United States: FDA And Pharmacy Weekly Digest - September 24

Last Updated: October 1 2019
Article by Lindsay P. Holmes, Lee H. Rosebush and Lance L. Shea

Food/Dietary Supplements

FDA to Hold Public Meeting on Food Standards of Identity – The FDA will hold a public meeting “to give interested persons an opportunity to discuss FDA’s effort to modernize food standards of identity and provide information about changes we could make to existing standards, particularly changes that could be made across categories of standardized foods (i.e., horizontal changes), to facilitate innovation and provide flexibility for the development of healthier foods.” The meeting will be held on Sept. 27, 2019.


FDA Announces International Collaboration with Australia and Canada – The FDA announced its first action in coordination with Australia and Canada for concurrent review of cancer therapies. The FDA stated, “The U.S. Food and Drug Administration is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, the Australian Therapeutic Goods Administration (TGA) and Health Canada collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in all three countries.”

FDA Releases Guidance on Novel Treatments for ALS – The FDA stated, “The final guidance includes up-to-date information on our recommendations to help advance the development of products for ALS patients, including recommendations on clinical trial design and ways to measure effectiveness. We know that an important element of product development is working early and often with researchers and companies to help facilitate their clinical development programs. That’s why our final guidance recommends that researchers and companies interact with the FDA early in product development so that we can best advise on proposed development programs and the efficient design of trials to produce the data needed for FDA approval in order to get effective therapies to patients as efficiently as possible. Because this guidance presents non-binding recommendations for the FDA and sponsors, the FDA is open to considering alternative approaches to meeting our requirements for approval.”

FDA Testifies Before the U.S.-China Economic and Security Review Commission – The associate commissioner for global policy and strategy submitted written testimony to the U.S.-China Economic and Security Review Commission regarding the growing reliance of the U.S. on China’s biotech and pharmaceutical products. The associate commissioner stated, “Our priorities in China are consistent with our priorities everywhere. The best way to ensure food safety and the integrity of medical products is to make sure firms consistently follow appropriate processes for safeguarding safety and quality in production. Manufacturers are best situated to ensure these processes, and regulatory bodies should hold companies accountable for lapses in the production process and not simply rely on testing after the fact to detect flaws. Inspections and testing play an important role in that process, but they need to be used as part of a larger system that emphasizes a systematic, proactive, preventive approach to strengthen the production of safe food and safe and effective medical products produced in China for export to the United States. And in our globalized world, it is increasingly important that regulatory partners work together to ensure the safety of products as they move across borders. While many future challenges remain as we engage Chinese regulators and industry on these key issues, we will continue to expand on successes attained in recent years.”

FDA Releases Guidance on Citizen Petitions – The guidance “revises the guidance for industry entitled ‘Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act’ issued in November 2014. This draft guidance updates the November 2014 guidance to account for recent regulatory changes and describes a change in FDA’s current thinking on what constitutes a 505(q) petition. In addition, FDA is revising this guidance to describe some of the considerations FDA will take into account in determining whether a petition is submitted with the primary purpose of delaying the approval of an application.”

FDA Publishes a Compliance Policy Guide (CPG) Related to Wholesale Distributors – The FDA issued a CPG “intended for wholesale distributors who must verify the product identifier upon receipt of a returned product that the wholesale distributor intends to further distribute as required under section 582(c)(4)(D) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(c)(4)(D)). This guidance addresses the readiness of wholesale distributors to comply with the provisions in section 582 of the FD&C Act related to the verification of saleable returned drug products. The requirement under section 582(c)(4)(D) for wholesale distributors to verify saleable returned drug products prior to redistribution goes into effect on November 27, 2019.”

Medical Devices

FDA Takes Additional Steps Toward a Modernized 510(k) Process – The FDA announced its first action to implement the Safety and Performance Based Pathway for medical devices. The FDA announced that it “is issuing draft guidance outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices. These are anticipated to be the first device types eligible for the new, voluntary premarket notification pathway to market devices, which was first announced in 2018 and finalized through guidance earlier this year.” FDA issued four draft guidances in conjunction with this announcement.

FDA Issues Guidance on Patient Engagement in Medical Device Clinical Investigations – The FDA released a draft guidance to provide “proposed recommendations for manufacturers to engage patients in multiple aspects of medical device clinical investigation design. The draft guidance is a reflection of our extensive work to engage patients into our medical product regulatory processes, which has grown since 1991 when the FDA first began including patient perspective in FDA Advisory Committee meetings, and continues today through our Patient Engagement Advisory Committee (PEAC).”


FDA Publishes Proposed Rule on PMTAs – The FDA announced the availability of a proposed rule outlining the “content, format and FDA’s review and communications procedures for premarket tobacco product applications (PMTAs) as part of the agency’s continued commitment to its oversight of e-cigarettes and other tobacco products. When finalized, this proposed rule will help to ensure that PMTAs contain sufficient information for evaluation such as details regarding the physical aspects of a tobacco product and information on the product’s potential public health benefits and harms. It also would codify the procedures by which the agency would review PMTAs and establish the requirements for manufacturers to maintain records related to the legal marketing status of their tobacco products.”


Drug Pricing Remains a Hot Topic on the Hill – House Democrats introduced legislation last week to lower prescription drug prices – including allowing Medicare to negotiate prices with manufacturers – and set an aggressive timeline to approve the bill by Halloween. See the full story on our Ohio Clock Blog.

FDA Pushes for Increased Access to Naloxone – The FDA stated, “Making naloxone more widely available in every pharmacy as an approved over-the-counter (OTC) product would also be an important public health advancement – one we have been working on at the FDA. In January, we took an unprecedented step in helping to encourage development of OTC naloxone products. To encourage drug companies to enter the OTC market, the FDA designed, tested and validated the key labeling requirements necessary to approve an OTC version of naloxone. To do this, we developed a model Drug Facts Label (DFL) with pictogram instructions so anyone with access to the drug can better understand how to administer it. To ensure the pictograms are easy to understand, we also conducted label comprehension testing with consumers. This was the first time the FDA proactively developed and tested a DFL to support development of an OTC product.”

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