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March 2020 Office of Women's Health e-Update

illustration of hands holding signs reading "Women's History Month"

Message from the Associate Commissioner

Dear Women’s Health Colleagues,

As we recognize Women’s History Month and the important contributions women continue to make to society, our office is proud to lead efforts that highlight the importance of considering sex differences in regulatory science. Last month, we kicked off our 2020 Scientific Speaker Series by welcoming Dr. Sabra Klein, Associate Professor of Molecular Microbiology and Immunology at Johns Hopkins Bloomberg School of Public Health. Dr. Klein discussed the importance of sex as a biological variable in immune function and its impact on vaccines.

I am pleased to share that FDA recently released the 2019 Drug Trials Snapshots Report. This report summarizes demographic groups represented in the clinical trials for 48 novel drugs approved in 2019. Overall, 46,391 patients participated in these trials and 72 percent were women, reflecting the approval of drugs for women affected by conditions including breast cancer, post-menopausal osteoporosis, postpartum depression, and hypoactive sexual desire disorder. In addition, there were novel drugs approved for diseases that have a high prevalence in women, such as rheumatoid arthritis, migraine, irritable bowel syndrome, multiple sclerosis, and iron deficiency anemia. 

In this month’s newsletter, you will also learn about FDA’s actions to increase the safety of laparoscopic power morcellators when used in gynecologic surgeries, our recent request for the voluntary withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin), and much more.

Thank you for your continued support as we work together to help women live healthier lives.


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


collage photo image of young women posing

Every year, thousands of women are infected with HIV. Annual awareness days help to educate the general public and specific communities about HIV/AIDS. This month, we recognize National Women & Girls HIV/AIDS Day (March 10) and National Native HIV/AIDS Awareness Day (March 20). It’s an opportunity for people across the United States to learn more about HIV/AIDS prevention, treatment and the need for HIV testing. The FDA Office of Women’s Health provides resources on women and HIV and FDA-approved medicines to help the women in your family and community learn how to prevent and treat HIV. 


Coronavirus (COVID-19) Update: FDA and CDC take action to increase access to respirators, including N95s, for health care personnel
In a joint effort, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention took action to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings. This action allows certain National Institute for Occupational Safety and Health (NIOSH) approved respirators not currently regulated by the FDA to be used in a health care setting by health care personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system
•    Read the FDA News Release

FDA Takes New Steps to Increase the Safety of Laparoscopic Power Morcellators when used in Gynecologic Surgeries
FDA is taking several important steps to make the use of laparoscopic power morcellators (LPMs) safer in gynecologic surgeries, including granting marketing authorization for updated labeling of the PneumoLiner containment system (a device that contains tissue to be morcellated during certain gynecologic surgeries), releasing a draft guidance recommending the addition of specific safety information to the product labeling for LPMs, and issuing a Safety Communication recommending that an LPM only be used in certain gynecologic surgeries with a containment system that is compatible with the LPM. 
•    Read the FDA News Release

FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market
The U.S. Food and Drug Administration (FDA) requested that the manufacturer of Belviq, Belviq XR (lorcaserin) voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. The drug manufacturer, Eisai Inc., has submitted a request to voluntarily withdraw the drug.
•    Learn More

FDA Authorizes Marketing of the First Genetic Test to Aid in the Diagnosis of Fragile X Syndrome
The U.S. Food and Drug Administration authorized marketing of the first test to detect a genetic condition known as Fragile X Syndrome (FXS), the most common known cause of inherited developmental delay and intellectual disability. The test is intended as an aid in diagnosing FXS and is to be used along with the evaluation of a patient’s family history and clinical signs and symptoms of FXS. Additionally, this test is intended for use in adults who may be carriers of genetic alterations in the gene associated with FXS, called the FMR1 gene.
•    Read the FDA News Release

FDA Launches “Feed Your Mind” to Help Consumers Better Understand the Science Behind Foods Derived from Genetic Engineering
The U.S. Food and Drug Administration (FDA) launched a new education initiative called “Feed Your Mind” to help consumers better understand genetically engineered foods, commonly called GMOs or genetically modified organisms. The initiative was developed with the U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA) to provide consumers with science-based educational information to better understand how GMOs are made, learn more about the types of crops that have been modified, address questions they may have about the health and safety of GMOs as well as explain how GMOs are regulated in the U.S.

FDA Announces Collaborative Review of Scientific Evidence to Support Associations Between Genetic Information and Specific Medications
Pharmacogenetic testing is a type of genetic test that in some instances can predict how a person will respond to specific medications. Thus, this type of testing offers promise for informing the selection or dosing of some medications for certain individuals. The U.S. Food and Drug Administration (FDA) introduced a collaboration between the FDA’s Center for Devices and Radiological Health and Center for Drug Evaluation and Research intended to provide the agency’s view of the state of the current science in pharmacogenetics. 
•    Read the FDA News Statement

FDA Works to Ensure Smooth Regulatory Transition of Insulin and Other Biological Products
The U.S. Food and Drug Administration (FDA) took additional steps to ensure a smooth regulatory transition aimed at increasing patient access to insulin products used daily by millions of Americans to maintain stable blood glucose levels, as well as certain other biological products set to transition regulatory pathways in March. FDA actions include publishing a final rule and additional resources to provide useful information to stakeholders, including industry, patients and health care providers.
•    Read FDA News Release

FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process
The U.S. Food and Drug Administration approved three drugs for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for the temporary relief of arthritis pain;  Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1%) for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair or dander; and Pataday Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2%) for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander, for nonprescription use.
•    Read the FDA News Release

FDA Authorizes Marketing of First Cardiac Ultrasound Software That Uses Artificial Intelligence to Guide User
The U.S. Food and Drug Administration authorized marketing of software to assist medical professionals in the acquisition of cardiac ultrasound, or echocardiography, images. The software, called Caption Guidance, is an accessory to compatible diagnostic ultrasound systems and uses artificial intelligence to help the user capture images of a patient’s heart that are of acceptable diagnostic quality. The Caption Guidance software is indicated for use in ultrasound examination of the heart, known as two-dimensional transthoracic echocardiography (2D-TTE), for adult patients, specifically in the acquisition of standard views of the heart from different angles. These views are typically used in the diagnosis of various cardiac conditions.
•    Read the FDA News Release

FDA 2019 Drug Trials Snapshots Summary Report
The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released a report titled “2019 Drug Trials Snapshots Summary Report.” The report summarizes CDER’s 2019 Drug Trials Snapshots program, highlighting the 48 novel drug approvals of 2019, by illustrating the demographic groups represented in the clinical trials for these novel drugs.
•    Learn More

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5ml Due to Possible Underdosing or Overdosing 
Taro Pharmaceuticals U.S.A., Inc. is voluntarily recalling two (2) lots of Phenytoin Oral Suspension USP, 125 mg/5 mL both in 237 mL bottles, to the consumer level. Phenytoin Oral Suspension USP, 125 mg/5 mL is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and is packaged in amber plastic bottles with an inner seal and a white child proof closure, and each bottle contains 237 mL. The reason for the recall is that product from these two lots of Phenytoin Oral Suspension may not re-suspend when shaken, as instructed for administration, which could result in under or overdosing. This recall is being conducted with the knowledge of the FDA. The population at risk is primarily infants and young children. 
•    Learn More


Patient-Focused Drug Development for Stimulant Use Disorder
March 10, 2020

Public Meeting on Patient-Focused Drug Development for Vitiligo
March 30, 2020

Public Meeting - Food and Drug Administration’s Communications About the Safety of Medical Devices
April 1, 2020

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

Visit the OWH exhibit booth at these upcoming conferences.

  • Society for Public Health Education (SOPHE) 2020 Annual Conference; March 17-20, Atlanta, GA)
  • American Pharmacists Association Annual Meeting (APhA); March 20-23, Washington, DC)
  • Aging in America Conference; March 24-27, Atlanta, GA 


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