FDA Stakeholder Update - February 27, 2020

FDA Announcement

FDA Takes New Steps to Increase the Safety of Laparoscopic Power Morcellators when used in Gynecologic Surgeries Statement from - Jeffrey E. Shuren, MD, JD, Director, CDRH  We are taking several important steps to make the use of laparoscopic power morcellators (LPMs) safer in gynecologic surgeries, including granting marketing authorization for updated labeling of the PneumoLiner containment system (a device that contains tissue to be morcellated during certain gynecologic surgeries), releasing a draft guidance recommending the addition of specific safety information to the product labeling for LPMs, and issuing a Safety Communication recommending that an LPM only be used in certain gynecologic surgeries with a containment system that is compatible with the LPM. [2/25/2020] FDA Enhances Purple Book to Support Transparency in Biosimilars The FDA is upgrading the Purple Book, otherwise known as the “Database of FDA-Licensed Biological Products,” in phases, starting today, with full search functionality for all approved biosimilar products and their reference products. Subsequent phases are expected to expand the data set to include data and information about all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products. [2/24/2020]

Coronavirus Update FDA takes steps to ensure quality of foreign products Statement from - Stephen M. Hahn MD, Commissioner, Food and Drug Administration; Judith A. McMeekin Pharm.D., Associate Commissioner, Office of Regulatory Affairs

Recently, we provided an update on FDA-wide activities we are engaged in related to the novel coronavirus outbreak: COVID-19. We continue to take a multi-pronged approach to this public health emergency, including focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for

potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools, including enforcement tools to stop fraudulent activity as we oversee the safety and quality of FDA-regulated products for American patients and consumers. [02/24/2020]

FDA Voices Serving Public Health Paramount in a Successful 2019 for FDA’s Generic Drug Program By: Sally Choe, Ph.D., Director, Office of Generic Drugs, Center for Drug Evaluation and Research (pictured - bottom right ) Safe, effective, high-quality generic drugs play a vital role in the U.S. health care system. FDA-approved generic drugs account for more than 90% of the prescriptions dispensed in the U.S. Affordable access to medicines is a public health priority, and competition from generic drugs can help reduce prices and improve patient and consumer access.

In 2019, the FDA’s Office of Generic Drugs worked diligently to ensure that the generic drug program continued to serve the public health. Our accomplishments for the year include a total of 1,014 generic drug final and tentative approvals. Of these approvals, 110 were for complex generic drugs, which are harder to develop and traditionally have lacked competition in the marketplace.  [2/19/2020]

Recall and Safety Information

Update: Reduce the Risk of Cardiac Surgery Infection While Using the LivaNova Heater-Cooler System 3T The FDA is reminding health care providers and staff of ways to reduce the risk of cardiac surgery infection when using the LivaNova Heater-Cooler System 3T. This is an update to our safety communication issued in October 2018. As noted in the October 2018 safety communication, LivaNova issued a Medical Device Correction letter to health care facilities to: Provide updated instructions to monitor the concentration of hydrogen peroxide in the water circuit to verify that enough concentration of hydrogen peroxide is present to limit microbial growth and to adjust the concentration of hydrogen peroxide if it drops below 100 ppm. Announce the availability of a design upgrade, called the 3T Aerosol Collection Set (vacuum canister and internal sealing), to reduce (but not eliminate) the risk of potential emission of aerosols from the 3T System.

Outbreak Investigation of E. coli O103: Clover Sprouts (February 2020) FDA, along with CDC and state and local partners, are investigating an outbreak of 14 illnesses caused by E. coli O103 in Iowa, Illinois, Missouri, Texas and Utah. CDC is reporting that the epidemiologic evidence indicates that clover sprouts from Jimmy John’s restaurants are a likely source of this outbreak.   The CDC is recommending that consumers who have recently eaten clover sprouts on a sandwich from Jimmy John’s restaurants and who are experiencing symptoms of E. coli infection, such as severe stomach cramps, diarrhea, fever, nausea, and/or vomiting, should contact their doctor and report their illness to their local health department. If consumers have a leftover sandwich with clover sprouts from Jimmy John’s, do not eat it and throw it away. [02/26/2020]

Request for Comment

Request for Information on Vaping Products Associated With Lung Injuries by April 20, 2020 The FDA is opening a docket to obtain data and information related to the use of vaping products that are associated with recent lung injuries. This request for information (RFI) responds to direction from Congress to gather information from the public that could help identify and evaluate additional steps the Agency could take to “address the recent pulmonary illnesses reported to be associated with the use of e-cigarettes and vaping products.”

Food Standards; General Principles and Food Standards Modernization; Reopening of the Comment Period until April 21, 2020 The FDA  is reopening the comment period for the proposed rule, published in the Federal Register of May 20, 2005, entitled “Food Standards; General Principles and Food Standards Modernization,” to establish a set of general principles for food standards for FDA to use when considering whether to establish, revise, or eliminate a food standard.

Public Meetings and Workshops

Patient-Focused Drug Development (PFDD) for Stimulant Use Disorder Date: March 10, 2020 Time: 12:30 PM - 5:00 PM ET Location: Silver Spring Civic Building, 1 Veterans Plaza, Silver Spring, MD 20910 Agenda: This meeting will provide FDA the opportunity to obtain input from individuals who are struggling or have struggled with the use of cocaine, methamphetamine, crystal meth, or misuse of prescription stimulants such as Adderall or Ritalin. Family members, advocates, caregivers and other stakeholders are encouraged to participate and share their views on the condition. Register: If you wish to attend in-person or via webcast, please register at Eventbrite. Patient-Focused Drug Development (PFDD) for Vitiligo Date: March 30, 2020 Time: 1:00 PM - 5:00 PM ET Location: FDA White Oak Campus: The Great Room Conference Center, 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, MD 20993 Agenda: The FDA is interested in hearing patients’ perspectives on the impact of vitiligo on daily life and patient views on treatment approaches. Register: If you wish to attend in-person or via webcast, please register at Eventbrite.

For a more comprehensive list of public meetings involving the FDA, please visit here.