Message from the Associate Commissioner

Dear Women’s Health Colleagues,

July is Fibroid Awareness Month and an opportunity to bring attention to this common medical condition that can cause heavy menstrual bleeding, pelvic pain, and disrupt women’s lives. Unfortunately, many women suffer from fibroids in silence. I invite you to learn about the Agency’s efforts to help improve the lives of women with uterine fibroids in OWH’s July Knowledge and News on Women blog post.  

OWH is now soliciting your feedback to aid in informing our Office’s strategic priorities. The public docket will be open for comments for 60 days. We look forward to receiving your input to ensure that critically important women’s health topics are considered in our science, education, and outreach efforts. 

Sincerely,

Kaveeta P. Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
__________________________________________________________________________

CORONAVIRUS

Below are links to specific COVID-19 topics, with a full list of the latest COVID-19 information from the FDA here.

• FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season
• FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol
• FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines
• Joint Statement from USDA and FDA on Food Export Restrictions Pertaining to COVID-19
• Getting Smarter about Food Safety: The Pandemic and Lessons Learned
• FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts
• FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine
• FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19

CALL TO ACTION

Did you know we launched our new OWH blog during National Women’s Health week in May 2020? July is Fibroid Awareness Month and our feature discussion on the blog. Fibroids are benign non-cancerous muscle tumors of the uterus that can cause heavy menstrual bleeding, pain, bowel or bladder problems and infertility. Learn more about what FDA is doing to address this women’s health issue and how women who lead fibroid awareness organizations are impacted by this condition personally.  

Women's Health Highlights

FDA Posts Interim Results from Required Essure Postmarket Surveillance Study

The FDA posted interim results for the postmarket surveillance ("522") study on Essure, a permanently implanted birth control device for women that, after December 2019, has no longer been available for implantation in the U.S. Sales of Essure in the U.S. were discontinued in December 2018. The FDA continues to recommend that women who have been using Essure successfully to prevent pregnancy can and should continue to do so. Women who suspect the device may be related to symptoms they are experiencing, such as persistent pain, should talk to their doctor about what steps may be appropriate. Device removal has its own risks. Patients should discuss the benefits and risks of any procedure with their health care providers before deciding on the best option for them.
Read the FDA In Brief

FDA Launches New Era of Smarter Food Safety Initiative, Releases Blueprint and Pilot Study

The FDA announced its New Era of Smarter Food Safety Blueprint. We were originally going to make this announcement in March, but as you all are well aware, we were forced to turn our attention to addressing the public health emergency posed by the COVID-19 pandemic. In the months that have followed, it has become even clearer — from our experiences with the pandemic and the lessons we have been learning as part of the FDA’s response to it — just how essential the actions outlined in this blueprint are and, if anything, that they are more important now, than ever. The blueprint outlines a path forward that builds on the work the FDA has already done through implementation of the FDA Food Safety Modernization Act (FSMA).
Read the FDA Statement

FDA Issues Draft Guidance to Encourage Cannabis-Related Clinical Research

The U.S. Food and Drug Administration issued “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry,” which describes the FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds. The draft guidance covers sources of cannabis for clinical research, information on quality considerations and recommendations regarding calculating tetrahydrocannabinol (THC) levels. The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities.
Read the FDA News Release

FDA Approves New HIV Treatment for Patients With Limited Treatment Options

The U.S. Food and Drug Administration approved Rukobia (fostemsavir), a new type of antiretroviral medication for adults living with HIV who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance or safety considerations. 
Read the FDA News Release

FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer

The U.S. Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving chemotherapy.
Read the FDA News Release

FDA Approves Breast Cancer Treatment That Can Be Administered At Home By Health Care Professional

The U.S. Food and Drug Administration approved Phesgo—a combination of pertuzumab, trastuzumab and hyaluronidase–zzxf—for injection under the skin to treat adult patients with HER2-positive breast cancer that has spread to other parts of the body, and for treatment of adult patients with early HER2-positive breast cancer. Patients should be selected based on an FDA-approved companion diagnostic test.
Read the FDA News Release

FDA Advises Consumers Not to Use Hand Sanitizer Products Manufactured by Eskbiochem

FDA is alerting consumers of Saniderm Products and UVT Inc.’s voluntary recall of Saniderm Advanced Hand Sanitizer. Following FDA’s recommendation, two distributors – Saniderm Products and UVT – agreed to recall Saniderm Advanced Hand Sanitizer packaged in 1-liter plastic bottles and labeled with “Made in Mexico” and “Produced by: Eskbiochem SA de CV.”
Read the Company Recall Announcement

Chengdu Ai Qin E-Commerce Co., Ltd Issues Nationwide Recall of TTDEYE Brand Colored Contact Lenses

On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiated a nationwide recall of 1362 pairs of colored contact lenses. The relevant series of contact lenses have been found to be distributed without FDA clearance and may pose a threat to health.
Read the Company Recall Announcement

FDA Announces First of Its Kind Pilot Program to Communicate Patient Reported Outcomes from Cancer Clinical Trials

The U.S. Food and Drug Administration launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). Through a new website, Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments. While this patient-reported data has historically been analyzed by the FDA during the drug approval process, it is rarely included in product labeling and, therefore, is largely inaccessible to the public.
Read the FDA News Release

GSK Consumer Healthcare Issues Voluntary Nationwide Recall of Children's Robitussin® Honey Cough and Chest Congestion DM and Children's Dimetapp® Cold and Cough Due to Dosing Cups Missing Some Graduation Markings

GSK Consumer Healthcare is voluntarily recalling to the retail level two lots of Children's Robitussin® Honey Cough and Chest Congestion DM and one lot of Children's Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups. During the review of the packaging documents for these products, GSK discovered that the dosing cups for the Children's Robitussin® Honey product are missing the 5 mL and 10 mL graduations, while the dosing cups for the Children's Dimetapp® product are missing the 10 mL graduation. The dosing cups packaged with both products only have the 20 mL graduation. There is a potential risk of accidental overdose if caregivers dispensing the syrup do not notice the discrepancies between the graduations printed on the dosing cups and the indicated amounts to be administered (as directed in the instructions for use).
Read the Company Recall Announcement

FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic

The U.S. Food and Drug Administration has issued warning letters to four companies for selling unapproved injectable drug products labeled as homeopathic that can pose serious risks to patient health and violate federal law, as part of the agency’s efforts to protect Americans from potentially harmful products that are labeled as homeopathic.

Additionally, unapproved drugs that claim to cure, treat or prevent serious conditions may cause consumers to delay or stop medical treatments that have been found safe and effective through the FDA review process.
Read the FDA News Release

FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD

The U.S. Food and Drug Administration (FDA) permitted marketing of the first game-based digital therapeutic device to improve attention function in children with attention deficit hyperactivity disorder (ADHD). The prescription-only game-based device, called EndeavorRx, is indicated for pediatric patients ages 8 to12 years old with primarily inattentive or combined-type ADHD who have demonstrated an attention issue.
Read the FDA News Release

FDA Approves Drug to Treat Infants and Children with HIV

The U.S. Food and Drug Administration approved Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for suspension to treat HIV-1 infection in pediatric patients at least four weeks old and weighing at least 3 kg (6.61 pounds) in combination with other antiretroviral treatments.

“For babies and young children with HIV, getting treatment early is very important. HIV can progress more quickly in children than adults,” said Debra Birnkrant, M.D., director of the Division of Antivirals in FDA’s Center for Drug Evaluation and Research. “While the incidence of pediatric HIV infections continues to decline, the availability and early initiation of effective treatment are critical for infants and children living with HIV. Tivicay and Tivicay PD are taken once daily, which could help patients and caregivers better adhere to the regimen. The approval gives our youngest HIV patients more options, helping them live longer, healthier lives.”
Read the FDA News Release

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg Due to the Detection of N-Nitrosodimethylamine (NDMA)

Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg, lot G901203 to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall. Metformin Hydrochloride Extended-Release Tablets USP, 500mg is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. It is packaged in a bottle containing 60 tablets with NDC 68180-336-07.
Read the Company Recall Announcement

Federal Government Announces New Pilot Program to Help Stop Illegal Availability of Unapproved Opioids Online

The U.S. Food and Drug Administration and the National Telecommunications and Information Administration (NTIA) are launching a 120-day pilot to help reduce the availability of unapproved opioids illegally offered for sale online.

Under the pilot, the FDA will notify internet registries that are participating in the pilot – Neustar, Verisign and Public Interest Registry – when the agency sends a warning letter to a website operator and the website operator does not respond adequately within the required timeframe. The internet registries will review the FDA’s notifications and assess whether to take further voluntary action, including possible domain name suspensions or blocks. The NTIA, a branch of the U.S. Department of Commerce, responsible for telecommunications and information policy issues, will work with the internet registries involved in the pilot, and partner with the FDA to assess its impact.
Read the FDA News Release

Meetings

Participate in Upcoming FDA Meetings

The FDA, like other government agencies, is taking the necessary steps to ensure the agency is prepared to continue our vital public health mission in the event that our day-to-day operations are impacted by the COVID-19 public health emergency. Therefore, we are canceling or postponing all non-essential meetings through the month of April. We will reassess on an ongoing basis for future months. Where possible, the agency will leverage technology to host meetings allowing for remote participation. 

Visit FDA Meetings, Conferences and Workshops to find out about available meetings.