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No Rest For The Weary; FDA Continues Torrid Pace

Posted: January 18, 2017

Late last month, I observed that FDA showed no signs of slowing down as the New Year rapidly approached. The Agency has continued its torrid pace, keeping food and drug lawyers and industry on their toes.
Here are a few notable FDA developments in the last couple of weeks:

  • FDA issued yesterday a draft guidance, "The Prohibition of Distributing Free Samples of Tobacco Products", which explains, among other things, what activities and which persons are subject to the Agency’s tobacco product free sample ban. While the Guidance predictably outlines FDA's prohibition on the distribution of free samples of tobacco products to consumers, it also indicates that the Agency does not intend to enforce the free sample ban with respect to businesses distributing free samples to other businesses in limited quantities (i.e., no more than necessary to achieve a business or marketing goal such as awareness of and exposure to a product for the purposes of product or inventory selection).
  • Also yesterday, the Agency released a draft guidance on demonstrating biosimilar interchangeability, "Considerations in Demonstrating Interchangeability With a Reference Product". Among other things, the guidance contains information on: factors impacting the type and amount of data and information needed to support a demonstration of interchangeability; the data and information needed to support such a demonstration; considerations for the design and analysis of a switching study or studies to support such a demonstration; recommendations regarding the use of U.S.-licensed reference products in a switching study or studies; and considerations for developing presentations (e.g., container closure systems) for proposed interchangeable products.
  • Last Friday, FDA released a laboratory developed test (LDT) discussion paper. Recall that in November, the Agency announced it was abandoning an effort to finalize its LDT draft guidance. In the absence of issuing final guidance and at the request of stakeholders, FDA decided to share its synthesis of all the feedback it has received thus far in order to advance public discussion on future LDT oversight. Although the discussion paper is not enforceable, the Agency telegraphs in the document its possible approach to LDT regulation, addressing topics such: as focused oversight (including "grandfathering" of certain previously-marketed tests); risk-based, phased in regulation; evidence standards (including the role of the Clinical Laboratory Improvement Amendments (CLIA) program, which is overseen by the Centers for Medicare and Medicaid Services (CMS)); third-party review; clinical collaboratives; transparency; test modifications; quality system (QS) requirements; and postmarket surveillance.
  • Lastly, on January 4th, the Agency issued two guidance documents on the nutrition facts label and serving size final rules. The nutrition facts guidance answers questions related to compliance, labeling of added sugars, rounding as it relates to the declaration of quantitative amounts of vitamins and minerals, and label format. The serving size guidance provides examples of food products that belong to product categories included in the tables of Reference Amounts Customarily Consumed (RACCs) per Eating Occasion that are established in FDA’s serving size regulations. The food product examples in the guidance are intended to help industry identify the appropriate food categories for their products and determine the serving size on a product’s Nutrition Facts label.

Please let me know if you have any questions on these or other issues.