News and information useful to Cleveland State College of Law students, faculty and staff.

Archive for the ‘Health law’

FDA National Strategy to Further Increase U.S. Infant Formula Market Resiliency

image of baby bottleThe U.S. Food & Drug Administration (FDA) recently released an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market.  The Food and Drug Omnibus Reform Act of 2022 directed the FDA to work with the Department of Agriculture and other relevant government agencies to develop “a national strategy on infant formula to increase the resiliency of the infant formula supply chain, protect against future contamination, and other potential causes of supply disruptions and shortages, and ensure parents and caregivers have access to infant formula and information they need.” [See Pub. L. No. 117-328, Title III, Subtitle D, § 3401(j), 12/29/2022.]  This legislation responded to the extreme infant formula shortage in early 2022, when supply chains were stressed by the COVID-19 pandemic and exacerbated by Abbott Nutrition’s voluntary recall of infant formula products.  In 2024, with input from the National Academies of Sciences, Engineering, and Medicine, the FDA will issue a long-term national strategy “to improve preparedness against infant formula shortages by outlining methods to improve information-sharing, recommending measures for protecting the integrity of the infant formula supply chain, and preventing contamination.”  For more information, see the FDA Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market page.

FDA Draft Guidance on Development of Local Anesthetics with Prolonged Effect

photo of many pillsThe U.S. Food & Drug Administration (FDA) recently announced draft guidance for industry on the Development of Local Anesthetic Drug Products with Prolonged Duration of Effect.  Guidance recommendations “are intended to assist developers in generating the data necessary to support different indications and labeling claims for these drugs.”  Local anesthetic drug products have been used for pain relief following surgical procedures, but many are only effective for several hours.  “This guidance focuses on local anesthetic drug products that prolong the duration to a period of days,” and “is part of FDA’s efforts to reduce or eliminate the use of opioid analgesic drug products.”  To ensure agency consideration, comments should be submitted by June 14, 2023.  For more information, see the FDA draft guidance. [88 Fed. Reg. 16,265 (March 16, 2023)]

FDA Authorizes OTC At-Home Test to Detect Influenza & COVID-19 Viruses

Close up photo of cotton swabThe U.S. Food & Drug Administration recently announced an emergency use authorization (EUA) for the Lucira COVID-19 & Flu Home Test – the “first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as flu, and SARS-CoV-2, the virus that causes COVID-19.”  The Test can be bought without a prescription and is performed “using nasal swab samples self-collected by individuals ages 14 years or older or collected by an adult for individuals 2 years of age or older.”  A sample swab is swirled in a viral, the viral is placed in the test unit, and results are display in 30 minutes.  In individuals with symptoms consistent with a respiratory tract infection, the Test “correctly identified 99.3% of negative and 90.1% of positive Influenza A samples, 100& of negative and 88.3% of positive COVID-19 samples, and 99.9% of negative Influenza B samples.”  The Test’s EUA requires Lucira to continue to collect samples to study its ability to detect Influenza B.  For more information, see the 2/24/2023 FDA EUA letter.

2/17/2023 Journal of Law & Health Symposium

image of scales & caduceusThe CSU|LAW Journal of Law and Health is conducting its Spring Symposium 1pm-5pm, Friday, February 17th, 2023 in the College of Law Moot Court Room.  The Symposium topic is Health Care & Privacy Law Consequences Post Dobbs, and it has 3.75 hours CLE credit pending.  The keynote address will be “The Future of IVF Post Dobbs,” presented by Rebecca Feinberg, JD, MBe, MS.  The five panel topics will be “Confronting Post-Dobbs Criminalization and Data Privacy: State and Local Policy Responses,” “Abortion as Healthcare,” “Legal Risks Associated with Self-Managed Abortion,” “Practitioner Concerns Regarding Cybersecurity and Criminalization of Abortion,” and “Practitioner Perspective Regarding Changes in Law from Dobbs and Healthcare Compliance.”  Registration is $75.00; but free for Cleveland State University students, faculty and staff.  The Journal of Law and Health publishes articles from eminent authors in the field, surveys of recent legislative and judicial developments, reviews of significant publications, and notes and case comments from J. L. & Health staff.  Faculty advisors are Laura Hoffman, Abigail Moncrieff, and Brian Ray.

FDA Proposed Change to Assessment of Blood Donor Eligibility

photo of blood cellsThe U.S. Food and Drug Administration (FDA) recently proposed “a change from time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV.”  The draft recommendations are based on FDA’s review of “data from other countries with similar HIV epidemiology that have instituted this approach as well as ongoing surveillance of the U.S. blood supply.”  Proposed guidance changes include revising the donor history questionnaire to ask prospective donors about new or multiple sexual partners in the past three months, and the deferral of prospective donors who have had anal sex with new or multiple sexual partners in the past three months.  There is no proposed change to donor deferral time periods for other HIV risk factors (eg, non-prescription injection drug use), individuals who have tested positive for HIV or taken medication to treat HIV will continue to be deferred permanently, and blood establishments will still be required to test all blood donations for transfusion-transmitted infections (eg, HIV, hepatitis B, hepatitis C).  The FDA will receive comments on the proposed guidance until March 31, 2023 (see 88 Fed. Reg. 5894, 1/30/2023).  For more information on current questionnaires, see the Association for the Advancement of Blood & Biotherapies Blood Donor History Questionnaires page.