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The Chairman of the House Ways and Means Subcommittee on Health is seeking comments on a draft bill, the Protecting Integrity in Medicare Act of 2014, that is “aimed at combating fraud, waste and abuse in the Medicare program.” The bill covers a range of Medicare and Medicaid policies, from establishing new alternative sanctions for technical physician self-referral violations to providing more flexibility in meeting durable medical equipment (DME) documentation requirements. Among other things, the bill would:
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Continue Reading Ways and Means Committee Seeks Comments on Medicare Program Integrity Bill

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

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On September 5, 2014, the FDA is holding a public meeting at the Washington Plaza Hotel, in Washington DC, to discuss current scientific and regulatory approaches to biomarker development, acceptance, and utility in the development of therapeutic products (e.g., drugs and biologics). Specifically, FDA will focus on (1) identifying challenges for biomarker applications in early-…

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

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The Food and Drug Administration (FDA) has announced the availability of a final guidance document which describes the qualification process for drug development tools (DDTs) intended for use, over time, in multiple drug development programs. DDTs are methods, materials, or measures that aid drug development. Examples of DDTs include biomarkers and patient reported outcome instruments.…

On December 10, 2013, CMS published its final rule updating Medicare physician fee schedule (PFS) rates and polices for calendar year (CY) 2014, which includes a 20.1% across-the-board cut in PFS rates in 2014 (down from 24.4% projected under the proposed rule). The cuts are largely due to the statutory Sustainable Growth Rate (SGR) update formula, although lawmakers are seeking agreement on legislation to block the automatic cuts. The rule also includes a number of significant Part B policy changes, including the following highlights:…
Continue Reading CMS Updates Medicare Physician Fee Schedule, Other Part B Policies for CY 2014

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,…

On May 9, 2013, the Food and Drug Administration (“FDA”) announced the availability of two new draft guidance documents answering common questions on FDA’s implementation of regulations related to access to investigational drugs. The first draft guidance, entitled “Charging for Investigational Drugs Under an IND – Qs & As,” addresses FDA’s implementation of…

In recent weeks, the Food and Drug Administration (FDA) has issued a number of new draft and final guidance documents on a range of issues, including financial disclosure by clinical investigators, medical device recalls, prescription drug labeling, and medical devices for pediatric uses. Highlights include the following:

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The FDA released draft guidance on January 3, 2013 entitled Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using eCTD Specifications. The guidance is being issued in accordance with the Food and Drug Administration Safety and Innovation Act, which amended to Federal Food, Drug, and Cosmetic Act…

The FDA is seeking comments on draft guidance related to clinical trial enrichment: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products. The document is designed to provide guidance to industry on enrichment strategies that can be used in clinical trials intended so support effectiveness and safety claims in…

The FDA has released two final guidance documents intended to help sponsors and investigators comply with safety reporting requirements for IND applications and bioavailability (BA) and bioequivalence (BE) studies: Safety Reporting Requirements for INDs and BA/BE Studies, and Safety Reporting Requirements for INDs and BA/BE Studies – Small Entity Compliance Guide. Comments regarding both…

The Food and Drug Administration (FDA) recently issued two draft guidance documents related to the conduct of clinical trials. The first draft guidance, Draft Guidance for IRBs, Clinical Investigators and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed is intended to…

This post was written by Erin Janssen.

The FDA has published a notice announcing the availability of draft guidance on “Considerations When Transferring Clinical Investigation Oversight to Another IRB.” This guidance discusses the regulatory responsibilities of institutional review boards (IRBs), clinical investigators, and sponsors when oversight of a previously approved…

FDA recently published a final rule that expands the scope of clinical investigator disqualification. Under the rule, when the FDA determines that an investigator is ineligible to receive one kind of test article (drugs, devices, or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application…

This post was written by Erin A. Janssen.

FDA has issued guidance in the form of a Small Entity Compliance Guide entitled “Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c).” This guidance is intended to help sponsors, investigators and Institutional Review Boards better understand new informed consent requirements. In…