FDA and Pharmacy Weekly Digest - October 24

Alerts / October 24, 2019
Food/Dietary Supplements

FDA Acting Commissioner Remarks on Smarter Public Food Safety – Dr. Sharpless stated, “I have been [a] strong proponent of leveraging new and emerging technologies and of developing novel analytical tools in the service of saving lives throughout my career, so doing this for food safety makes perfect sense to me. Harnessing computing power and applying state-of-the-art data storage and computing to support initiatives are approaches I fully believe in, and they play a key role in the New Era of Smarter Food Safety. We will employ such approaches to mine new types and sources of data and we will develop new ways to share those data, allowing us to work together across public and private sector boundaries in the development of new possibilities and solutions for food safety.”


FDA Emphasizes Importance of Low-Cost Drugs – In a recent statement from the FDA, Acting Commissioner Sharpless stated, “Safe, effective and high-quality generic drugs play a vital role in our health care system. Generic drugs account for about 90% of all prescription drug purchases in the U.S. In 2018, competition from generic drugs saved the health care system about $293 billion…. The value of our generic drug program runs deep, and we are engaged in a number of efforts to help ensure the program remains vibrant. We’re encouraged to see that the pipeline of generic drug applications is strong and that there is ongoing interest in the development of generic versions of complex drugs and of other drugs with inadequate generic competition. In the coming months, we plan to publish additional guidances and take other important policy steps to assist generic drug applicants, including planning additional conferences on generic drug development to further engage with stakeholders and generic drug developers. We will continue to do all that we can to facilitate a stable, competitive market to increase access to medicines.”

FDA Approves Cystic Fibrosis Breakthrough Therapy – The FDA announced the approval of “the first triple combination therapy available to treat patients with the most common cystic fibrosis mutation.” The application was granted priority review, fast-track status and a breakthrough therapy designation.

FDA and FTC Jointly Warn About Cannabidiol Products – The agencies issued a joint warning letter to a company for selling unapproved CBD products “online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson’s and Alzheimer’s disease, among other conditions or diseases.” The FDA stated that it “continues to be concerned about the proliferation of products claiming to contain CBD that are marketed for therapeutic or medical uses that have not been approved by the agency. The FDA approval process ensures that drugs on the market are safe and effective for their intended therapeutic uses. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas and topical lotions and creams. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy. There is very limited information for other marketed CBD products, which likely differ in composition from the FDA-approved product and have not been evaluated for potential adverse effects on the body.”

FDA Releases PDUFA Guidance – The guidance titled “Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry” is intended to give “recommendations to applicants regarding requests for waivers, refunds, 17 and reductions of user fees assessed under sections 735 and 736 of the Federal Food, Drug, and 18 Cosmetic Act (the FD&C Act) for drugs, including biological products.2 This guidance is a 19 revision of the guidance for industry entitled User Fee Waivers, Reductions, and Refunds for 20 Drug and Biological Products, issued in September 2011.”

FDA Publishes DMF Guidance – The FDA issued a draft guidance titled “Drug Master Files Guidance for Industry” that gives “FDA’s current thinking on drug master files (DMFs), which are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.”

FDA Issues Final Guidance on Manufacturing Establishments – The guidance titled “Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers” provides clarification on the FDA’s “expectations regarding facility information that should be included in original new drug application(s) (NDA); abbreviated new drug application(s) (ANDA); original biologics license application(s) (BLA); amendments; supplements; chemistry, manufacturing, and controls (CMC) supplements; and resubmissions to these submission types. Submission of Form FDA 356h fulfills the requirement for applicants to submit an application form (21 CFR 314.50(a) and 314.94(a)(1); 601.2(a)).”

FDA Announces Draft Guidance on Postmarketing Studies and Clinical Trials – The guidance titled “Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry” gives “information on the implementation of section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(o)(3)), which authorizes FDA to require certain postmarketing studies and clinical trials for prescription drugs approved under section 505(c) of the FD&C Act and biological products approved under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262).”

FDA Releases Guidance on HIV Pre-Exposure Prophylaxis Products – The guidance titled “Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis” provides “nonclinical and clinical recommendations specific to the development of systemic drug products, with a focus on long-acting systemic drug products, regulated within the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA) for the prevention of sexually acquired human immunodeficiency virus-1 (HIV-1) infection.”

FDA Issues Guidance on Vaccine Datasets – The guidance titled “Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review” outlines “detailed information and specifications for the content of datasets submitted to FDA’s Center for Biologics Evaluation and Research (CBER) Office of Vaccines Research and Review (OVRR) and is designed to aid clinical and statistical reviewers in the review of vaccine applications, e.g., biologics license applications.”

Medical Devices

FDA Remarks at FDLI Medical Product Advertising and Promotion Conference – At the conference, the principal associate commissioner for policy stated, “I think most would agree that it’s important to have appropriate guardrails, enforced by FDA and others, to protect patients and the public health. Of course, there’s room for debate about what those guardrails should look like.… I’m not talking about good faith debate regarding how best to protect and promote the public health. I’m talking about bad actors who are all too willing to endanger consumers by selling harmful products that often are not FDA-approved for any use, and that often aren’t manufactured in accordance with any appropriate standards.”

FDA Will Hold Webinar of Special 510(k) Program Final Guidance – The FDA announced a webinar set for Oct. 31, 2019, “for device manufacturers and industry to discuss and answer questions about the Special 510(k) Program Final Guidance.”


FDA Grants First Modified Risk Order for Smokeless Tobacco – The FDA announced “that, for the first time, it has authorized the marketing of products through the modified risk tobacco product (MRTP) pathway.” The authorization applies to eight snus smokeless tobacco products.

FDA Acting Commissioner Speaks at NIH Tobacco Regulatory Science Meeting – Dr. Sharpless stated, “We look to your research findings for several key things, including to help evaluate: potential product standards; whether the marketing of a product would be appropriate for the protection of public health; and whether a product meets the standard for authorization as a modified risk product, such as whether it will significantly reduce harm and the risk of tobacco-related disease.”

FDA to Hold a Public Meeting on Deemed Tobacco Products – The FDA’s announcement states, “This meeting is intended to provide information on the agency’s expectations for tobacco product applications with a particular focus on deemed tobacco products (e.g., cigars, waterpipe, and Electronic nicotine Delivery Systems (ENDS) including e-liquids and electronic cigarettes) including product review policies, procedures, and general scientific principles.”


Recall of Baby Powder Products – The FDA announced the voluntary recall of certain baby powder products “after FDA testing has found that a sample from one lot of the product contains chrysotile fibers, a type of asbestos.”


JAMA Publishes Assessment of Impact of Pharmacy Closures – The assessment “examined trends in pharmacy closures in the United States between 2009 and 2015, and analyzed pharmacy, community, and market factors that might be associated with such closures.”

Authorship Credit: Lindsay P. Holmes

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