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June 2018 Office of Women's Health e-Update

The Great Debate: Dr. Ellis Unger and Dr. Rita Redberg

Message from the Director

Dear Women’s Health Colleagues,

As you know, FDA makes review decisions looking at a variety of factors. Key among them -- Sex as a Biological Variable (SABV). It is important that drug approvals ensure safety and efficacy for the populations most likely to utilize the products. It is data that support our approval decisions, with the percentages of women vs men included in the clinical trial one of many considerations. We have been quoted as saying – “we need enough” data to make the regulatory decision. So the Great Debate explored the question – “What is Enough?” – to ensure safe and effective cardiovascular medications for both women and men.

When it comes to data, FDA’s is not just focused on clinical trial participation. Our goal is to be able to make a reasonable assessment of trial results in order to ensure efficacy and safety for the public.

We perform our work in a regulatory framework and approaches to and sources of data which inform our decisions are diverse and varied. Our primary data source is in the drug application; however additional sources may be used to inform our decisions at all phases of the pre-market and post-market processes. FDA’s data analysis and approach is broader than the conventional academic model. This must be the case given the complexity of public health decision-making, drug law and balancing risks vs. benefits.

I will close by saying that even in the heat of debate, FDA must remain committed to sharing what we know and do not know with others including scientists, clinicians, patients and consumers to get the best possible products – to the people who need them – fast!
Thank you, Dr. Redberg and Dr. Unger for your thoughtful presentations, and to our own Director of Medical Initiatives and Scientific Engagement, Dr. Marjorie Jenkins, for moderating this event. In addition, let’s all congratulate Dr. Jenkins for receiving the “Linda Joy Pollin Women’s Heart Health Leadership Award” from the Barbra Streisand Women’s Heart Center and the “Award for Public Policy & Advocacy in Women's Health" from the Women's Health Congress 2018 Conference.  

Marsha Henderson, Associate Commissioner for Women's Health

Women's Health Highlights

The Great Debate: What is Enough … Women in Clinical Trials Recap

View videos and resources from The Great Debate: What is Enough … Women in Clinical Trials here:

FDA launches innovation challenge to spur development of medical devices that target pain, addiction and diversion
The U.S. Food and Drug Administration launched an innovation challenge to spur the development of medical devices, including digital health technologies and diagnostic tests that could provide novel solutions to detecting, treating and preventing addiction, addressing diversion and treating pain. This is just one part of the Agency’s ongoing commitment to address the scourge of opioid misuse and abuse.

FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults
FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days. Lucemyra is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD.
“As part of our commitment to support patients struggling with addiction, we’re dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue opioids,” said FDA Commissioner Scott Gottlieb, M.D.

FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, and lack of benefit
FDA is warning consumers that over-the-counter (OTC) teething products containing benzocaine pose a serious risk to infants and children. The agency announced that OTC oral health products containing the pain reliever benzocaine for the temporary relief of sore gums due to teething in infants or children should no longer be marketed and is asking companies to stop selling these products for such use. 


Participate in Upcoming FDA Meetings

FDA Public Workshop: FDA-AACR-SGO Workshop on Drug Development in Gynecologic Malignancies
June 14, 2018, 8:00 am to 5:00 pm
FDA White Oak Campus, Silver Spring, MD
Public Workshop: 2018 Clinical Outcome Assessments in Cancer Clinical Trials
June 22, 2018, 8:15 am to 5:00 pm
FDA White Oak Campus, Silver Spring, MD
2018 Center for Biologics Evaluation and Research Science Symposium
June 25 – 26, 2018, 9:00 am to 3:00 pm
FDA White Oak Campus, Silver Spring, MD

Learn more about OWH staff presentations at national and international meetings and conferences

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