United States: FDA And Pharmacy Weekly Digest - October 16, 2019

Food/Dietary Supplements

FDA Publishes Updates to Manufacturer Food Regulatory Program – The FDA made available “revised food safety standards for state regulatory programs that oversee food facilities that manufacture, process, pack, or hold foods. These regulatory program standards, known as the Manufactured Food Regulatory Program Standards (MFRPS), were first issued by the agency in May 2007 and are updated every three years. The 2019 changes include updates to defined terms, new appendices and job aides, as well as updates to the current standards.”

Drugs/Biologics

FDA Announces Approval of Migraine Treatment – The treatment is “for the acute (active but short-term) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults.”

FDA Approves Rare Disease Treatment – The FDA announced the approval of a treatment for the rare disorder erythropoietic protoporphyria. The FDA stated, “For patients who are suffering from erythropoietic protoporphyria, a rare disorder, exposure to light may be extremely painful. Prior to today’s approval, there were no FDA-approved treatments to help erythropoietic protoporphyria patients increase their light exposure … Today’s approval is one example of the FDA’s ongoing commitment to encourage industry innovation of therapies to treat rare diseases, and work with drug developers to make promising new therapies available to patients as safely and efficiently as possible.”

FDA Publishes Guidance on Investigational In Vitro Diagnostics in Clinical Trials – The guidance addresses the “optional streamlined submission process for determining whether use of an investigational in vitro diagnostic (IVD) in a clinical trial for an oncology therapeutic is considered significant risk (SR), nonsignificant risk (NSR), or exempt from investigational device exemption (IDE) requirements. If the IVD in the trial is determined to be SR in the streamlined process, the sponsor may need to submit an IDE to the appropriate center (Center for Devices and Radiological Health (CDRH) or Center for Biologics Evaluation and Research (CBER)) in addition to submitting an investigational new drug application (IND) to the appropriate center (Center for Drug Evaluation and Research (CDER) or CBER). FDA encourages sponsors to use the streamlined process described in this guidance when possible to reduce administrative burden on sponsors and FDA and to maintain the current level of regulatory review.”

Medical Devices

CDRH Announces Guidance Priorities for FY 2020 – CDRH published its FY2020 guidance priorities. Among its top priorities are finalizing guidance on the 510(k) third-party review program, the safer technologies program for medical devices, and clinical decision software. CDRH also plans for draft guidance documents addressing labeling for breast implants, management of cybersecurity in medical devices, and distinguishing between medical device servicing and remanufacturing.

FDA Approves Rapid Test for Ebola Detection – The FDA announced the approval of the first “rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid).”

FDA Releases Guidance Documents on Device Labeling – The FDA issued two guidance documents addressing labeling. The first addresses labeling consideration for intravascular catheter, wires and delivery systems. The second addresses labeling and performance testing recommendations for coronary, peripheral and neurovascular guidewires.

Tobacco

CDC Issues Guidance on Caring for Patients With Suspected E-cig Use Lung Injury – The Interim Guidance “provides a framework for health care providers in their initial assessment, evaluation, management, and follow-up of persons with symptoms of e-cigarette, or vaping, product use associated lung injury (EVALI).”

Pharmacy

California Enacts Law to Increase Access to HIV-Prevention Medication – The governor of California signed SB-159 into law. The law allows a pharmacist to provide patients with certain HIV preventive medications without a prescription.

HHS Issues Guide on Appropriate Dosage Reduction of Long-Term Opioids – The HHS Guide titled “HHS Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics” aims to advise “clinicians who are contemplating or initiating a reduction in opioid dosage or discontinuation of long-term opioid therapy for chronic pain. In each case the clinician should review the risks and benefits of the current therapy with the patient, and decide if tapering is appropriate based on individual circumstances.”

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