FDA Stakeholder Update - October 31, 2019

Dear Colleague, FDA's Stakeholder Engagement Staff works to provide you with up-to-date information to further our commitment to advance public health and well-being.

FDA Announcements

USDA, EPA and FDA announce partnership with the Food Waste Reduction Alliance 

The U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the FDA announced a new partnership with the Food Waste Reduction Alliance, the latest effort in the Winning on Reducing Food Waste Initiative launched by the three federal agencies in 2018.

Through this Memo of Understanding, USDA, EPA and the FDA will formalize industry education and outreach efforts with the Grocery Manufacturers Association, the Food Marketing Institute, and the National Restaurant Association, the three founding partners of the Food Waste Reduction Alliance (FWRA). The FWRA represents three major sectors of the supply chain: food manufacturing, retail, and restaurant and food service. The Alliance pursues three goals: reducing the amount of food waste generated; increasing the amount of safe, nutritious food donated to those in need; and diverting food waste from landfills. [10/30/2019]

Statement on FDA’s new report regarding root causes and potential solutions to drug shortages

One of the FDA’s top priorities is to ensure that Americans have access to safe and effective medicines. Sometimes, for a number of reasons, shortages of certain medicines occur and the FDA works immediately with our public health partners and industry to minimize their impact on patients and restore the availability of these drugs. A shortage of just one critical drug can have a major impact on a patient’s health, which underscores why government and industry need to act quickly to prevent future shortages. [10/29/2019]

Digital submission of adverse event reports for investigational new drug applications reflects FDA’s ongoing modernization efforts

The FDA is taking steps towards requiring electronic submission of certain safety reports for products being evaluated by the FDA under an investigational new drug (IND) application into the FDA's Adverse Event Reporting System (FAERS). The planned process for submissions is outlined in a new draft guidance, and the FDA is also making available supporting technical specification documents. The changes will allow the FDA to access and review both pre- and post-market safety information in the same system and with the same data standard. [10/29/2019]

Recall and Safety Information Medication errors in veterinary patients In veterinary medicine, both animal drugs and human drugs can be used to treat animals.  Human drugs are commonly used to treat animals, and veterinary prescriptions for a human drug could also be filled and dispensed at a human pharmacy. While the use of human drugs opens up therapeutic options in veterinary medicine, it can also increase opportunities for medication errors to occur. FDA’s Center for Veterinary Medicine has updated its Veterinary Medication Errors page with new case examples from adverse event reports received by the Center.

Public Meetings/Workshops

Topic: Strategies to Improve Health Equity Amidst the Opioid Crisis

The FDA Office of Minority Health and Health Equity will host a public meeting, Strategies to Improve Health Equity Amidst the Opioid Crisis. The purpose of this public meeting is to share information and obtain the public's perspectives on the current opioid crisis and how it specifically affects minority and underserved populations across the country, approaches to prevent and treat opioid use disorder, and emerging research as it relates to improving care for racial and ethnic minority, underrepresented, and underserved populations, and how FDA can support those efforts.

You can register to attend in person or via webcast.

Date: November 21, 2019

Time: 9 AM - 4 PM ET

Location: Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr

1750 Rockville Pike, Rockville, MD 20852