Author

Rachel Sachs

  • FDA

    New Discussion Draft of 21st Century Cures Act Released (Again)

    By Rachel Sachs Earlier today, the House Energy and Commerce Committee released the most recent draft of the 21st Century Cures Act, in time for it to be marked up by the Health Subcommittee tomorrow.…

    New Discussion Draft of 21st Century Cures Act Released (Again)

  • FDA

    New Discussion Draft of 21st Century Cures Act Released

    By Rachel Sachs Yesterday, a new discussion draft of the 21st Century Cures Act was released, just in time for today’s hearing on the draft before the House Energy and Commerce Committee.  At just 200…

    New Discussion Draft of 21st Century Cures Act Released

  • Biotechnology

    The Complex Effects Of The FDA’s Proposal To Regulate Laboratory-Developed Tests

    This new post by Rachel Sachs appears on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015. Last fall,…

    The Complex Effects Of The FDA’s Proposal To Regulate Laboratory-Developed Tests

  • Health Insurance & Coverage

    Academic Fellow Rachel Sachs in the SCOTUSblog, on King v. Burwell

    Academic Fellow Rachel Sachs was quoted today in the SCOTUSblog: Wednesday’s oral arguments in King v. Burwell, the challenge to the availability of tax subsidies for individuals who purchase their health insurance on a marketplace created…

    Academic Fellow Rachel Sachs in the SCOTUSblog, on King v. Burwell

  • Health Care Reform

    King v. Burwell: Appreciating the Stakes of the Case

    By Rachel Sachs Yesterday, the Supreme Court heard oral arguments in King v. Burwell, and the Justices seemed split on the central issue of whether the Affordable Care Act (ACA) permits health insurance subsidies to…

    King v. Burwell: Appreciating the Stakes of the Case

  • FDA

    The Medical Innovation Act: Addressing the Shrinking NIH Budget

    By Rachel Sachs Senator Elizabeth Warren (D-MA) recently introduced a new bill, the Medical Innovation Act, which would require pharmaceutical companies who settle with the government after committing certain illegal activities to reinvest additional money…

    The Medical Innovation Act: Addressing the Shrinking NIH Budget

  • FDA

    Highlights from the 21st Century Cures Act

    By Rachel Sachs At the end of January, the House Energy & Commerce Committee released a discussion draft of the 21st Century Cures Act.  This document marks the beginning of the legislative phase of the…

    Highlights from the 21st Century Cures Act

  • Biotechnology

    FDA Holds Public Workshop on Regulatory Oversight of Laboratory-Developed Tests (Part II)

    By Rachel Sachs The FDA’s public workshop on their draft guidance framework for the regulation of laboratory-developed tests (LDTs) continued yesterday, featuring sessions on three additional issues: 1) notification and adverse event reporting, 2) public…

    FDA Holds Public Workshop on Regulatory Oversight of Laboratory-Developed Tests (Part II)

  • Biotechnology

    FDA Holds Public Workshop on Regulatory Oversight of Laboratory-Developed Tests (Part I)

    By Rachel Sachs Over the past several months, I’ve been blogging (here, here, and here) about the FDA’s recent forays into regulating laboratory-developed tests (LDTs).  Since the release of the draft guidance framework in October,…

    FDA Holds Public Workshop on Regulatory Oversight of Laboratory-Developed Tests (Part I)