Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
I. Regulations, Notices, & Guidance
- On August 27, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Male Breast Cancer: Developing Drugs for Treatment. This draft guidance provides recommendations regarding the development and labeling of cancer drugs, including biological products, regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of male patients with breast cancer. Specifically, this draft guidance recommends the inclusion of male patients in clinical trials of breast cancer drugs and provides recommendations on clinical development when males have either not been included in clinical trials for drugs to treat breast cancer or when inclusion of males in those trials is very limited. The development of drugs for male breast cancer may provide clinical data and additional FDA-approved treatment options to improve the clinical management of breast cancer in male patients.
- On August 28, 2019, FDA issued guidance entitled, Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products. This guidance provides recommendations to industry about using placebos and blinding in randomized controlled clinical trials in development programs for drugs or biological products to treat hematologic malignancies and oncologic diseases regulated by CDER and CBER. This guidance finalizes the draft guidance entitled “Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development,” issued August 24, 2018.
- On August 29, 2019, FDA issued guidance entitled, Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions. This guidance document describes FDA's current approach to considering uncertainty in making benefit-risk determinations to support certain FDA premarket decisions for medical devices—premarket approval applications (PMAs), De Novo requests, and humanitarian device exemption applications. This guidance document elaborates on the consideration of uncertainty as part of our overarching approach to a benefit-risk based framework that is intended to assure greater predictability, consistency, and efficiency through the application of least burdensome principles. This guidance also provides examples of how the principles for considering uncertainty could be applied in the context of clinical evidence and circumstances where greater uncertainty could be appropriate in premarket decisions, balanced by postmarket controls—PMAs for Breakthrough Devices and PMAs for devices for small patient populations.
- On August 29, 2019, FDA issued guidance entitled, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications. FDA developed this guidance document to provide greater clarity for FDA reviewers and industry regarding the principal factors FDA considers when making benefit-risk determinations during the premarket review process for certain medical devices. FDA believes that the uniform application of the factors listed in this guidance document will improve the predictability, consistency, and transparency of the premarket review process.
- September 9-11, 2019: The Health Resources & Services Administration (HRSA) announced a public meeting entitled, National Advisory Committee on Rural Health and Human Services. The National Advisory Committee on Rural Health and Human Services (NACRHHS) provides advice and recommendations to the Secretary of HHS on policy, program development, and other matters of significance concerning both rural health and rural human services. During the September 9, 2019, through September 11, 2019, meeting, NACRHHS will examine the current delivery of health care and human services in rural areas. Agenda items are subject to change as priorities dictate. Refer to the NACRHHS website for any updated information concerning the meeting.
- September 11-12, 2019: FDA announced a public workshop entitled, Food and Drug Administration Science Forum 2019. The purpose of the public workshop is to share with the public the unique scientific research and collaborative efforts of FDA’s 11,000 scientists and researchers, who use novel science and technologies to inform FDA’s regulatory decision-making and drive innovation.
- September 18, 2019: FDA announced a public workshop entitled, Implementing the Food and Drug Administration’s Predictive Toxicology Roadmap. The purpose of this public workshop is to highlight the work FDA has been doing to support and implement FDA’s Predictive Toxicology Roadmap.
- September 26, 2019: FDA announced a public meeting entitled, Joint Pediatric Advisory Committee and Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. During the meeting, committee members will discuss the pediatric-focused safety review for OxyContin (oxycodone hydrochloride) extended-release tablets, as mandated by the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), and to discuss pediatric data considerations for opioid analgesics labeling and Pediatric Research Equity Act studies for opioids generally, using Opana IR as an example.
- October 11, 2019: HRSA announced a public meeting entitled, Advisory Committee on Interdisciplinary, Community-Based Linkages. The Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL) provides advice and recommendations to the Secretary of HHS on policy, program development, and other matters of significance concerning activities under sections 750 – 760, Title VII, Part D of the Public Health Service Act. At this meeting, ACICBL members will discuss issues related to the pending Committee reports.
- October 16-17, 2019: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Community Preventive Services Task Force (CPSTF). The CPSTF is an independent, nonfederal panel whose members are appointed by the CDC Director. CPSTF members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health. Matters proposed for discussion during the upcoming meeting include: Cancer Prevention and Control; Obesity Prevention and Control; Pregnancy Health; and Tobacco Cessation.
- November 6-7, 2019: CDC announced a public meeting entitled, Clinical Laboratory Improvement Advisory Committee. The agenda will include agency updates from CDC, Centers for Medicare and Medicaid Services (CMS), and FDA. Presentations and discussions will focus on an update from the Association of Public Health Opioids Task Force; an update on the clinical laboratory workforce; return of research results to research participants; and improving integration of laboratory information systems with electronic health records. There will be an extended public comment session focusing on emerging technologies and the clinical laboratory. Agenda items are subject to change as priorities dictate.
- November 7, 2019: FDA announced a public meeting entitled, Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs. The purpose of the public meeting is to solicit specific, actionable policy suggestions that could be implemented in the near-term by the review staff of the Center for Drug Evaluation and Research's (CDER's) Office of New Drugs to promote effective drug development programs without compromising FDA regulatory standards for the assessment of safety and effectiveness.
II. Congressional Hearings
There were no health-related hearings this week.
III. Reports, Studies, & Analyses
- On August 30, 2019, the Commonwealth Fund released a report entitled, Reducing Wasteful Spending in Employers’ Pharmacy Benefit Plans. Large self-insured employers and other health care plan sponsors are concerned about rising prescription drug costs. Formularies developed on their behalf by intermediaries like pharmacy benefit managers (PBMs) and health plans can ensure drug safety and support negotiating with manufacturers. But intermediaries can profit from these negotiations, creating financial incentives to include high-price drugs even if they offer little clinical value. This study analyzed drug utilization data from 15 self-insured plan sponsors—13 are members of the Pacific Business Group on Health (PBGH)—to estimate savings from reducing the use of drugs that cost more than their commensurate clinical value as compared to alternatives. The study found that reducing the use of high-cost, low-value drugs could lead to $63 million in annual savings across the 15 plan sponsors. This represented 3 percent to 24 percent of overall pharmacy spending, depending on a number of factors.
IV. Other Health Policy News
- On August 27, 2019, CMS launched a modernized and redesigned Medicare Plan Finder. The Medicare Plan Finder, the most used tool on Medicare.gov, allows users to shop and compare Medicare Advantage and Part D plans. There are more than 60 million people with Medicare coverage. The updated Medicare Plan Finder also provides them and their caregivers with a personalized experience through a mobile friendly and easy-to-read design that will help them learn about different options and select coverage that best meets their health needs. The new Plan Finder walks users through the Medicare Advantage and Part D enrollment process from start to finish and allows people to view and compare many of the supplemental benefits that Medicare Advantage plans offer. More information about this announcement can be found here.