United States: FDA and Pharmacy Weekly Digest - May 14

Food/Dietary Supplements

FDA Releases Food Contact Guidance – The FDA published a guidance titled "Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk: Guidance for Industry." The guidance is the FDA's "current thinking on recommendations for preparation of food contact notification (FCN) submissions for food contact substances (FCSs) used in contact with infant formula and/or human (breast) milk. This document is intended to provide specific guidance to help manufacturers or suppliers submitting an FCN in the safety assessment of substances that are intended for use in contact with infant formula and/or human milk."

Drugs/Biologics

FDA Issues Final Guidance on Topical Active Ingredients – The FDA released a final guidance titled "Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The-Counter Monograph: Study Elements and Considerations." The guidance is intended to provide "recommendations for the conduct of in vivo absorption trials for topically applied active ingredients that are under consideration for inclusion in an over-the-counter (OTC) drug monograph." The guidance outlines recommendations for the design and implementation of a maximal usage trial.

FDA Issues Guidance on Clinical Lactation Studies – The FDA released a draft guidance titled "Clinical Lactation Studies: Considerations for Study Design." The guidance is intended to "provide recommendations for sponsors conducting clinical lactation studies." The FDA also released a draft guidance titled "Postapproval Pregnancy Safety Studies." The draft guidance is intended "to provide sponsors and investigators with recommendations on how to design investigations to assess the outcomes of pregnancies in women exposed to drugs and biological products regulated by the FDA (i.e., pregnancy safety studies)."

Acting Commissioner Sharpless Speaks on Interchangeable Biosimilars – The Acting Commissioner announced a final guidance addressing the pathway for interchangeable biologics. Sharpless stated, "Today's final guidance gives an overview of important scientific considerations in demonstrating interchangeability with a reference product and explains the scientific recommendations for an application or a supplement for a proposed interchangeable product. Once an application or supplement seeking licensure as an interchangeable product is submitted, the FDA will approve the biological product as interchangeable with the reference product if the information submitted in the application or the supplement is sufficient to meet the applicable statutory standard: among other things, that the biological product is biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient." Later in the week, the acting commissioner spoke about interchangeable insulin products specifically.

FDA Publishes Abbreviated Approval Pathway Guidance – The FDA issued a guidance titled "Determining Whether to Submit an ANDA or a 505(b)(2) Application." The guidance is "intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) is appropriate for the submission of a marketing application to FDA."

Medical Devices

FDA Release Guidance on Q-Subs – The FDA issued a final guidance titled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program." The guidance outlines "the mechanisms available to submitters through which they can request feedback from or a meeting with the Food and Drug Administration (FDA) regarding potential or planned medical device[s]."

Tobacco

Advocacy Groups Pen Letter About E-Cig Marketing – A number of advocacy groups sent a letter to Acting Commissioner Sharpless urging him to investigate the marketing tactics of an e-cigarette manufacturer "and take appropriate enforcement action against, the marketing of ... e-cigarettes with express or implied claims that the products help users stop smoking."

Pharmacy

More Than 40 States File Drug Price-Fixing Suit – The lawsuit alleges "a broad conspiracy to artificially inflate and manipulate prices, reduce competition and unreasonably restrain trade for more than 100 different generic drugs."

Two GA Anti-Steering Bills Become Law – Georgia's governor signed into law HB 323 and HB 233. One bill prohibits pharmacies from steering patients to affiliates for any commercial purpose. The other requires that PBMs report certain rebates, and prohibits them from requiring that insureds fill prescriptions at affiliate pharmacies.

Connecticut Passes Hemp Bill – Connecticut's governor signed into law SB 893, which authorizes an industrial hemp pilot program. The program is being "established for the purpose of studying the growth, cultivation and marketing of industrial hemp in a manner that ensures that only such department grows or cultivates such industrial hemp through the use of sites that are certified by, and registered with, the Department of Agriculture."

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