August 2020 Office of Women's Health e-Update

Message from the Associate Commissioner

Dear Women’s Health Colleagues,

The Office of Women’s Health (OWH) strives to enhance the regulatory process and advance the health of women through science, outreach, and education. This month, in recognition of National Breastfeeding Month, we are highlighting our educational resources and recent activities related to maternal health.

We kicked off the month by hosting our first fully virtual seminar and welcomed Dr. Vincenzo Berghella, Director of the Maternal-Fetal Medicine Division at Thomas Jefferson University, as our featured speaker for our OWH Scientific Seminar Series. Dr. Berghella gave an informative lecture and shared his insights on COVID-19 and pregnancy with FDA staff.

I am also pleased to inform you that FDA issued a draft guidance last month to assist applicants in complying with the content and format requirements for the Pregnancy, Lactation, and Females and Males Reproductive Potential subsections of the label for human prescription drugs and biological products. The FDA product label serves as a critical resource for healthcare providers and consumers. I encourage you to read this draft guidance and submit your comments and suggestions. I also invite you to learn about FDA’s educational resources for nursing mothers in the Call to Action section below.

As mentioned in last month’s newsletter, OWH is soliciting input to help inform our strategic priorities. The Federal Register public docket will be open for comments until September 8, 2020. We look forward to receiving your feedback.

Sincerely,

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

CORONAVIRUS

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

CALL TO ACTION

In case you missed it, we highlighted breast pump basics and breastfeeding drug safety tips earlier this month in recognition of National Breastfeeding Month and specifically, World Breastfeeding Week! We encourage you to share these resources with the new and expectant moms in your life and communities. Visit www.fda.gov/womens for additional resources on pregnancy and becoming a new mom.

This month also marks the beginning of back-to-school season, which looks different for many given the COVID-19 pandemic. However, we have resources to help students, parents, and/ or health care professionals navigate this new normal.

Download and share our College Women’s Campaign resources
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WOMEN'S HEALTH HIGHLIGHTS

FDA Finalizes Rule Related to Gluten-Free Labeling for Foods Containing Fermented, Hydrolyzed Ingredients

The U.S. Food and Drug Administration issued a final rule to establish compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and that bear the “gluten-free” claim. The rule pertains to foods such as soy sauce, yogurt, sauerkraut, pickles, cheese and green olives. Distilled foods, such as distilled vinegars, are also included in the final rule. “These new compliance requirements for labeling a product ‘gluten-free’ will protect individuals with celiac disease, an incurable, hereditary disorder that millions of Americans, including myself, live with,” said HHS Secretary Alex Azar.

Read FDA News Release

FDA Posts Additional Postmarket Information for Essure

FDA posted the first spreadsheet of reportable events received from Bayer following granting of an adverse event reporting variance in April 2020. FDA continues to take concerns about Essure very seriously and is committed to postmarket evaluation.
Read FDA In Brief

FDA Takes Action to Limit Inorganic Arsenic Levels in Infant Rice Cereal

The U.S. Food and Drug Administration issued guidance finalizing the 2016 draft guidance for inorganic arsenic in infant rice cereals and identifying the agency’s intended sampling and enforcement approach. The guidance identifies an action level of 100 micrograms per kilogram (µg/kg) or 100 parts per billion (ppb) which protects public health by reducing infants’ dietary exposure to inorganic arsenic and is achievable by industry. FDA testing of infant rice cereals over the last decade suggests that manufacturers are already making significant progress in reaching this action level through good manufacturing practices, such as selective sourcing and testing of rice and rice-derived ingredients (e.g., rice flour) to ensure lower levels of inorganic arsenic.
Read FDA In Brief

FDA Warns Companies Illegally Selling Hangover Remedies

The U.S. Food and Drug Administration announced it has issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate or prevent hangovers, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters were issued to: Double Wood LLC; Ebnsol Inc.; Vita Heaven LLC (doing business as Hangover Heaven); Happy Hour Vitamins; LES Labs; Mind, Body & Coal LLC; and Purple Biosciences LLC.
Read FDA News Release

FDA Requiring Labeling Changes for Opioid Pain Medicines, Opioid Use Disorder Medicines Regarding Naloxone - Goal is to Help Reduce Opioid Overdoses and Deaths

The U.S. Food and Drug Administration announced it is requiring that labeling for opioid pain medicine and medicine to treat opioid use disorder (OUD) be updated to recommend that as a routine part of prescribing these medicines, health care professionals should discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment. Naloxone is a medicine that can be administered by individuals with or without medical training to help reduce opioid overdose deaths. If naloxone is administered quickly, it can counter the overdose effects, usually within minutes.
Read FDA News Release

FDA Proposes New Rule on Reporting Requirement Under Right to Try Act

The U.S. Food and Drug Administration published the proposed rule, Annual Summary Reporting Requirements Under the Right to Try Act, that when finalized, will implement a statutory requirement for sponsors and manufacturers to provide an annual summary to the FDA for any eligible investigational drug they provide to eligible patients under the Right to Try Act. “The FDA is dedicated to achieving the goals that Congress set forth in the Right to Try Act, so that patients facing terminal conditions have another avenue to access investigational medicines,” said Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs. “Today’s proposed rule builds on the FDA’s long-standing dedication to enhancing access for patients who are facing life-threatening diseases or conditions and our continued commitment to transparency.”
Read FDA News Release

FDA Recommends Health Care Professionals Discuss Naloxone with all Patients When Prescribing Opioid Pain Relievers or Medicines to Treat Opioid Use Disorder

FDA is requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder (OUD) to add new recommendations about naloxone to the prescribing information. This will help ensure that health care professionals discuss the availability of naloxone and assess each patient’s need for a naloxone prescription when opioid pain relievers or medicines to treat OUD are being prescribed or renewed. The patient Medication Guides will also be updated.
Read FDA Drug Safety Communication

FDA Notifies Companies, Including Puff Bar, to Remove Flavored Disposable E-Cigarettes and Youth-Appealing E-Liquids from Market for Not Having Required Authorization

The U.S. Food and Drug Administration issued warning letters notifying ten companies, including Cool Clouds Distribution Inc. (doing business as Puff Bar), to remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market because they do not have the required premarket authorization. These new actions are part of the FDA’s ongoing, aggressive effort to act against illegally marketed tobacco products amid the public health crisis of youth e-cigarette use in America. The agency is particularly concerned about the appeal of flavored, disposable e-cigarettes to youth and continues to monitor all available data.
Read FDA News Release

Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders

FDA guidance document describes the processes available to mammography facilities to request additional review of an adverse appeals decision on a facility's accreditation, and/or a suspension or revocation of certificate, and/or a patient and physician notification (PPN) order. This guidance, when final, will supersede section 4.5 of the Center for Devices and Radiological Health (CDRH) Appeals Processes guidance document dated July 2, 2019. The remainder of the July 2, 2019 CDRH Appeals guidance, with exception of technical edits for consistency with the newly amended section 4.5, will not be substantively changed and will remain in effect.
Read FDA Guidance Document

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.