Stakeholder Update - July 19, 2019

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

FDA Statements

Statement on the agency’s actions to tackle the epidemic of youth vaping and court ruling on application submission deadlines for certain tobacco products, including e-cigarettes Late last week, a U.S. District Court judge in Maryland issued a decision that, among other things, requires makers and importers of e-cigarettes and other electronic nicotine delivery systems (ENDS) and certain other tobacco products like cigars, pipe tobacco and hookah to submit applications for their currently marketed products to the agency within 10 months. [July 15, 2019] Consumer Update

Some Medicines and Driving Don’t Mix If you’re taking a medication, is it safe to drive? Most likely, yes. Still, the FDA advises you to make sure before operating any type of vehicle, whether a car, bus, train, plane, or boat. Although most medications won’t affect your ability to drive, some prescription and over-the-counter (OTC) drugs (also called nonprescription medicines) can have side effects and cause reactions that may make it unsafe to drive. [July 18, 2019]

FDA Voices

Preventing Medical Device Shortages by Ensuring Safe and Effective Sterilization in Manufacturing By: Suzanne B. Schwartz, M.D., M.B.A., Deputy Director of the Office of Strategic Partnerships and Technology Innovation and Acting Office Director, Center for Devices and Radiological Health (CDRH), and CAPT Elizabeth F. Claverie-Williams, M.S., Microbiologist and Branch Chief, Infection Control Devices Branch, CDRH

Medical device shortages are a serious public health issue and can be particularly detrimental if they occur with life-saving, life-sustaining, or critical devices. As the federal agency that regulates medical devices, among other products, the FDA is particularly attuned to this issue and works to monitor potential problems. Medical devices that are sterilized to remove potentially harmful germs and other microorganisms are critical to the American health care system. The FDA is particularly aware of issues relating to sterilization during manufacturing—and the potential device shortages that can occur if there are problems during this process. [July 15, 2019]

Ensuring Patient Safety and Drug Manufacturing Quality Through Partnership with European Union Regulators By: Anna K. Abram, Deputy Commissioner for Policy, Legislation and International Affairs, and Mark Abdoo, Associate Commissioner for Global Policy and Strategy As drug manufacturing has globalized, ensuring that companies meet the FDA strict standards for producing safe, effective and high-quality medicines has become increasingly challenging. One way the FDA has addressed this challenge is through the Mutual Recognition Agreement (MRA) with the European Union (EU), which allows us to more effectively deploy our inspectional resources across the globe. FDA Deputy Commissioner for Policy, Legislation and International Affairs, Anna AbramAnna K. Abram Pharmaceutical establishments that make active pharmaceutical ingredients and finished drug products used by U.S. patients are subject to routine inspections by the FDA to determine if they are in compliance with Current Good Manufacturing Practices (CGMP). [July 11, 2019]

How the FDA Uses Science to Speed Medical Device Innovation By: Ed Margerrison, Ph.D., Director, Office of Science and Engineering Laboratories, and CAPT Hilda Scharen, Director, Medical Device Development Tools Program, Center for Devices and Radiological Health New medical therapies have the ability to change and save lives, and advances in science and technology offer extraordinary opportunities to develop innovative medical products that can lead to better treatments and better care.

But what happens when the accelerating rate of technological advances moves faster than the science for evaluating the benefits and risk of those products? Responding to that challenge is an essential role played by the FDA — helping to ensure that innovation in product development continues, so that patients can get groundbreaking medical products while at the same time ensuring patient safety and that harmful medical devices do not reach the market. [July 11, 2019]

Upcoming Meetings & Workshops

Public Meeting -  Arthritis Advisory Committee Date: Thursday, July 25, 2019 Time: 8:30 AM - 5:00 EDT Agenda: The committee will discuss supplemental new drug application (sNDA) 205832 for nintedanib capsules (drug name OFEV), sponsored by Boehringer Ingelheim, for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). The focus of the discussion will be whether the application provides substantial evidence of efficacy for the proposed indication. Workshop - FDA Public Meeting: Endpoints for Drug Development in Heart Failure Public Workshop Date: Friday, July 26, 2019 Time: 9:00 AM - 4:00 PM EDT Registration: Eventbrite Agenda: The purpose of this public meeting is to bring the stakeholder community together to discuss clinical endpoints for trials in heart failure that could be used to support FDA approval of drugs. The workshop will focus on endpoints related to symptoms and physical function. In addition, there will be discussion of the need to assess mortality effects of drugs under development for heart failure.

The FDA Stakeholder Engagement Staff reside within the Office of the Commissioner and support the FDA mission by engaging with Patient and Health Professional Organizations, Consumer Groups, Trade Associations, Think Tanks and other external stakeholders.  We encourage and support active engagement from external stakeholders related to policy that impacts human and animal medical products, cosmetics, tobacco, nutrition and food safety that promote health and healthy living.