On September 2, 2015, sixteen federal departments and agencies, including the US Department of Health and Human Services (HHS) released a proposed rule to modernize regulations governing human research subjects under the Common Rule (45 C.F.R. Part 46). Under the current regulations, the Common Rule applies to all research involving human subjects that is conducted or supported by a federal department or agency that has adopted the policy. Subject to only specified exemptions, the proposed rule extends the Common Rule’s requirements to all clinical trials regardless of funding source if: (1) the clinical trial is not regulated by the FDA, and (2) is performed at a US institution that receives any support from a federal agency. Other major changes introduced in the proposed rule include:
Continue Reading Agencies Release Proposed Overhaul of the Common Rule

Congressional committees have held several hearings this week on health policy issues. On March 24, the Energy and Commerce Health Subcommittee held a hearing on the 340B drug pricing program. Also on March 24, the House Ways and Means Subcommittee on Oversight examined CMS’s use of the Fraud Prevention System (FPS) to identify and stop

On October 24, 2014, the HHS Office for Human Research Protections published a notice announcing that it is seeking comments on draft guidance for the research community entitled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” The guidance addresses risks to subjects that are presented by research evaluating risks

Congressional panels have held numerous hearings on health policy issues this month, including the following:

  • The House Energy and Commerce Committee held a series of hearings on its “21st Century Cures” initiative, focusing on personalized medicine, barriers to evidence development and communication, technological innovations, the patient perspective, and modernizing clinical trials. A separate hearing focused

On May 28, 2014 the House Energy and Commerce Subcommittee on Health approved by voice vote three bipartisan public health bills:

  • H.R. 4299, “Improving Regulatory Transparency for New Medical Therapies Act,” which is intended to improve the Drug Enforcement Agency scheduling process for new FDA-approved drugs under the Controlled Substances Act and the registration process

On September 10, 2013, HHS published a notice inviting comments on its Draft Departmental Strategic Plan for FY 2014–2018. The document details HHS strategies for achieving four strategic goals: (1) Strengthen Health Care, (2) Advance Scientific Knowledge and Innovation, (3) Advance the Health, Safety, and Well-Being of the American People, and (4) Ensure Efficiency, Transparency,

The Department of Health and Human Services (HHS) is seeking input on how institutional review boards (IRBs) should assess the risks of research involving randomization to one or more treatments within the standard of care for particular interventions, and what reasonably foreseeable risks of the research should be disclosed to research subjects as part

The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the ethical, legal, and social issues raised by “incidental findings” (e.g., information obtained from testing that was not its intended or expected object) that arise from genetic and genomic testing, imaging, and testing of biological specimens conducted in the clinical, research,

A number of recent Congressional hearings have focused on health policy issues, including the following:

  • A House Small Business Healthcare Subcommittee hearing on “Medicare’s Durable Medical Equipment Competitive Bidding Program: How Are Small Suppliers Faring?”
  • Senate Aging Committee hearings on “Implementing the Physician Payments Sunshine Act” and “Eliminating Waste and Fraud in Medicare: An Examination

The Patient-Centered Outcomes Research Institute (PCORI) has announced a series of workshops intended to obtain input from patients, caregivers, and other stakeholders on PCORI’s draft process for generating and selecting specific research topics:

  • On October 27-28, PCORI will host a workshop on “Transforming Patient- Centered Research: Building Partnerships and Promising Models,” focusing on the patient’s

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

On May 13, 2011, CMS published a second notice under Federal Acquisition Regulations announcing its intention to sponsor a Federally Funded Research and Development Center (FFRDC). The FFRDC is charged with facilitating the modernization of business processes and supporting systems and their operations. CMS will accept comments on the notice until July 5, 2011.  For background information,