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July 2019 Office of Women's Health e-Update

Current Issue: July 2019

three women of different ethnicity, smiling

Message from the Acting Associate Commissioner

Dear Women’s Health Colleagues,

In this month’s e-update newsletter, we are sharing advice from the FDA’s Center for Food Safety and Applied Nutrition informing women who are pregnant, may become pregnant, breastfeeding mothers, and caregivers feeding children 2 years and older about the health benefits of various types of fish. For many women, concerns over mercury in fish limit their fish consumption. FDA’s update includes a chart and a set of frequently asked questions & answers designed to enable informed decision making about which fish to eat and how often, based on mercury levels. 

I invite you to read more about the FDA’s advice on eating fish, and other recent news from the FDA in our Women’s Health Highlights.

Kaveeta Vasisht, M.D., Pharm.D.
Acting Associate Commissioner for Women's Health

Women's Health Highlights

FDA updates 2017 fish advice for pregnant and breastfeeding mothers and young children
FDA and EPA have issued advice regarding eating fish. This advice can help women who are pregnant or may become pregnant - as well as breastfeeding mothers and parents and caregivers feeding children 2 years and older - make informed choices when it comes to fish that are nutritious and safe to eat. This advice supports the recommendations of the 2015-2020 Dietary Guidelines for Americans, developed for people 2 years and older. For advice about feeding children under 2 years of age, you can consult the American Academy of Pediatrics.

The advice features a chart that makes it easier than ever to choose dozens of healthy and safe options and includes information about the nutritional value of fish. A set of frequently asked questions & answers provides more information on how to use the chart and additional tips for eating fish.

FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women  
The U.S. Food and Drug Administration today approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

FDA continues to encourage ongoing education about the benefits and risks associated with PrEP, including additional steps to help reduce the risk of getting HIV
"Since 2012 when the FDA first approved Truvada for a pre-exposure prophylaxis (PrEP) indication, there has been a safe and effective HIV prevention method that, when used along with safer sex practices, can help lower the chances of getting sexually-transmitted HIV,” said Debra Birnkrant, M.D., director of FDA’s Division of Antiviral Products. “We have also reinforced to health care professionals and at-risk individuals that before starting PrEP with Truvada, or emtricitabine/tenofovir disoproxil fumarate, and during its use, health care professionals should routinely screen patients for HIV, at least once every three months. This screening diminishes the risk of individuals with undiagnosed HIV infection developing a resistant strain of HIV while using PrEP. When used according to these guidelines, PrEP can be a powerful HIV prevention tool. When it was first introduced, we took steps to ensure that health care professionals and at-risk individuals understood not only the risks associated with the medication, but also the additional HIV prevention methods they should follow. Now, after seven years, we have evidence showing that the vast majority of health care professionals and at-risk individuals are aware of these risks and prevention methods, and educational materials and treatment guidelines are readily available from the U.S. Centers for Disease Control and Prevention. Therefore, as of today, we are eliminating the risk evaluation and mitigation strategy (REMS) for Truvada and its generics. As a result, the FDA is no longer requiring the drug manufacturers to provide educational materials. We will continue to monitor for risks of these products, as we do for all medicines, and inform the community as appropriate if new risks are identified."

Statement from Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition, on new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry product
Three years ago, the U.S. Food and Drug Administration announced the most comprehensive reform to the Nutrition Facts label since its introduction in 1993. The changes to the label reflect the latest nutritional science available, emphasizing the information that consumers need to make better-informed decisions about their eating habits. In updating the label, we saw a need to acknowledge that Americans are eating differently than two decades ago when the labeling requirements were first introduced, or even in 2006, when we last updated the label with added information about trans fats.  Among other changes, the new label requires that the amount of and percent Daily Value for Added Sugars be declared; the latter of which is based on 50 grams of added sugar per day, or about 12.5 teaspoons, for those consuming 2,000-calories a day. These changes take into account that Americans on average are consuming Added Sugars in amounts that exceed recommended limits. 

FDA approves new treatment for pediatric patients with type 2 diabetes
The U.S. Food and Drug Administration approved Victoza (liraglutide) injection for treatment of pediatric patients 10 years or older with type 2 diabetes. Victoza is the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000. Victoza has been approved to treat adult patients with type 2 diabetes since 2010.

FDA warns patients and health care providers about potential cybersecurity concerns with certain Medtronic insulin pumps
The U.S. Food and Drug Administration is warning patients and health care providers that certain Medtronic MiniMed insulin pumps are being recalled due to potential cybersecurity risks and recommends that patients using these models switch their insulin pump to models that are better equipped to protect against these potential risks. To date, the FDA is not aware of any confirmed reports of patient harm related to these potential cybersecurity risks.

FDA provides draft recommendations to diagnostic manufacturers to help reduce risks of biotin interference with certain lab tests
The U.S. Food and Drug Administration issued a draft guidance: Testing for Biotin Interference in In Vitro Diagnostic Devices. This draft guidance provides recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices.

Biotin, also known as vitamin B7, is a water-soluble vitamin often found in multi-vitamins, prenatal vitamins and dietary supplements marketed for hair, skin and nail growth. As the FDA reported in a safety communication in 2017, the agency is aware of people taking high levels of biotin that may cause interference with lab tests. Many diagnostic tests use biotin technology due to its ability to bind to specific proteins, which can be measured to detect certain health conditions. For example, biotin is used in hormone tests and tests for markers of cardiac health like troponin.

FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses 
The U.S. Food and Drug Administration issued warning letters to two marketers and distributors of kratom products – Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina – for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. The companies also make claims about treating pain, as well as other medical conditions like depression, anxiety and cancer.

FDA’s Center for Tobacco Products Commemorates 10th Anniversary of Tobacco Control Act
When Congress passed the Family Smoking Prevention and Tobacco Control Act (TCA) 10 years ago, it gave FDA new authorities to protect people, particularly youth, from the harms of tobacco use. The law authorized FDA to create its Center for Tobacco Products, with the mission to reduce the death and disease caused by tobacco use. In the decade since the TCA was passed, CTP has established a science-based approach to the regulation of tobacco products; vigorously enforced our authorities to target manufacturers and retailers that violate the law, such as through illegal sales to minors; and designed innovative education campaigns to educate youth on the dangers of tobacco use.

FDA provides free digital calendars to retailers as part of voluntary educational program aimed at preventing illegal sales of e-cigarettes and other tobacco products to minors
The U.S. Food and Drug Administration announced today that a new digital age verification calendar is available as part of the agency’s “This is Our Watch” voluntary retailer education program, which is designed to prevent and reduce sales of e-cigarettes and other tobacco products to minors. As part of this voluntary program, the digital calendar, which makes it easier to verify a consumer’s age, is being mailed to retailers across the U.S this month and will also be available to order for free to retailers from the Center for Tobacco Products Exchange Lab. Retailers can digitally set the minimum age on the calendar, as appropriate for their location.

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs
The U.S. Food and Drug Administration is committed to helping facilitate American patients’ access to lower-cost generic medicines by taking steps to enhance and streamline the development and approval process of high-quality generic drugs. The U.S. already has one of the most effective and efficient generic markets in the world. Generic drugs represented 90% of U.S. prescriptions dispensed in 2017, and the FDA approved or tentatively approved more than 2,000 generic drug applications in 2017 and 2018 alone. But, there is more we may be able to do to facilitate a stable, competitive market.

Plan, Prepare and Protect Your Pet Before, During and After an Emergency
When it comes to planning for emergencies, pet owners should consider their pets too. With some simple preparations now, you can make sure your pet will be protected, safe and healthy, during and after any emergency. In the middle of a disaster, or when you know one is imminent, you may not be able to prepare for the specific needs of your pet.

Call To Action 

Women’s Health Resources

Our Heart Health toolkit is now available en Espanol! The FDA Office of Women's Health offers resources to help women and healthcare providers get informed about heart health. The Heart Health Social Media Toolkit can be used to encourage women in your network to protect their hearts. The toolkit includes resources for 'everyday' women and health professionals, including sample social media messages and blog posts.


Participate in Upcoming FDA Meetings

Overview of FDA’s Perinatal Health Center of Excellence: Development and Validation of Predictive Systems – Webcast Lecture
July 11, 2019

FDA Public Meeting: Limited Population Pathway for Antibacterial and Antifungal Drugs
July 12, 2019; Silver Spring, MD

Perspectives on In Vitro Diagnostic Devices Regulated by the Office of Blood Research and Review; Public Workshop
July 15-16, 2019; Silver Spring, MD

Public Workshop: Biomarkers of Neurotoxicity
July 23, 2019; Silver Spring, MD

Arthritis Advisory Committee Meeting Announcement
July 25, 2019; Silver Spring, MD

FDA Public Meeting: Endpoints for Drug Development in Heart Failure
July 26, 2019; Silver Spring, MD

FDA Public Workshop: Topical Drug Development - Evolution of Science and Regulatory Policy
July 29-30, 2019; Baltimore, MD

Psychopharmacologic Drugs Advisory Committee Meeting Announcement
July 31, 2019; Silver Spring, MD

Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real-World Setting Meeting Information
August 12, 2019; Silver Spring, MD

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