FDA Releases Resources on Food Traceability Proposed Rule – The FDA released a resource to allow users to explore the results of the Risk-Ranking Model for Food Tracing used in the development of the Food Traceability List. This tool shows the methods and criteria used to score commodity-hazard pairs, and the results of that scoring, which was used to determine which foods to include on the Food Traceability List.
FDA Publishes List of Essential Medicines – The list identifies essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs. In total, there are 227 drug and biological product essential medicines and medical countermeasures, as well as 96 device medical countermeasures, included on the list. The critical inputs on the list include active pharmaceutical ingredients and components that possess unique attributes essential in assessing the safety and effectiveness of such products.
House Passes Bill to Limit Orphan Drug Exclusivity – If the bill becomes law as written, H.R. 4712 would require drug manufacturers to show that “there is no reasonable expectation that the cost of developing and making available” the drug in the United States would be recovered from U.S. sales within the first 12 years of marketing. The drug manufacturer seeking exclusivity would offer this evidence when applying for orphan drug exclusivity with the FDA.
FDA Issues Final Guidance on Microneedling Products – The guidance discusses how to determine whether a microneedling product meets the definition of a medical device. Specifically, this guidance provides factors the FDA considers when determining whether a microneedling product meets the definition of a medical device and examples of microneedling products that would and would not be devices. Further, it provides recommendations to manufacturers seeking to market these devices.
HHS OIG Issues Special Fraud Alert on Speaker Programs – The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) highlighted the fraud and abuse risks associated with the offer, payment, solicitation or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies. OIG urges companies to assess the need for in-person programs given the risks for fraud and abuse. This alert shows OIG’s commitment to investigating fraud cases. Pharmaceutical and medical device companies should consider fraud and abuse risk before sponsoring speaker programs.
Pharmacy Association Reports North Dakota Asked Supreme Court to Hear PBM Case – In August, the U.S. Court of Appeals for the 8th Circuit ruled that a 2017 North Dakota law regulating pharmacy benefit managers (PBMs) in the state is preempted by the federal Employee Retirement Income Security Act (ERISA). Reports indicate that North Dakota has filed a petition for a writ of certiorari, asking the Supreme Court to review this ruling. In October, the Court heard oral arguments in Rutledge v. PCMA. Also at issue is whether ERISA preempts a state’s authority to regulate PBMs. The upcoming Supreme Court ruling in this case will have the potential to affect state regulation of PBMs.
FDA Authorizes the First Fully At-Home COVID-19 Test – The test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of having COVID-19 by their healthcare provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages, but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only. As of today, 288 tests are authorized by the FDA under emergency use authorizations; these include 223 molecular tests, 58 antibody tests and seven antigen tests.