Alerts

FDA and Pharmacy Weekly Digest - February 13

Alerts / February 13, 2020
Food/Dietary Supplements

FDA Announces Proposed Information Collections – The Notice “announces the FDA information collection request from the OMB for a generic clearance that will allow FDA to use qualitative social/behavioral science data collection techniques (i.e., individual in-depth interviews (IDIs), small group discussions, focus groups, and observations) to better understand stakeholders’ perceptions, attitudes, motivations, and behaviors regarding various issues associated with food and cosmetic products, dietary supplements, and animal food and feed. Understanding consumers’, manufacturers’, and producers’ perceptions, attitudes, motivations, and behaviors plays an important role in improving FDA’s communications impacting these various stakeholders and in assisting in the development of quantitative study proposals, complementing other important research efforts in the Agency.”

Drugs

FDA Announces Advancements in Understanding Intentional Genomic Alterations in Animals – FDA stated, “Because we’re committed to fostering advances in this space, we take a risk-based approach to oversight. We want to ensure that the intentional genomic alterations in animals are safe for the animal, safe for people eating food products from the animal and that the alteration does what it’s intended to do. That’s why we encourage sponsors to participate in our Veterinary Innovation Program, which facilitates advancements in the development of innovative animal products by providing greater clarity in the regulatory process, encouraging development and research, and supporting an efficient and predictable pathway to approval.”

FDA Re-announces Public Meetings on Adverse Event Reporting – The meetings are meant “to provide the pharmaceutical industry and other interested parties with information on the plans, progress, and technical specifications to upgrade electronic submission standards for the premarket and postmarket safety surveillance programs managed by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). These meetings will focus on enhancements to electronic submission of Individual Case Safety Reports (ICSRs) in FAERS using ICH E2B(R3) standards.”

FDA Publishes Draft Guidance on Biosimilars – The draft guidance is meant to give “recommendations to applicants seeking licensure under section 351(k) of the Public Health Service (PHS) Act of a proposed biosimilar or proposed interchangeable biosimilar for fewer than all of the reference product’s licensed conditions of use. This guidance also provides recommendations on the submission of a supplement to a licensed 351(k) biologics license application (BLA) seeking to add a condition of use that previously has been licensed for the reference product to the labeling of a licensed biosimilar or interchangeable product, including considerations related to the timing of such submissions.”

FDA’s Office of Pharmacology Announces Annual Reports – The 2019 OCP and Division of Applied Regulatory Science (DARS) Annual Reports “highlight OCP’s important work towards a vision of improving public health by building and translating knowledge of drug-response into patient-centered regulatory decisions of the highest quality.”

FDA’s Office of Pharmaceutical Quality Releases Its Annual Report – The report outlines the office’s accomplishments in “drug assessment, inspection, surveillance, policy, and research.”

FDA Promotes Funding Opportunity for Collection of Dog and Cat Data – The Agency announced “a new Fiscal Year 2020 funding opportunity and Request for Applications to support the collection of data on antimicrobial use in dogs and cats. CVM has funded several ongoing studies to collect use data in food-producing animals and believes it is also important to collect data about the use of antimicrobial drugs in dogs and cats and how these use practices might contribute to the development of antimicrobial resistant bacteria.”

Medical Devices

FDA Grants Marketing Authorization to First Cardiac Ultrasound Software Using AI – The product “assist[s] medical professionals in the acquisition of cardiac ultrasound, or echocardiography, images.”

FDA Clarifies Role in Cell Phone Regulation – FDA clarified that it is responsible for “[c]onsulting with other federal agencies on techniques and programs for testing and evaluating electronic product radiation” and “[c]onsulting with other federal agencies on techniques and programs for testing and evaluating electronic product radiation.” FDA also released a “Review of Published Literature between 2008 and 2018 of Relevance to Radiofrequency Radiation and Cancer.”

Tobacco

FDA Focuses Enforcement Priority on Illegally Marketed ENDS – The Agency stated that it “intends to prioritize enforcement against certain illegally marketed flavored e-cigarette products, focusing on products that are particularly popular with youth and are easily accessible or marketed to them – such as flavored, cartridge-based e-cigarette products (other than tobacco and menthol).”

Pharmacy

CDC Provides Media Telebriefing on Coronavirus – The briefing provides an update on the CDC’s coronavirus response.

CMS Issues Proposed Rule on Medicare Advantage and Part D – CMS announced that the proposal “updates Medicare Advantage (MA or Part C) and the Medicare prescription drug benefit (Part D) program to give seniors more choices and lower out-of-pocket costs, and to encourage price transparency. The proposed rule is another step in lowering drug costs for seniors, increasing competition, and further advancing the Agency’s efforts to strengthen and modernize the popular MA and Part D programs. The proposed rule implements several changes stemming from federal laws related to the Part C and D programs—including the Bipartisan Budget Act of 2018 (BBA of 2018), the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the SUPPORT Act), and the 21st Century Cures Act (the Cures Act). The proposed rule also addresses the opioid epidemic across CMS programs and continues CMS’s Patients Over Paperwork initiative to reduce ‘red tape’ that depletes resources from our healthcare system.”

CMS Announces Advanced Notice of Methodology Changes for Certain Programs – The announcement stated, “On January 6, 2020, we released for comment proposed changes to the Part C risk adjustment model used to pay for aged and disabled beneficiaries with a comment deadline of March 6, 2020. In accordance with section 1853(b)(2) of the Social Security Act, we are now notifying you of additional planned changes in the MA capitation rate methodology and risk adjustment methodology applied under Part C of the Medicare statute for CY 2021. Also included with this notice are annual adjustments for CY 2021 to the Medicare Part D benefit parameters for the defined standard benefit. For CY 2021, CMS will announce the MA capitation rates and final payment policies no later than Monday, April 6, 2020, in accordance with the timetable required by section 1853(b), as established in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) and amended by the Securing Fairness in Regulatory Timing Act of 2015 (SFRTA) (Pub. L. 114-106). The Advance Notice of Methodological Changes is published no fewer than 60 days before the publication of the Rate Announcement and provides a minimum 30-day period for public comment.”

Authorship Credit: Lindsay P. Holmes

Baker & Hostetler LLP publications are intended to inform our clients and other friends of the firm about current legal developments of general interest. They should not be construed as legal advice, and readers should not act upon the information contained in these publications without professional counsel. The hiring of a lawyer is an important decision that should not be based solely upon advertisements. Before you decide, ask us to send you written information about our qualifications and experience.