Author

Rachel Sachs

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.
  • FDA

    Thoughtful CREATES Act May Help Speed Generic Drug Approvals

    By Rachel Sachs Earlier this week, a bipartisan group of Senators introduced the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, a bill designed to speed generic drug approvals (and thus lower drug…

    Thoughtful CREATES Act May Help Speed Generic Drug Approvals

  • Health Law Policy

    Our Current Pharmaceutical Payment System Isn’t Neutral

    By Rachel Sachs Last week, former Pfizer Global R&D head John LaMattina wrote another of his columns for Forbes, this one on the subject of pay-for-performance deals for pharmaceuticals.  These deals, in which insurers contract…

    Our Current Pharmaceutical Payment System Isn’t Neutral

  • Bioethics

    Divided Infringement in Patent Law and the Doctor-Patient Relationship

    By Rachel Sachs Regular readers of this blog (hi, Mom) will recall that I often think and write about the interaction between the divided infringement doctrine in patent law and medical method patents of various…

    Divided Infringement in Patent Law and the Doctor-Patient Relationship

  • Health Law Policy

    State Drug Price Cap Laws: How Do They Work?

    By Rachel Sachs Two weeks ago, I blogged here about various state bills designed to encourage transparency in the pharmaceutical industry, by requiring companies to disclose information about their research & development costs, marketing expenses,…

    State Drug Price Cap Laws: How Do They Work?

  • 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

  • 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

  • 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

  • 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

  • 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