July 2022 Office of Women's Health e-Update
Message from the Associate Commissioner
Dear Colleagues,
Each July, OWH aims to educate and raise awareness about uterine fibroids in recognition of Fibroid Awareness Month. Uterine fibroids are the most common benign (not cancerous) tumors in women of childbearing age. Fibroids grow in and around the wall of the uterus and symptoms can include heavy menstrual bleeding, pain, bowel and/or bladder problems and infertility. OWH is dedicated to empowering women living with uterine fibroids. This year, we partnered with The White Dress Project to develop new educational content on this critical women’s health condition. View our informational video to learn more about fibroid symptoms, risk factors and management options. I also encourage you to read our July OWH blog, which shares La-Anna Douglas’s powerful personal journey living with uterine fibroids.
To further support our commitment, I am pleased to share our new uterine fibroid webpage and fact sheet with you. We hope you find these resources to be a valuable source of information for yourself and your communities.
Sincerely,
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
INFANT FORMULA UPDATES
- FDA Developing New Framework for Continued, Expanded Access to Infant Formula Options for U.S. Parents and Caregivers
- Infant Formula Information and Ongoing FDA Efforts to Increase Supply
- Infant Formula Supply
CORONAVIRUS UPDATES
Below are links to specific COVID-19 topics and the latest vaccine fact sheets, with a full list of the latest COVID-19 information from the FDA here.
- FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations
- FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses
- FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age
CALL TO ACTION
July is UV Safety Month. Sun exposure can cause sunburn, skin aging (such as skin spots, wrinkles, or “leathery skin”), eye damage, and skin cancer, the most common of all cancers. Remember to limit your time in the sun, wear clothing to cover exposed skin from the sun and use broad spectrum sunscreen with SPF values of 15 or higher. Learn more on how to protect your skin from the sun here.
WOMEN'S HEALTH HIGHLIGHTS
Do Not Use Baby Neck Floats
The U.S. Food and Drug Administration (FDA) is warning parents, caregivers, and health care providers not to use neck floats with babies for water therapy intervention, especially with babies who have developmental delays or special needs, such as spina bifida, spinal muscular atrophy (SMA) type 1, Down syndrome, or cerebral palsy. The use of these products can lead to death or serious injury.
Generic Drugs Undergo Rigorous FDA Review
The FDA approval process ensures that medicines are safe and effective. FDA-approved generic drugs, like their brand counterparts, have met strict approval standards. Today, about 9 in 10 prescriptions filled in the U.S. are for generic drugs.
FDA Introduces Innovative Proposal to Advance Consumer Access to Nonprescription Drugs
The U.S. Food and Drug Administration issued a proposed rule titled, “Nonprescription Drug Product with an Additional Condition for Nonprescription Use,” which is intended to broaden the range of marketed nonprescription drugs available to consumers, empowering them to self-treat certain common conditions and improving public health.
FDA approves treatment for chronic weight management in pediatric patients aged 12 years and older
The U.S. Food and Drug Administration has approved a supplemental indication for Qsymia (phentermine and topiramate extended-release capsules) for chronic weight management in pediatric patients aged 12 years and older who are obese, defined as a body mass index (BMI) of 95th percentile or greater when standardized for age and sex. Qsymia should be used as additional therapy to reduced-calorie diet and increased physical activity.
FDA approves treatment for weight management in patients with Bardet-Biedl Syndrome aged 6 or older
The U.S. Food and Drug Administration has approved a supplemental indication for Imcivree (setmelanotide) injection for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to Bardet-Biedl Syndrome (BBS). Imcivree is the first drug approved specifically for chronic weight management in patients with BBS, a rare genetic disorder associated with early-onset childhood obesity.
FDA Releases Action Plan for Rare Neurodegenerative Diseases, Including ALS
The U.S. Food and Drug Administration unveiled its Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) – a five-year strategy for improving and extending the lives of people living with rare neurodegenerative diseases by advancing the development of safe and effective medical products and facilitating patient access to novel treatments.
FDA Denies Authorization to Market JUUL Products
The U.S. Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action. The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%.
Retailers should contact JUUL with any questions about products in their inventory.
FDA Announces Plans for Proposed Rule to Reduce Addictiveness of Cigarettes and Other Combusted Tobacco Products
The Biden-Harris Administration published plans for future potential regulatory actions that include the U.S. Food and Drug Administration’s plans to develop a proposed product standard that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products. The goal of the potential rule would be to reduce youth use, addiction, and death.
Pregnancy Registry
Pregnancy exposure registries are studies that collect health information on exposure to medical products such as drugs and vaccines during pregnancy.
Learn more about pregnancy registries today!
Participate in Upcoming FDA Meetings
- General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement, July 28-29, 2022
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.