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December 2019 Office of Women's Health e-Update

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Message from the Acting Associate Commissioner

Dear Women’s Health Colleagues,

As 2019 comes to an end, we are reflecting on the breadth of this year’s activities and our opportunities to build on these successes.

In 2019, we funded women’s health research, published research, and presented and exhibited at national and international conferences. We convened our Scientific Speaker Series, which included educational seminars on topics ranging from gender bias in artificial intelligence to sex differences in space exploration and menopause. Our Office also worked to advance knowledge on the safety of medications in pregnant and lactating women.  

With your support, we will continue to promote and protect the health of women through our partnerships within the Agency and with our stakeholders.  

We hope you have a happy, healthy holiday season and look forward to connecting with you in the New Year.

Sincerely,

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

Women's Health Highlights

FDA authorizes first test to aid in newborn screening for Duchenne Muscular Dystrophy
The U.S. Food and Drug Administration authorized marketing of the first test to aid in newborn screening for Duchenne Muscular Dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness.

“Diagnostics that can safely and effectively screen newborns can help health care professionals identify and discuss potential treatment options with parents and caregivers before symptoms or effects on a baby’s health may be noticeable,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “This authorization reflects our commitment to fostering innovation in devices to help inform and provide options to patients and their caregivers. Early screening can help identify individuals who need additional follow up or treatment.”

Now’s still a good time to get your flu vaccine
Haven’t had your flu vaccine yet? It’s not too late. And there are still good reasons to get one. Flu — more formally known as influenza — is a serious viral disease that can lead to hospitalization and even death. Every flu season is different, and the substantial health impacts can vary widely from season to season. Your best defense is vaccination, which provides important protection from influenza illness and its potential complications.

Consumers should not use drugs, dietary supplements and devices recalled from Basic Reset and Biogenyx following consent decree for federal violations
The U.S. Food and Drug Administration is alerting consumers of a recall of 25 drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx of Hendersonville, Tennessee. In September, a federal court entered a consent decree of permanent injunction between the United States and the two companies and their owner, Fred R. Kaufman III. Under the consent decree, Basic Reset and Biogenyx must recall and stop distributing products until the companies comply with the Federal Food, Drug, and Cosmetic Act and other requirements listed in the consent decree.

FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk
The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, of Yorba Linda, California, and their presidents and chief executive officers, Roya Panah and John W. Kosolcharoen, for processing and distributing unapproved products derived from umbilical cord blood. They have also been warned regarding significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including deficient donor eligibility practices, inadequate aseptic practices to prevent contamination and deficient environmental monitoring. These deviations create potential significant safety concerns that put patients at risk. The companies’ unapproved products derived from umbilical cord blood are PURE and PURE PRO.

Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the U.S.
The U.S. Food and Drug Administration has been investigating the presence of genotoxic impurities, called nitrosamines, in some types of drugs. Over the past year and a half, several drug products including angiotensin II receptor blockers (ARBs) and ranitidine, commonly known as Zantac, have been found to contain small amounts of nitrosamines such as N-Nitrosodimethylamine (NDMA). During this time, there has been an ongoing investigation into the presence of nitrosamines in other drug products. This effort is focused on ensuring the drugs used by Americans continue to meet strict quality standards.

The FDA is aware that some metformin diabetes medicines in other countries were reported to have low levels of NDMA. Based on the information we have available, the levels of NDMA seen outside the U.S. are within the range that is naturally occurring in some foods and in water. While we are aware that some regulatory agencies outside the U.S. may be recalling some metformin drugs, there are no metformin recalls affecting the U.S. market at this time.

FDA approves first generics of Gilenya
The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.

“Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Having access to affordable treatments is important for patients with conditions that require ongoing care. The FDA has a longstanding commitment to increasing patient access to lower-cost, high-quality generic medicines.”

FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases
FDA announced the global launch of CURE ID, an internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a website, a smartphone or other mobile device. The platform enables the crowdsourcing of medical information from health care providers to guide potentially life-saving interventions and facilitate the development of new drugs for neglected diseases. The repository is a collaboration between the FDA and the National Center for Advancing Translational Sciences (NCATS), which is part of the National Institutes of Health (NIH).

FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health
The U.S. Food and Drug Administration ordered Gynecology, Reproductive Endocrinology and Fertility Institute of San Juan, Puerto Rico and its Medical Director and Owner, Dr. Rosa I. Cruz, to immediately cease manufacturing due to significant violations of FDA regulations. An FDA inspection and subsequent record review revealed significant violations of regulations regarding donor eligibility determinations, including donor screening and testing. The clinic’s failure to fulfill these requirements puts patients at risk for exposure to communicable diseases, including HIV and hepatitis.

Call To Action

women wearing black shirts w red ribbons

December is AIDS/HIV Awareness Month! Every year, thousands of women are infected with HIV. The Office of Women’s Health wants to raise awareness and highlight our updated information on FDA-approved medicines to treat HIV. Share our resources to prevent and treat HIV with the women in your family and community today!

Meetings

Participate in Upcoming FDA Meetings

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee
January 14-15, 2020

Anesthetic and Analgesic Drug Products Advisory Committee Meeting
January 16, 2020

Public Workshop - Evolving Role of Artificial Intelligence in Radiological Imaging
February 25-26, 2020

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