Tag Archives: National Institutes of Health (NIH)

House and Senate Hearings Focus on Health Costs and Policy Issues

Congressional panels continue to focus on federal health care policy topics, including cost, quality, and program integrity issues. Recent hearings have included the following: The Senate Health, Education, Labor and Pensions (HELP) Committee held hearings entitled “Reducing Health Care Costs: Examining How Transparency Can Lower Spending and Empower Patients”; “Prioritizing Cures: Science and Stewardship at … Continue Reading

NIH Finalizes New Drug and Device Clinical Trial Reporting Requirements

The National Institutes of Health (NIH) has finalized the requirements for submitting clinical trial information for applicable clinical trials of drug products (including biological products) and device products on ClinicalTrials.gov. The rule is intended to clarify as well as establish additional procedures and requirements for submitting: (i) registration, (ii) summary results, and (iii) adverse event … Continue Reading

Senate HELP Committee Clears Bipartisan Biomedical Innovation, Health IT Bills

The Senate Health, Education, Labor and Pensions (HELP) Committee has approved several bipartisan health policy bills, including health information technology (HIT) legislation and bills aimed at spurring biomedical innovation to complement the “House 21st Century Cures” initiative. Specifically, on February 9, 2016, the Committee approved:… Continue Reading

President Obama Establishes “White House Cancer Moonshot Task Force” Led by VP Biden, Calls for $1 Billion Investment in Cancer Research

President Obama recently signed a memorandum formally establishing a White House Cancer Moonshot Task Force to coordinate and strengthen federal and private efforts to support cancer research and treatment.  The Task Force, which is chaired by Vice President Biden, is charged with developing recommendations to: accelerate understanding of cancer and its prevention, early detection, treatment, … Continue Reading

Senate HELP Committee Outlines Plans for Action on Biomedical Innovation Bills

The Senate Health, Education, Labor and Pensions (HELP) Committee has announced its plans to consider companion legislation to the House-approved “21st Century Cures Act,” which is intended to improve the drug and device development processes and expedite patient access to medical treatments.  The Senate currently plans three sessions to consider components of its biomedical innovation … Continue Reading

Revised House 21st Century Cures Bill Released Ahead of House Vote

Later this week, the House of Representatives is expected to consider the H.R. 6, the 21st Century Cures Act.  Ahead of the House vote, the House Rules Committee released a revised version of the bill with new funding offsets and other policy changes.  Notably changes in the newest version include: A provision excluding authorized generics … Continue Reading

OIG Issues 2015 Compendium of Unimplemented Recommendations

The OIG has released its March 2015 “Compendium of Unimplemented Recommendations,” which highlights the OIG’s top 25 recommendations for cost savings and/or quality improvements in HHS programs, along with other significant unimplemented recommendations. High-priority recommendations address the following areas, among others: Payment Policies and Practices: Expand the DRG window to include additional days prior to the inpatient … Continue Reading

March Congressional Health Policy Hearings

On March 10, 2015, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on “Continuing America’s Leadership in Medical Innovation for Patients,” featuring testimony from NIH Director Francis Collins, MD, PhD, and FDA Commissioner Margaret Hamburg, MD. On March 17, the HELP Committee has scheduled a hearing on “America’s Health IT Transformation: … Continue Reading

NIH Releases Proposed Rule on FDAAA Requirements for ClinicalTrials.Gov Registration and Results Submission

NIH has just released a proposed rule that would clarify and expand requirements for the submission of clinical trial registration and results information, including adverse event information, to the ClinicalTrials.gov database in conformance with the Food and Drug Administration Amendments Act of 2007 (FDAAA). The rule would implement the statutory requirement for the submission of … Continue Reading

OIG Examines Clinical Trial Data and Safety Monitoring Boards

The OIG has issued a report entitled “Data and Safety Monitoring Boards in NIH Clinical Trials: Meeting Guidance, But Facing Some Issues.” The report examines the effectiveness of data and safety monitoring boards (DSMB) – or committees of experts that provide ongoing reviews of clinical trial data to ensure the safety of study subjects and … Continue Reading

President Signs Government Funding Bill Maintaining FY 2013 Medicare Sequestration Cuts

On March 26, 2013, President Obama signed into law H.R. 933, a continuing resolution  that averts a government shutdown by funding the government through the remainder of fiscal year 2013 (through September 30, 2013). The funding bill is subject to the sequestration order triggered by the Budget Control Act, although funding was increased for a limited … Continue Reading

House, Senate Committee Votes on Health Research Measures

Congress has recently voted on a number of health research bills. On September 19, 2012, the House of Representatives approved H.R. 733, the “Recalcitrant Cancer Research Act of 2012,” which directs the National Cancer Institute to develop a long-term strategic plan for addressing cancers with a high mortality rate. The Senate HELP Committee approved a … Continue Reading

OIG Reports on Institutional Conflicts of Interest at NIH Grantees

The OIG has issued a report entitled "Institutional Conflicts of Interest at NIH Grantees." While noting that some National Institutes of Health (NIH) grantee institutions have voluntarily adopted institutional conflicts of interest policies, the OIG recommends that NIH promulgate rules to mandate that grantee institutions to identify, report, and address institutional financial conflicts in a consistent … Continue Reading

NCI Seeks Information on Evidence-Based Informatics Resources

The National Cancer Institute (NCI) has published a request for information (RFI) as part of a consumer health initiative to develop collaborations that produce evidence-based informatics resources that will aid providers in clinical settings and promote positive health behaviors among consumers. NCI is soliciting ongoing information from commercial information technology, government, health care, education, research, and … Continue Reading

NIH/AHRQ Conference on Methodological Challenges in Comparative Effectiveness Research (Dec. 2-3, 2010)

On December 2-3, 2010, the National Institutes of Health and the Agency for Healthcare Research and Quality are co-sponsoring a conference on “Methodological Challenges in Comparative Effectiveness Research.”  The meeting will explore new methodologic, design and evidentiary approaches that can help “ensure the credibility, validity and reliability of applicable research findings to a diverse population, … Continue Reading

Congressional Hearings on Health Care Fraud, Health Policy Issues

The House Ways and Means Subcommittees on Health and Oversight held a hearing June 15, 2010 on “Reducing Fraud, Waste and Abuse in Medicare.” At the hearing, witnesses from relevant government agencies reviewed recent enforcement efforts and key provisions of the new health reform law aimed at combating health care fraud. Of note, the HHS … Continue Reading

HHS Proposes Regulations on Financial Conflicts of Interest in Research

On May 20, 2010, HHS published a proposed rule to amend the Department’s regulations regarding the responsibility of applicants to promote objectivity in research for which Public Health Service (PHS) funding is sought. The proposed revisions are intended to expand and add transparency to investigator disclosure of significant financial interests and enhance regulatory compliance and … Continue Reading

FDA and NIH Launch Safety Reporting Website

This post was written by Paul Sheives. The FDA and the National Institutes of Health (NIH) have launched a website, called the Safety Reporting Portal (SRP), intended for the reporting of certain pre- and post-market safety data. In this early stage of development, industry can report adverse events occurring on human gene transfer trials, along … Continue Reading

FDA And NIH Announce Collaboration to Speed Patient Access to New Therapies

This post was written by Paul Sheives. FDA and the National Institutes of Health (NIH) have announced a new initiative aimed at improving efficiencies in translational science and regulatory science to close the gap in time between discovery of new technology and availability of therapies to patients. A new entity established under the initiative, the Joint … Continue Reading

Proposed Rule Amending Informed Consent Disclosure

This post was written by Paul Sheives. On December 29, 2009, the Food & Drug Administration Act (FDA) issued a proposed rule that would amend the informed consent regulations to require the addition of an element regarding disclosure of information to the National Institute of Health (NIH) clinical trials database. Under the Food and Drug Administration … Continue Reading

NIH Grantees’ Financial Conflicts of Interest Policies

The OIG has issued a report entitled “How Grantees Manage Financial Conflicts of Interest in Research Funded by the National Institutes of Health.” The OIG identified a number of vulnerabilities in National Institutes of Health (NIH) grantee institutions’ identification, management, and oversight of financial conflicts of interest. For example, 90% of grantee institutions rely solely on researchers’ … Continue Reading

NIH Stem Cell Research Guidelines

On July 7, 2009, the National Institutes of Health (NIH) published a notice its final “Guidelines for Human Stem Cell Research.” The guidelines, which implement President Obama’s March 9, 2009 Executive Order on federal funding for stem cell research as it pertains to extramural NIH-funded stem cell research, establish policy and procedures under which the NIH … Continue Reading