BakerHostetler FDA and Pharmacy Weekly Digest - December 31, 2018

Alerts / December 31, 2018
Food/Dietary Supplements

FDA Commissioner Announces Ongoing Services During the Partial Government Shutdown – The FDA released a statement that certain programs would continue to run during the shutdown. Specifically, the FDA stated, “During the lapse period, the agency will be continuing vital activities, to the extent permitted by the law, that are critical to ensuring public health and safety in the United States. The mission critical, public health activities that will continue include, among other things: maintaining core functions to handle and respond to emergencies – such as monitoring for and quickly responding to outbreaks related to foodborne illness and the flu, supporting high-risk food and medical product recalls when products endanger consumers and patients, pursuing civil investigations when we believe public health is imminently at risk and pursuing criminal investigations, screening the food and medical products that are imported to the U.S. to protect consumers and patients from harmful products, and addressing other critical public health issues that involve imminent threats to the safety of human life.”

FDA Releases Annual Report on Antimicrobials for Use in Food-Producing Animals – The FDA issued a report on antimicrobials sold or distributed in 2017 for use in food-producing animals. The report shows “domestic sales and distribution of all medically important antimicrobials intended for use in food-producing animals decreased by 33 percent between years 2016 and 2017.”

Food Manufacturer Stops Operations After Repeat Violations – The FDA released a statement that a Michigan-based food facility would shut down following a number of inspections which found the presence of Listeria monocytogenes. The facility produces ready-to-eat foods including prepared salads, dips, and sauces.

FDA Updates Romaine Lettuce Investigation – The FDA continues to investigate a multistate outbreak of E. coli linked to romaine lettuce in California, including the recall of products that “may have come into contact with water from the water reservoir where the outbreak strain was found.”


During Partial Shutdown, FDA Will Continue to Review Certain Applications – Many FDA programs have been stalled during the partial shutdown; however, the Commissioner tweeted that “New GDUFA submissions that'll be processed with carryover user fees include: CBE and prior approval supplements, amendments, annual reports, applications for PET drugs, and general correspondence…#FDA will also be accepting Drug Master Files, including Type II Active Pharmaceutical Ingredient (API) DMFs, to be referenced in generic drug applications. However, we can't conduct initial completeness assessments on Type II API DMFs if the fee hasn’t been already paid.”

FDA Issues Guidance on Clinical Trial Endpoints – The FDA released a guidance entitled “Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.” The purpose of the guidance is to provide “recommendations to applicants on endpoints for cancer clinical trials submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications.” Per the FDA’s press release, the guidance is “part of FDA’s strategy to continue to encourage the modernization of clinical trials, we’re providing new recommendations for drug developers regarding the most effective clinical trial endpoints to help advance the development of products to treat cancer.”

FDA Releases Statement on Farm Bill – Shortly after the Farm Bill was signed into law, the FDA issued a statement about its impact. Specifically, the FDA reiterated that it “continue[s] to be concerned at the number of drug claims being made about products not approved by the FDA that claim to contain CBD or other cannabis-derived compounds. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce.” With respect to foods, FDA stated “it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.”

FDA Celebrates One Year of the Patient Affairs Staff – the FDA announced that this month, the Patient Affairs Staff has been in place for one year. The Patient Affairs Staff’s purpose is “to widen the entryway to the FDA for patients and their caregivers, which includes providing several ways for them to sit down with reviewers and inform the work we do.” Along with the anniversary, FDA released a “Patient Matter.”

Medical Devices

FDA Issues Guidance on Breakthrough Devices Program – The FDA issued a final guidance on its plans to implement the Breakthrough Devices Program created by the 21st Century Cures Act. Per the guidance, the Program “is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” Its purpose is to “help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.”

FDA Proposes to End Unique Device Identification Grace Period – The FDA opened a docket to receive comments related to its proposal to end the current 30-day grace period for submitting Device Identifier Records to the Global Unique Device Identification Database. The FDA proposes to end the current grace period and revert back to the seven day grace period that was previously available. Comments may be submitted until Jan. 18, 2019.

FDA Announces Guidance on Manufacturing Site Change Supplements – The FDA released a final guidance related to change supplements to manufacturing sites submissions. The guidance clarifies what constitutes a manufacturing site change requiring the submission of a PMA supplement, the documentation required to submit a site change supplement, and factors the FDA will consider when determining to inspect a facility prior to approval of a site change.

FDA Releases Guidance on Radiation Control Regulations – The FDA issued a draft guidance to assist manufacturers of diagnostic x-ray equipment. The guidance is intended to clarify the federal regulations that apply to diagnostic x-ray systems and components of those systems.


FDA Commissioner Requests Meeting with E-Cig CEOs – FDA Commissioner Gottlieb tweeted to e-cig companies asking them to “meet to discuss commitments they made last month, and why some are changing course. This is an urgent matter. We're at a critical juncture. The opportunity for harm reduction for adults could be lost for a generation.”


Treasury Department Release Report to President – The Department of Health and Human Services (HHS) in collaboration with the Departments of the Treasury and Labor and the Federal Trade Commission released a report to the President that “describes the influence of state and federal laws, regulations, guidance, and policies on choice and competition in health care markets and identifies actions that states or the Federal Government could take to develop a better functioning health care market.”

Cigna and Express Scripts Announce Merger – Cigna and ESI announced the closing of a multibillion dollar merger on Dec. 20, 2018. Cigna’s CEO stated, “Today’s closing represents a major milestone in Cigna’s drive to transform our health care system for our customers, clients, partners and communities. Together, we are establishing a blueprint for personalized, whole person health care, further enhancing our ability to put the customer at the center of all we do by creating a flexible, open and connected model that improves affordability, choice and predictability. By approaching each individual as a whole person – body and mind as one – we are empowering and supporting customers to take control of their total health and well-being.”

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