noted that insulin prices rose nearly six-fold between 2002 and 2016. One commonly prescribed insulin, said HHS, ha...
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    HHS opens pathway to importing Canadian drugs

    The US Department of Health and Human Services (HHS) has issued a final rule that clears a path for importation of some Canadian drugs into the US. The measure follows a 24 July 2020 executive order issued by President Donald Trump that directed the HHS secretary to take action to expand access to lower-cost imported drugs. In a 24 September press release, the US Food and Drug Administration (FDA) said that the final rule would help affordability of drugs for US patient...
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    GAO highlights continued PPE shortages in COVID-19 report

    The United States continues to struggle with shortages of personal protective equipment (PPE) and testing supplies due to high global demand and the fact that most supplies are made outside of the US, according to new findings from the US Government Accountability Office (GAO).   In a wide-ranging report on the US federal response to COVID-19, the GAO issued 16 new recommendations for federal agencies spanning the medical supply chain, vaccines and therapeutics, COVI...
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    Pharmacists can give COVID-19 vaccines, says HHS

    The US Department of Health and Human Services has authorized all state-licensed pharmacists and pharmacy interns who have completed required training to administer vaccines for COVID-19 when they become available.   The new guidance , dated 3 September 2020, supersedes any state or local laws that “prohibit or effectively prohibits” pharmacists and interns who would otherwise be able to perform vaccination under the new HHS directive.   However, the guidance sets...
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    Device Industry Backs Proposed Changes to Anti-Kickback Statute, Stark Law

    Device industry group AdvaMed on Wednesday pledged its support for proposed the Department of Health and Human Services (HHS) changes to modernize and clarify the regulations that interpret the physician self-referral law, known as the “Stark Law,” and the federal anti-kickback statute. In addition to addressing concerns that these laws unnecessarily limit the ways in which health care providers can coordinate care for patients, the proposed rule from HHS’ Office of th...