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The Patient-Centered Outcomes Research Institute (PCORI) is seeking comments on its draft Methodology Report, proposing standards for the conduct of patient-centered outcomes research.  The report covers, among other things, the rationale for standards for patient-centeredness, prioritizing topics for research; choosing a study design; and for designing, conducting, and reporting research (including standards for adaptive and…

On January 20, 2012, the Obama Administration posted its Fall 2011 Regulatory Agenda, outlining its planned regulatory initiatives in a number of policy areas. Priorities for the Department of Health and Human Services (HHS) include, among many others:

  • Implementing Affordable Care Act (ACA) insurance reforms, including establishing Affordable Insurance Exchanges, establishing risk adjustment criteria

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On September 20, 2011, the House of Representatives approved H.R. 2005 and H.R. 1852.  H.R. 2005, the Combating Autism Reauthorization Act of 2011, provides funding for surveillance, education, early detection, intervention, and research related to autism, and operation of the Interagency Autism Coordinating Committee.  H.R. 1852, the Children’s Hospital GME Support Reauthorization Act, provides…

CMS and the HHS Office of the National Coordinator are hosting the first “Care Innovations Summit” in Washington, DC on January 26, 2012 to “showcase innovative work in care delivery and payment.”  Presentations will be delivered by “national thought leaders, senior government officials and visionary innovators,” who will provide information on opportunities for collaboration, funding,…

This post was written by Erin Janssen and Areta Kupchyk.

The HHS Office for Human Subject Protections (OHRP) and the Food and Drug Administration (FDA) are seeking comments on a joint draft document entitled “Guidance on Exculpatory Language in Informed Consent.” Among other things, the draft document:

  • Provides guidance on the regulatory prohibition

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This post was written by Erin Janssen and Areta Kupchyk.

On September 23, 2011, FDA released guidance entitled “Reproductive and Developmental Toxicities–Integrating Study Results to Assess Concerns.” The guidance describes an approach to estimating possible human developmental or reproductive risks associated with drug or biological product exposure when a finding of toxicity has…

This post was written by Erin Janssen.

On September 1, 2011, HHS published a notice extending the comment period for the advance notice of proposed rulemaking (ANPRM) on how current regulations for protecting human subjects might be modernized and revised to be more effective. That ANPRM, entitled “Human Subjects Research Protections: Enhancing Protections for…

This post was written by Erin Janssen.

On August 17, 2011, the FDA released its “Strategic Plan for Regulatory Science,” calling for a sweeping modernization of the science used in developing and evaluating products critical to the nation’s health, economy, and security. The plan addresses regulatory science, the science of developing new tools,…

On August 25, 2011, HHS published a final rule on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding is Sought and Responsible Prospective Contractors. The final rule revises 1995 standards on this subject in order to “update enhance the objectivity and integrity of the research process&rdquo…

On July 21, 2011, the Senate Judiciary Committee approved S. 27, the Preserve Access to Affordable Generics Act, which would prohibit certain so-called “pay-for-delay” agreements in patent litigation settlements in which a brand-name pharmaceutical company compensates a generic pharmaceutical company for delays in generic entry. On July 28, 2011, the House Energy and Commerce…

HHS is seeking comments on proposed data collection standards for race, ethnicity, sex, primary language, and disability status in population health surveys, as required by Section 4302 of the ACA.  Comments will be accepted until August 1, 2011. HHS also announced plans to begin collecting health data on lesbian, gay, bisexual and transgender populations. …

A number of Congressional panels have held hearings on health policy issues this month, and more are scheduled, including the following:

  • The House Energy and Commerce Committee has held hearings on: reauthorization of the Prescription Drug User Fee Act (PDUFA); the ACA’s Independent Payment Advisory Board (IPAB), which is charged with helping to contain Medicare

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The Government Accountability Office (GAO) has issued a report entitled “HHS Research Awards: Use of Recovery Act and Patient Protection and Affordable Care Act Funds for Comparative Effectiveness Research.” The report includes a more than 40-page listing of all comparative effectiveness research grants issued under the Recovery Act, including the entities that have received funding…

Recent Congressional health policy hearings have included: a House Ways and Means Health Subcommittee hearing on the Medicare program’s financial status; a Senate Finance Committee hearing on “Health Care Entitlements: The Road Forward“; a House Energy and Commerce Committee hearings examining the Medicare/Medicaid dual eligible population and the Medicare Secondary Payer program; and…