Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

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 and uniform manner. Although the NIH is currently reviewing public comments on a proposed rule pertaining to researchers' conflicts, the OIG notes that that the proposal would not address institutional conflicts. 

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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 advocacy organizations on the state of informatics for consumer health. Information of interest includes journal articles, funding opportunities, and product development plans that can be shared publicly on a consumer health-related web site. Content areas may include care coordination, eHealth tools and strategies, early prevention and detection, electronic health records, clinical decision support, health care disparities, and telehealth/telemedicine. Comments should be submitted by February 1, 2011.

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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, and to assist practitioners, patients and policymakers to come to the right personalized decisions.” Among other things, the conference will review case studies on particular treatments for medical conditions that pose difficult questions about what kinds of research, methods, and analyses should be used to address limitations in current evidence for interventions and tests being examined by decision-making bodies. The registration deadline is November 17, 2010.

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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 Office of Inspector General (OIG) discussed its plans to launch a program later this year to conduct compliance training programs for providers, compliance professionals, and attorneys on ways methods to identify fraud risk areas and compliance best practices to enable providers to strengthen their compliance efforts. Other recent Congressional hearings have focused on “Promoting the Development of Antibiotics and Ensuring Judicious Use in Humans" and the “National Institutes of Health in the 21st Century.”
 

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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 effective institutional oversight and management of investigators’ financial conflicts of interests. HHS is proposing these changes in light of the increasingly complex interactions among the government, research institutions, and private sector entities involved with biomedical and behavioral research. HHS will accept comments on the proposed rule until July 20, 2010.

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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 with safety problems related to foods and animal drugs.

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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 Leadership Council, will seek to increase the consideration of regulatory issues early in the development of new technologies and therapies. In addition, the agencies jointly will issue grants totaling almost $7 million to develop better approaches to evaluating safety and efficacy for the development of new technologies and therapies. Additional information is available here. 

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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 Amendments Act of 2007, sponsors of “applicable clinical trials” are required to submit information for listing in the NIH clinical trial database. The proposed rule would require all informed consents for such “applicable clinical trials” – including specified drug, biologic, and device clinical investigations -- to include language informing the subject of the potential disclosure of the de-identified data to the clinical trials database (www.clinicaltrials.gov). FDA is accepting comments on the proposal until March 1, 2010.

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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' discretion to determine which of their significant financial interests are related to their research and are therefore required to be reported. The OIG also found that nearly half of grantee institutions do not require researchers to disclose specific amounts of equity or compensation, and researcher-submitted financial interest information is not routinely verified. The OIG also found problems with documentation supporting grantee institutions’ oversight of financial conflicts of interest; failure of the majority of grantee institutions to have policies and procedures that address subgrantee compliance with financial conflicts of interest regulations; inconsistent reporting of conflicts; and the lack of a requirement that grantee institutions report to NIH any financial interests that they have with outside companies. According to the OIG, the most common type of financial conflict of interest among researchers is equity ownership in companies in which the financial interests could significantly affect the research. Other financial conflicts of interest among researchers involved inventing technology, consulting, or holding positions with outside companies. The OIG recommended a series of steps address such financial conflicts of interest, including strengthened grantee institution reporting and oversight requirements, the development of NIH guidance on methods to verify researchers' financial interests, and expanded NIH oversight and regulations addressing financial conflicts of interest.

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On August 7, 2009, the Senate confirmed Dr. Francis Collins as Director of the National Institutes of Health.

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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 will fund such research, and seek to ensure that NIH-funded stem-cell research “is ethically responsible, scientifically worthy, and conducted in accordance with applicable law.” The guidelines are effective July 7, 2009.

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