Author

rachelsachs

Robert I. Field is professor of law at the Kline School of Law and professor of health management and policy at the Dornsife School of Public Health at Drexel University. He is also a senior fellow of the Leonard Davis Institute of Health Economics at the University of Pennsylvania.
  • Health Law Policy

    Pharmaceutical Transparency Bills: Targeting Disclosures Purposefully

    By Rachel Sachs On Monday, the Massachusetts Joint Committee on Health Care Financing held a hearing on Senate bill 1048, which would require pharmaceutical companies to report to the state a range of information on…

    Pharmaceutical Transparency Bills: Targeting Disclosures Purposefully

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    rachelsachs

  • Events

    Medicaid Expansion Through Section 1115 Waivers: Evaluating The Tradeoffs

    This new post by Rachel Sachs appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016. Nearly six years…

    Medicaid Expansion Through Section 1115 Waivers: Evaluating The Tradeoffs

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    rachelsachs

  • FDA

    FDA Announces Draft Guidance That Would Limit Enforcement Discretion for FMT

    By Rachel Sachs Yesterday, the FDA announced a new draft guidance regarding its exercise of its enforcement discretion around the investigational new drug (IND) requirements as they apply to fecal microbiota transplantation, or FMT.  For…

    FDA Announces Draft Guidance That Would Limit Enforcement Discretion for FMT

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    rachelsachs

  • FDA

    Evolving Industry Structures in Biosimilar Development

    By Rachel Sachs Yesterday, I had the privilege to moderate a fantastic event here at the Petrie-Flom Center on Assessing the Viability of FDA’s Biosimilars Pathway.  Bringing together expert panelists from legal practice (Donald R.…

    Evolving Industry Structures in Biosimilar Development

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    rachelsachs

  • FDA

    March-In Rights Alone Won’t Solve Our Drug Pricing Problems

    By Rachel Sachs On Monday, a group of over 50 members of Congress sent a letter urging the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) to use a…

    March-In Rights Alone Won’t Solve Our Drug Pricing Problems

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    rachelsachs

  • FDA

    Senator Cruz’s RESULT Act Unlikely to Achieve Results

    By Rachel Sachs On Thursday, Senators Ted Cruz and Mike Lee introduced the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act (text), which would require the FDA to speed review of drugs, devices, and…

    Senator Cruz’s RESULT Act Unlikely to Achieve Results

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    rachelsachs

  • FDA

    FDA Releases Report Detailing Problematic Laboratory-Developed Tests

    By Rachel Sachs Last week, the FDA issued a report presenting 20 case studies of laboratory-developed tests (LDTs) that have or may have harmed patients, in support of its ongoing efforts to impose greater regulatory…

    FDA Releases Report Detailing Problematic Laboratory-Developed Tests

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    rachelsachs

  • Generic Drugs

    Generic Drug Price Increases: Implications for Medicaid

    By Rachel Sachs The internet (not just the health policy part of the internet!) is fascinated by today’s New York Times story about dramatic recent increases in the costs of many decades-old drugs.  The story…

    Generic Drug Price Increases: Implications for Medicaid

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    rachelsachs

  • Bioethics

    Induced Infringement in Patent Law and the Doctor-Patient Relationship

    By Rachel Sachs Regular readers of this blog will recall that I often think and write about the interaction between the induced infringement doctrine in patent law and medical method patents of various kinds (previous…

    Induced Infringement in Patent Law and the Doctor-Patient Relationship

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    rachelsachs