FDA and Pharmacy Weekly Digest - May 7

Alerts / May 7, 2019

Acting Commissioner Sharpless Speaks at FDLI Annual Conference – The acting commissioner covered opioids, the safety of imported foods and possible changes to the cosmetics regulatory regime during his address to attendees at the 2019 FDLI Annual Conference.

Food/Dietary Supplements

FDA Announces Steps Toward Smarter Food Safety – Acting Commissioner Sharpless issued a press release announcing that it would create a “Blueprint for a New Era of Smarter Food Safety.” The blueprint will cover food traceability, digital technologies and food e-commerce.


FDA Approves Vaccine for Prevention of Dengue Disease – The FDA announced the approval of a vaccine to prevent dengue disease in endemic regions. The vaccine is approved for individuals ages 9-16 “who have laboratory-confirmed previous dengue infection and who live in endemic areas.”

FDA Approves Pediatric Hepatitis C Treatment – The FDA announced the approval of the first pediatric treatment for all genotypes of hepatitis C. The treatment is approved for children ages 12-17.

FDA Requires Additional Warnings for Certain Insomnia Medications – The FDA announced that it will require a boxed warning on certain prescription insomnia medications “to better ensure patients and their health care professionals have the information they need when considering use of these medicines. The boxed warning follows several reports of rare but serious injuries and deaths resulting from various complex sleep behaviors after taking these medicines. These complex sleep behaviors may include sleepwalking, sleep driving and engaging in other activities while not fully awake, such as unsafely using a stove.”

FDA Publishes Guidance on ADHD Treatment Development – The FDA issued a guidance titled “Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment Guidance for Industry.” The guidance is meant “to provide general framework recommendations to sponsors developing stimulant drugs for treatment of attention deficit hyperactivity disorder (ADHD) in pediatric and adult patients.”

Medical Devices

FDA Announces Steps to Ensure Safety of Breast Implants – A part of the FDA’s ongoing concerns regarding breast implants, the FDA announced that it would be taking additional “steps to improve the information available to women and health care professionals about the risks of breast implants that would include addressing the risk of BIA-ALCL, the greater risk of BIA-ALCL with textured implants, and the risk of developing systemic symptoms that would contribute to the patient-provider discussion about breast implants.”


​FDA Permits Sale of Tobacco Heating System – The FDA authorized the IQOS Tobacco Heating System through the premarket tobacco product application pathway. The system is “an electronic device that heats tobacco-filled sticks wrapped in paper to generate a nicotine-containing aerosol.”


FDA Chief Counsel Discusses Compounding and Opioids at FDLI – Stacy Amin discussed compounding and opioid enforcement at the 2019 FDLI Policy Conference. Amin stated, “Compounding is an enforcement area that has significant personal importance to me. Compounded drugs can pose unique risks. They’re not FDA approved and they don’t undergo premarket review for safety, effectiveness or quality.” With respect to the opioid crisis, Amin indicated that the FDA was working to curb illicit internet sales of opioids and secure the drug supply chain.

Citizen Petition Filed to Address a Bulk Drug Substance – An organization submitted a Citizen Petition requesting that the FDA amend 21 C.F.R. § 216.23 to include oxitriptan on the 503A Bulks List.

Authorship Credit: Lindsay P. Holmes

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