United States: FDA And Pharmacy Weekly Digest - April 23

Acting FDA Commissioner Holds First All-Hands Meeting – During his first all-hands meeting, Acting Commissioner Sharpless indicated that he would be revealing his priorities for the agency in the coming weeks. He stated that the following principles would aid in his decision-making: “a commitment to science-based decision-making and prioritizing our efforts for the benefit of the public health.”

Food/Dietary Supplements

FDA Issues Allulose Guidance – The FDA published a draft guidance relating to the declaration of certain nutrition information for products that contain the sweetener allulose. The guidance also addressed the caloric calculation of allulose. According to the press announcement, “FDA is advising manufacturers that it intends to exercise enforcement discretion regarding the requirement that the sweetener allulose be included in the amount of Total Sugars and Added Sugars on the Nutrition Facts label.”

FDA to Hold Public Meeting on Dietary Supplements – The FDA will hold a public meeting to address responsible innovation in the dietary supplement industry. The meeting will be held May 16, 2019.

FDA Announces Dietary Supplement Ingredient Advisory List – The FDA issued a press release about its new tool to notify the public of ingredients that are being illegally marketed in dietary supplements. FDA plans to add ingredients to the list “following an initial FDA assessment indicating the ingredient may not lawfully be in dietary supplements.”

Drugs/Biologics

FDA to Hold Public Meeting on Impact of Rare Diseases – The FDA will hold a public meeting titled “Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities” on April 29, 2019. The purpose of the meeting is “to obtain patients’ and caregivers’ perspectives on impacts of rare diseases on daily life and to assess commonalities that may help the Agency and medical product developers further understand and advance the development of treatments for rare diseases.”

FDA Approves First Generic Naloxone Nasal Spray – The FDA announced approval of the first generic naloxone hydrochloride nasal spray. This medication “can stop or reverse the effects of an opioid overdose.” Due to the severity of the opioid crisis, FDA plans to prioritize review and approval of more generic application for this product.

FDA Releases Bispecific Antibody Guidance – The FDA issued a guidance document titled “Bispecific Antibody Development Programs.” The guidance is intended to give “recommendations to assist industry and other parties involved in the development of bispecific antibodies. Discussion includes general considerations and recommendations for bispecific antibody development programs, as well as regulatory, quality, nonclinical and clinical considerations in the context of bispecific antibody development programs.”

Medical Devices

FDA Takes Action Against Surgical Mesh Manufactures – The FDA ordered manufacturers of surgical mesh for transvaginal repair of pelvic organ prolapse to cease distribution of their products immediately.

FDA Approves First ADHD Treatment Device – The FDA announced the approval of the first medical device intended to treat attention deficit hyperactivity disorder (ADHD). The product is “indicated for patients ages 7 to 12 years old who are not currently taking prescription ADHD medication and is the first non-drug treatment for ADHD granted marketing authorization by the FDA.”

Pharmacy

States Continue to Consider PBM Legislation – The Illinois House recently voted to pass a bill that adds additional requirements related to pharmacy benefit management (PBM) contracting. Arkansas’s governor recently signed into law SB 520, which requires PBM reporting of rebates and prohibits “spread pricing,” which is defined as a model in which “the pharmacy benefits manager charges a health benefit plan a contracted price for prescription drugs, and the contracted price for the prescription drugs differs from the amount the pharmacy benefits manager directly or indirectly pays the pharmacist or pharmacy for pharmacist services.”

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