June 2022 Office of Women's Health e-Update
Message from the Associate Commissioner
Dear Colleagues,
Maternal health is a critically important focus area for OWH. I am pleased to share that last month we hosted an informative virtual public workshop focused on Leveraging Real-World Data to Study Medication Use in Pregnancy and Lactation. Developed in collaboration with the Johns Hopkins Center of Excellence in Regulatory Science and Innovation, the workshop focused on the potential role of real-world data to help address gaps in our knowledge on medication use in pregnancy and lactation. Participants also discussed opportunities and challenges of collecting real-world data, and current regulatory perspectives on the collection and potential use of real-world data and real-world evidence. I encourage you to view the workshop here.
In addition, we developed an educational webinar in collaboration with CDER’s Division of Pediatrics and Maternal Health. This webinar examined how our current prescription drug labeling system can be used to inform prescribing medications in pregnancy and lactation. I invite you to watch the Pregnancy and Lactation Medication Information for the Healthcare Provider webinar here.
Please share the resources we featured during National Women’s Health Week (NWHW) with your networks.
Sincerely,
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
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.
- Know Your Treatment Options for COVID-19 Consumer Update
- FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years
- FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV
- FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals
CALL TO ACTION
National HIV Testing Day is an annual observance celebrated on June 27 to encourage people to get tested for HIV, know their status and get access to care and treatment. Every year, thousands of women are infected with HIV. Knowing your HIV status helps you make decisions to prevent getting or transmitting HIV. Learn the facts and teach the women in your family and community how to prevent and treat HIV here.
INFANT FORMULA UPDATES
For the latest on infant formula, please visit the FDA webpage, Infant Formula Information and Ongoing FDA Efforts to Increase Supply and the HHS webpage, Information for Families During the Formula Shortage.
WOMEN'S HEALTH HIGHLIGHTS
FDA Approves First Systemic Treatment for Alopecia Areata
The U.S. Food and Drug Administration approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the U.S. each year. This action marks the first FDA approval of a systemic treatment (i.e. treats the entire body rather than a specific location) for alopecia areata.
Products Marketed for Removing Moles and Other Skin Lesions Can Cause Injuries, Scarring
As we get older, we can develop new growths on our skin that we may consider unattractive. These lesions are parts of the skin that look abnormal and include moles, seborrheic keratoses (wart-like growths), and skin tags. Removing them isn’t a do-it-yourself project, and it can be dangerous to try. Please see a healthcare provider to have them evaluated and removed, if necessary.
Currently, there are no U.S. Food and Drug Administration approved prescription or over-the-counter (OTC) drugs for treating moles, seborrheic keratoses, or skin tags.
FDA Launches Campaign Aimed at Preventing E-Cigarette Use Among American Indian/Alaska Native Youth
The U.S. Food and Drug Administration announced the launch of the “Next Legends” Youth E-cigarette Prevention Campaign as part of the agency’s ongoing efforts to protect youth from the dangers of tobacco use. The campaign will educate American Indian/Alaska Native (AI/AN) youth, ages 12-17, about the harms of vaping through unique branding and tailored messaging created to inspire a new generation to live Native strong and vape-free.
FDA Launches New Dietary Supplement Education Initiative for Consumers, Educators, and Healthcare Professionals
The U.S. Food and Drug Administration launched a new initiative, Supplement Your Knowledge, to help educate, inform, and broaden consumer, educator and healthcare professional understanding of dietary supplements. More than half of all Americans take dietary supplements daily or on occasion. Today’s Supplement Your Knowledge resources will provide reliable information about the potential benefits and risks associated with dietary supplements, such as vitamins, minerals, and herbs, they may consume.
Outbreak Investigation of Salmonella: Peanut Butter (May 2022)
J.M. Smucker Company has voluntarily recalled certain Jif brand peanut butter products that have the lot code numbers between 1274425 – 2140425, only if the first seven digits end with 425 (manufactured in Lexington, KY). The FDA, along with CDC and state and local partners, are investigating a multistate outbreak of Salmonella Senftenberg infections linked to certain Jif peanut butter products produced at the J.M. FDA’s investigation is ongoing, and more information will be provided as it becomes available.
Updates on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls
The U.S. Food and Drug Administration (FDA) updated its safety communications and frequently asked questions about the Philips Respironics ventilator, BiPAP machine, and CPAP machine recalls on FDA.gov to provide the latest information about medical device reports associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam.
New FDA Draft Guidance Aims to Increase Safety Information About Dietary Supplement Marketplace
The U.S. Food and Drug Administration announced the availability of a draft guidance aimed at increasing the amount of safety information the agency has about the dietary supplement marketplace by providing the industry an opportunity to submit late new dietary ingredient (NDI) notifications.
The FDA wants consumers who use dietary supplements to know that today’s draft guidance, if finalized, will advise the dietary supplement industry that the agency intends to exercise enforcement discretion, for a limited time and in limited circumstances, to encourage manufacturers and distributors to correct any past failures to submit a required NDI notification. By providing industry with an opportunity to correct past failures to submit required safety information, the FDA can gain more safety information about the dietary supplement marketplace and better protect public health.
FDA Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability
On May 16, the U.S. Food and Drug Administration announced a guidance that outlines increased flexibilities regarding importation of certain infant formula products to further increase the availability of infant formula across the country while protecting the health of infants. The agency is encouraging infant formula manufacturers worldwide to take advantage of these flexibilities.
FDA Provides New Updates on Activities to Mitigate Infant Formula Supply Challenges, Abbott Nutrition Agrees to Take Corrective Actions at Facility to Produce Safe Infant Formula
On May 16, the U.S. Food and Drug Administration announced important updates on its ongoing work to increase the supply and availability of infant formula in the U.S. On Feb. 17, the agency warned consumers not to use certain powdered infant formula products from Abbott Nutrition’s Sturgis, Michigan infant formula production facility, and Abbott voluntarily ceased production at this facility as well as initiated a voluntary recall of certain products.
A proposed consent decree of permanent injunction between the FDA and Abbott Nutrition, as well as three Abbott principals, was filed in the U.S. District Court for the Western District of Michigan. Under the proposed consent decree, which is subject to court approval and entry, Abbott has agreed to take corrective actions following an FDA inspection of its Sturgis, Michigan facility.
FDA Approves Novel, Dual-Targeted Treatment for Type 2 Diabetes
The U.S. Food and Drug Administration approved Mounjaro (tirzepatide) injection to improve blood sugar control in adults with type 2 diabetes, as an addition to diet and exercise. Mounjaro was effective at improving blood sugar and was more effective than the other diabetes therapies with which it was compared in clinical studies.
FDA Warns Consumers About the Accidental Ingestion by Children of Food Products Containing THC
Risk of accidental ingestion, especially by children, of edible products that contain THC. Some manufacturers package & label these products to look like cereal, candy, and cookies that appeal to children & easily mistaken for popular foods. The FDA is aware of reports of copycat products packaged to look like Cap’n Crunch, Cocoa Pebbles, Cocoa Puffs, Froot Loops, Fruity Pebbles, Nerds Ropes, Starbursts, Sour Patch Kids, and Trix, among others.
Caution: Bodybuilding Products Can Be Risky
The U.S. Food and Drug Administration (FDA) found some bodybuilding products may illegally contain steroids or steroid-like substances associated with potentially serious health risks, including liver injury, which can be life-threatening. The FDA has received hundreds of adverse event reports, including those showing evidence of serious liver injury.
Is It Really ‘FDA Approved’?
Maybe you saw those words on a company’s website or in a commercial promoting a product or treatment. Some marketers may say their products are “FDA approved.” But how can you know for sure what the U.S. Food and Drug Administration has approved?
Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care - Letter to Health Care Providers
The U.S. Food and Drug Administration is issuing a Letter to Health Care Providers to share information about the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) with the following hemodialysis machines manufactured by Fresenius Medical Care: the 2008T, 2008K2, and 2008K models. The 2008K2 and 2008K models are no longer manufactured but may still be in clinical use.
The source of the NDL PCBAs and NDL PCBs is from the silicone tubing used as a part of the hydraulics in the machine and the dialysate lines. Although the tubing for the dialysate lines does not directly contact the blood, there is the potential for back filtering through the dialyzer into the patient’s blood circulation during treatment.
FDA Grants Regular Approval to Fam-trastuzumab Deruxtecan-nxki for Breast Cancer
On May 4, 2022, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy.
FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease
The U.S. Food and Drug Administration today permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease. The Lumipulse G β-Amyloid Ratio (1-42/1-40) test is intended to be used in adult patients, aged 55 years and older, presenting with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.
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
- Conversations on Cancer: "National Black Family Cancer Awareness Week: Engaging the Generations”, June 16, 2022
- Vaccines and Related Biological Products Advisory Committee Meeting, June 28, 2022
- FDA Workshop: 7th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop, June 29, 2022
- FDA Patient Engagement Advisory Committee Meeting: Augmented Reality (AR) and Virtual Reality (VR) Medical Devices, July 12-13, 2022
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.