FDA Provides Update on Frozen Berry Sampling – The FDA stated, “As of September 30, 2019, the FDA has tested 339 domestic samples and 473 import samples of frozen berries. Of the frozen berries sampled, the FDA found genetic material from hepatitis A virus in five samples and genetic material from norovirus in eight samples, using multiple-laboratory validated RT-qPCR methods for the detection of hepatitis A virus and norovirus viral sequences in soft fruit. These 13 samples were then further tested by another method called Sanger sequencing to see if the viral material could be further characterized by examining a separate, distinct section of the viral genomes. Nine of the 13 samples could be further characterized using this technique. When the FDA detected genetic material from hepatitis A virus or norovirus in a sample, the agency notified the firm of the finding(s) and worked with them to take appropriate action to protect the public health. Testing for all pathogens is still underway and no conclusions can be drawn at this time.”
FDA Announces Need for Coronavirus Countermeasures – The FDA stated, “As part of FDA’s ongoing commitment to prepare and respond to infectious disease outbreaks, the agency is sharing updates on processes in place to help developers understand the pathways, including Emergency Use Authorization (EUA), that may be available to more rapidly advance and make medical countermeasures available for this virus, including diagnostic tests. The FDA is also issuing key information for the public to help support the timely development of medical products to respond to the current outbreak. In order to support efficient medical product development for novel coronavirus medical countermeasures, today the FDA is launching a landing page that provides key information for the public, including product developers, on the FDA’s efforts in response to this outbreak.”
FDA Encourages Innovation in Gene Therapy Product Development – The FDA announced the availability of six final guidance documents on gene therapy management and clinical development of gene therapy products. It also released a draft guidance entitled “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.”
FDA to Hold Public Meeting on Pharmaceutical Quality – On February 2, 2020, the FDA will hold a meeting “to explore and better understand how stakeholders perceive and value the quality of pharmaceutical products.”
FDA Publishes Biosimilar User Fee Guidance – The guidance outlines “the types of user fees authorized by BsUFA II, the process for submitting payments to FDA, the consequences for failing to pay BsUFA fees, and the process for requesting a reconsideration of a user fee assessment. This guidance also describes how FDA determines which products are subject to a fee and discusses certain changes to FDA’s policies under the new law. This guidance does not address how FDA determines and adjusts fees each fiscal year, nor does it address FDA’s implementation of other user fee programs (e.g., Prescription Drug User Fee Amendments, Generic Drug User Fee Amendments).”
FDA Releases Two Guidance Documents on Drug Interactions Studies – The guidance documents are “intended to assist drug developers in evaluating drug-drug interaction (DDI) potential during drug development and describe a systematic, risk-based approach to the assessment of DDIs. In patients who take more than one medication, a DDI can cause unexpected side effects resulting in adverse events or death. Drug interaction studies can provide information to inform clinical risk management strategies for patients taking more than one medication. These guidances reflect the FDA’s current thinking in helping drug developers inform DDI management strategies.”
FDA Publishes Results of Sunscreen Absorption Study – The FDA announced the publication of sunscreen absorption research in the Journal of the American Medical Association. The research provides “additional information about the absorption of the active ingredients in sunscreens into the body’s bloodstream after they are applied to the skin.”
FDA Expresses Concern About Cybersecurity Risks – The FDA issued a statement informing stakeholders of its concerns about the security of certain devices “primarily used in healthcare facilities for displaying patient information, such as the physiologic status (e.g., temperature, heartbeat, blood pressure) of a patient, and monitoring patient status from a central location in a facility, such as a nurse’s bay.” The FDA continued that the vulnerabilities could allow an attack to “occur undetected and without user interaction.”
FDA Announces Public Meeting on Cosmetics Containing Talc – On February 4, 2020, the FDA will hold a public meeting “to discuss and obtain scientific data and information on topics related to testing methodologies, terminology and criteria that can be applied to characterize and measure asbestos and other potentially harmful elongate mineral particles (EMPs) that may be present as contaminants in talc and consumer products, including cosmetics, containing talc as an ingredient.”
HHS Issues Final Rule to Help Stop Certain Controlled Substance Fills – The final rule changes the “requirements for the use of the Telecommunication Standard Implementation Guide, Version D, Release 0 (Version D.0), August 2007, National Council for Prescription Drug Programs, by requiring covered entities to use the Quantity Prescribed (460-ET) field for retail pharmacy transactions for Schedule II drugs…This modification is important to ensure the availability of a greater quantum of data that may help prevent impermissible refills of Schedule II drugs, which will help to address the public health concerns associated with prescription drug abuse in the United States.” The final rule will be effective March 24, 2020.
PBM Elimination Bill Introduced in Oklahoma Senate – Senate Bill 1901 stated, “The Oklahoma Employees Insurance and Benefits Board shall collaborate with the Oklahoma Health Care Authority by July 1, 2021, to eliminate the use of a third-party pharmacy benefit management company and replace this company with a direct-to-pharmacy payment system, the pricing of which shall be established jointly by the Board and Health Care Authority for the purposes of lowering the prescription drug prices for the benefit of the enrollees of any health insurance plan offered pursuant to the Oklahoma Employee Insurance and Benefits Act.”
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