In a March 11 advisory opinion the Department of Health and Human Services’ Office of Inspector General (“OIG”) permitted a medical device manufacturer to pay Medicare-reimbursable costs for subjects enrolled in a clinical trial sponsored by the manufacturer and involving the manufacturer’s therapy. The OIG indicated it would not impose administrative sanctions, despite the fact … Continue Reading
On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation.[1] Patient-reported outcome (PRO) instruments facilitate the systematic collection of how patients feel and function during a clinical trial. FDA recognizes this information as important because … Continue Reading
On June 17, the Food and Drug Administration (FDA) continued its efforts to mitigate COVID-19’s disrupting impact on clinical trials by issuing guidance on statistical considerations for changes to trial conduct (FDA previously relaxed restrictions on protocol modifications). As expected, public health measures designed to control COVID-19’s rapid emergence as a global pandemic—social distancing, travel … Continue Reading
As previously reported, President Obama has signed into law the 21st Century Cures Act (PL 114-255), which is intended to spur the discovery and availability of new medical treatments. Reed Smith has prepared a client alert summarizing the major drug, device, and biologic development and approval provisions contained in the Cures Act. The alert is … Continue Reading
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
On November 16, 2015, the House of Representatives approved HR 639, the Improving Regulatory Transparency for New Medical Therapies Act, clearing it for the President. The legislation would amend the Controlled Substances Act (CSA) to make procedural changes intended to improve the efficiency, transparency, and consistency of the Drug Enforcement Agency’s (DEA) process for scheduling … Continue Reading
On October 7, 2015, President Obama signed into law H.R. 1624, which amends the Affordable Care Act’s (ACA) definition of “small employer” by maintaining the definition of a small group market as 1-50 employees and thus reducing the number of employers covered by certain new health insurance coverage requirements set to go into effect in … Continue Reading
On October 20, 2015, the HHS Office of the Assistant Secretary for Health, Office for Human Research Protections (OHRP) is hosting a public town hall meeting to respond to questions related to its September 8, 2015 proposed rule that would modernize HHS regulations governing human research subjects under the Common Rule. The registration deadline for … Continue Reading
On September 28, 2015, the House of Representatives approved by voice vote S. 139, the Ensuring Access to Clinical Trials Act. This legislation would allow individuals to participate in clinical trials for rare diseases without counting the income earned from these trials against their eligibility for Medicaid and Supplemental Security Income. The legislation, which was … Continue Reading
Two Congressional committees are holding hearings this week on health policy issues. First, the Senate Health, Education, Labor and Pensions (HELP) Committee has scheduled a September 16, 2015 hearing on “Achieving the Promise of Health Information Technology: Improving Care Through Patient Access to Their Records.” The HELP Committee also will hold a September 17 hearing on “Biosimilar Implementation: … Continue Reading
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 … Continue Reading
Today the House Energy and Commerce Committee approved H.R. 6, the “21st Century Cures Act,” by a bipartisan, unanimous 51-0 vote. This major legislation is intended to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability … Continue Reading
On April 28, 2015, the federal Food and Drug Administration (FDA) finalized three guidances for industry on developing biosimilar drugs. The guidances, which follow the FDA’s first approval of a biosimilar drug in March, are intended to clarify both scientific and regulatory considerations for a broad range of stakeholders, including drug companies, in manufacturing biosimilars. … Continue Reading
As discussed on our Life Sciences Legal Update blog, the FDA has released draft guidance clarifying its acceptance of medical device clinical data from studies conducted outside of the United States. The draft guidance highlights special considerations that apply when using foreign clinical data, including applicability to populations within the US, and provides recommendations to … Continue Reading
As discussed on our sister blog, Life Sciences Legal Update, the FDA has published a notice soliciting comments on a draft guidance document on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products. The HHS Office for Human Research Protections (OHRP) also is considering whether to adopt … Continue Reading
On January 27, 2015, the House Energy and Commerce Committee released its “21st Century Cures Act” discussion draft, the product of a year-long, bipartisan effort by the Committee to accelerate the pace of medical cures in the United States. The nearly 400-page bill addresses a wide range of topics, including, among many other things: the … Continue Reading
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
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 associated with … Continue Reading
Earlier this summer, the Food and Drug Administration (FDA) issued a draft 42-page “Informed Consent Information Sheet” that provides guidance for institutional review boards (IRBs), clinical investigators, and clinical trial sponsors on complying with the Agency’s informed consent regulations. Once finalized, the draft guidance will supersede FDA’s previous Information Sheet on this topic, “A Guide … Continue Reading
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 … Continue Reading
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 … Continue Reading
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- … Continue Reading
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 for … Continue Reading
