FDA Stakeholder Update - December 23, 2019

Dear Colleague, FDA's Stakeholder Engagement Staff works to provide you with up-to-date information to further our commitment to advance public health and well-being.

FDA takes efforts to improve quality of compounded drugs from outsourcing facilities through collaboration and education as part of new Center of Excellence Compounded drugs can serve an important role in meeting patients’ medical needs that cannot be met by an FDA-approved drug. Outsourcing facilities, a significant part of the industry producing compounded drugs used by hospitals, clinics, providers, and other health care systems, have rapidly evolved since the passage of the Drug Quality and Security Act (DQSA) in 2013. Although compounded drugs can fill an important role for patients and the FDA recognizes the need to preserve access to these products, they may also present a greater risk to patients because, among other things, they are not required to undergo the agency’s premarket review for safety, effectiveness and quality. [12/19/19] Statement on National Academies of Sciences, Engineering, and Medicine report on framing opioid prescribing guidelines for acute pain In August 2018, the U.S. Food and Drug Administration contracted the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of evidence-based guidelines for opioid analgesic prescribing for acute pain resulting from specific conditions or procedures. NASEM was tasked with providing a framework to evaluate current and future opioid prescribing to support a clinical practice guideline and to identify gaps in the evidence where future research is needed. We greatly appreciate all the work done by NASEM to produce the consensus report released today. [12/19/19] Trump Administration takes historic steps to lower U.S. prescription drug prices President Trump, along with the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration, issued a notice of proposed rulemaking (NPRM) that, if finalized, would allow for the importation of certain prescription drugs from Canada. In addition, the Administration is announcing the availability of a new draft guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country. [12/18/19] Statement on low-cost biosimilar and interchangeable protein products Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is key for expanding access to these products and increasing competition, ultimately helping American patients. In March 2020 most protein products that were approved as drug products (including every insulin currently on the market) will open up to biosimilar and interchangeable competition. However, “chemically synthesized polypeptides” are excluded from this transition, which means that a product that falls within this category won’t be able to come to market as a biosimilar or interchangeable product, but will have to come to the market under a different pathway. [12/18/19]

FDA in Brief FDA provides clarity regarding evidence needed to demonstrate effectiveness for drugs and biologics FDA issued the draft guidance, Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. This guidance complements and expands on the 1998 guidance, Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. Although the FDA’s standard for demonstrating effectiveness has not changed since the publication of the 1998 guidance, the evolution of drug and biologic development and science has led to changes in the types of product development programs submitted to the agency. [12/19/19] New analysis highlights link between generic drug competition and lower drug prices, underscores importance of FDA efforts to spur generic drug development and market entry FDA posted a new analysis showing greater competition among generic drug makers is associated with lower generic drug prices. [12/13/19] FDA issues draft guidance to foster oncology product development for pediatric populations FDA issued a draft guidance document, “FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act.” The draft guidance addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs for which original new drug applications and biologics license applications are expected to be submitted to the FDA on or after August 18, 2020, in accordance with section 505B of the Federal Food, Drug, and Cosmetic Act, which was amended by the FDA Reauthorization Act of 2017. [12/12/19]

Request for Comment Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products by 02/21/2020 This document is intended to provide guidance to applicants planning to file new drug applications (NDAs), biologics license applications (BLAs), or applications for supplemental indications on the evidence to be provided to demonstrate effectiveness. This guidance complements and expands on the 1998 guidance entitled Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (the 1998 guidance). Bridging for Drug-Device and Biologic-Device Combination Products by 02/18/2020 This guidance provides recommendations to industry and FDA staff on how to approach bridging in new drug applications (NDAs) or biologics license applications (BLAs) for drug-device and biologic-device single entity or copackaged combination products including the following: Bridging of information related to a combination product that employs a different device constituent part or parts with the same drug constituent part or parts as the proposed combination product Bridging of information related to a combination product that employs a different drug constituent part or parts with the same device constituent part or parts as the proposed combination product

Guidance Document Nutrition and Supplement Facts Labels Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals This guidance is intended for conventional food and dietary supplement manufacturers. It provides questions and answers on topics related to compliance with our final rules issued on May 27, 2016, entitled “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (81 FR 33742; the “Nutrition Facts label final rule”) and “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments” (81 FR 34000; the “serving size final rule”) (codified at title 21 of the Code of Federal Regulations, part 101 (21 CFR part 101)).

Consumer Updates Some Medicines and Driving Don’t Mix If you’re taking a medication, is it safe to drive? Most likely, yes. Still, the FDA advises you to make sure before operating any type of vehicle, whether a car, bus, train, plane, or boat. Some medicines can affect your driving for a short time after you take them. For others, the effects can last for several hours, and even the next day. And some medicines have a warning to not operate heavy machinery — this includes driving a car.