Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry
Congressional panels continue to focus on federal health care policy topics, including cost, quality, and program integrity issues. Recent hearings have included the following:
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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 information for such applicable clinical trials.
According to NIH, the expanded registry and results data bank will “help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research.” Among other things, the final rule:
Continue Reading NIH Finalizes New Drug and Device Clinical Trial Reporting Requirements
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 Senate HELP Committee Clears Bipartisan Biomedical Innovation, Health IT Bills
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:
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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…
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:
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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:
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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…
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…
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…
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…
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…
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 …
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,…
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,…
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…
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…
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,…
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…
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…
