FDA and Pharmacy Weekly Digest - July 1

Alerts / July 1, 2019
Food/Dietary Supplements

FDA Issues Report on Certain Dog Foods – The Food and Drug Administration (FDA) continues to investigate cases of dilated cardiomyopathy (DCM) in dogs consuming certain dog foods. The FDA released the adverse event reports citing DCM and a list of dog food brands that are identified in those reports.


FDA Warns Companies Selling Unapproved Kratom – The FDA sent warning letters to two distributors of kratom products. The FDA alleges that the distributors are “illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. The companies also make claims about treating pain, as well as other medical conditions like depression, anxiety and cancer.”

FDA Comments on Stem Cell Clinic Permanent Injunction – On June 25, a judge issued a permanent injunction against a stem cell clinic, prohibiting it “from manufacturing or distributing any and all stromal vascular fraction (SVF) products, which are adipose (fat) tissue derived stem cell products, until they come into compliance with the law.” The FDA stated, it “sends a strong message to others manufacturing violative stem cell products. Court decisions like this reaffirm the FDA’s compliance and enforcement efforts in the ongoing fight to protect the public from individuals and clinics who mislead patients with unapproved and potentially harmful medical products. The agency will continue to take steps – such as issuing warning letters or initiating court cases – against those who endanger patients’ health with inadequate manufacturing conditions or by manufacturing and marketing products without the submission of appropriate applications containing safety and efficacy information to the FDA.”

FDA Publishes Guidance on Bioanalytical Method Validation – The FDA issued a draft guidance titled “M10 BIOANALYTICAL METHOD VALIDATION.” The guidance provides “recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples.”

FDA Releases Guidance on Safety Data Collection – The FDA published a draft guidance titled “E19 OPTIMISATION OF SAFETY DATA COLLECTION.” The guidance provides “internationally harmonised guidance on when it would be appropriate to use a selective approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemented.”

FDA Issues Guidance on Drug Endpoints – The FDA released a draft guidance titled “Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry.” The FDA stated, “This guidance has two purposes: 1) to make it clear that an effect on symptoms or physical function, without a favorable effect on survival or risk of hospitalization, can be a basis for approving drugs to treat heart failure; and 2) to provide recommendations to sponsors on the need to assess mortality effects of drugs under development to treat heart failure.

Medical Devices

FDA Expresses Insulin Pump Cybersecurity Concerns – The FDA issued a warning to providers and patients concerning certain insulin pumps that pose cybersecurity risks. The pumps are being recalled. The FDA stated, “[D]ue to cybersecurity vulnerabilities identified in the device, someone other than a patient, caregiver or health care provider could potentially connect wirelessly to a nearby … insulin pump and change the pump’s settings. This could allow a person to over deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or to stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis (a buildup of acids in the blood).”

FDA Issues Guidance on Clinical Investigations – The FDA released a draft guidance titled “Clinical Investigations for Prostate Tissue Ablation Devices.” The draft provides “recommendations for (1) complying with the clinical testing special control under 21 CFR 876.4340(b)(8) for premarket notifications (510(k)s) for high intensity ultrasound systems for prostate tissue ablation, and (2) collecting clinical data to support marketing submissions for new types of prostatic tissue ablation devices.”

FDA Finalizes Diagnostic Ultrasound Systems Guidance – The FDA published a final guidance titled “Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.” The guidance outlines “recommendations for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. In addition to outlining regulatory approaches for certain diagnostic ultrasound devices, this guidance document describes the types of modifications to a diagnostic ultrasound device for which FDA does not intend to enforce the requirement for a new premarket notification (510(k)).


FDA Provides Educational Materials to Retailers – The FDA released free digital calendars to educate retailers about the illegal sales of e-cigarettes and other tobacco products. The FDA stated, “Retailers play a critical role in keeping harmful and addictive tobacco products like e-cigarettes out of the hands of America’s youth. Unfortunately, there are retailers who continue to illegally sell these products to kids, which is especially concerning since tobacco use is almost always initiated and established during adolescence.


CDC Issues Global Notice on Measles – The Centers for Disease Control and Prevention (CDC) published a global measles outbreak notice reminding travelers that “measles outbreaks are now occurring in multiple countries around the world, meaning that the number of measles cases is higher than normal for those countries. Unvaccinated travelers infected with measles overseas have brought the disease back to the United States, causing outbreaks among unvaccinated people in their local communities.” The CDC urged travelers to get vaccinated.

Trump Signs Drug Price Transparency Executive Order – President Donald Trump signed Executive Order 13877, titled “Improving Price and Quality Transparency in American Healthcare To Put Patients First.” The executive order has a number of requirements, including requiring that the Department of Health and Human Services (HHS), within 60 days, propose a regulation “to require hospitals to publicly post standard charge information.” Within 90 days, HHS, the Treasury and the Department of Labor must publish an advanced notice of proposed rulemaking “soliciting comment on a proposal to require healthcare providers, health insurance issuers, and self-insured group health plans to provide or facilitate access to information about expected out-of-pocket costs for items or services to patients before they receive care.” Within 180 days, HHS must “issue a report describing the manners in which the Federal Government or the private sector are impeding healthcare price and quality transparency for patients, and providing recommendations for eliminating these impediments in a way that promotes competition. The report should describe why, under current conditions, lower-cost providers generally avoid healthcare advertising.”

FDA Warns Providers and Patients Not to Use Certain Sterile Products – The FDA announced a warning to “patients and health care professionals not to use products intended to be sterile produced by Pacifico National Inc., doing business as AmEx Pharmacy, Melbourne, Florida, due to a lack of sterility assurance. These drugs may pose a safety risk to patients. Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening infections or death.”

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.