FDA and Pharmacy Weekly Digest - December 3

Alerts / December 3, 2019
Food/Dietary Supplements

FDA Issues Warning Letters to Companies Selling Cannabidiol-Containing Products – The FDA announced it issued warning letters to 15 companies “for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).” FDA also issued an updated safety alert about these products titled “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD.”

Food Manufacturer Agrees to Cease Production – The FDA reported that a California-based food manufacturer “has agreed to discontinue selling food products until the company complies with federal regulations and other requirements. This action follows several inspections conducted by the FDA, which found Listeria monocytogenes (L. mono) in the company’s food preparation area and that the company was holding food for distribution in insanitary conditions.”


FDA Comments on Interchangeable Insulin Products – The FDA stated that it is “committed to continuing our efforts to help increase market competition among insulin products, which may potentially lower costs for patients and payors and increase access and product choice. This includes facilitating the development of safe and effective insulin products for the treatment of patients with Type 1 and Type 2 diabetes, including products that are biosimilar to, or interchangeable with, an approved insulin product. To inform product developers who intend to seek the FDA’s approval of proposed insulin products that are biosimilar to, or interchangeable with, an approved insulin product, the FDA today issued a draft guidance for industry, ‘Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.’ This draft guidance is intended to help guide efficient product development by clarifying what data and information may – or may not – be needed to support a demonstration of biosimilarity or interchangeability for a proposed insulin product, as defined in the draft guidance.”

FDA Uses International Collaboration for Chronic Lymphocytic Leukemia Treatment – The FDA announced, “Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada, the U.S. Food and Drug Administration granted supplemental approval to Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This new approved indication for Calquence provides a new treatment option for patients with CLL or SLL as an initial or subsequent therapy.”

FDA to Hold Public Meeting on Medication Adherence – The meeting will be held on Dec. 10, 2019, and will cover the following: (1) current landscape of interventions intended to (a) track (monitor) medication adherence, (b) improve medication adherence and (c) improve clinical outcome(s) due to increased medication adherence; (2) measurements of medication adherence; and (3) study designs to evaluate the effectiveness of FDA-regulated products intended to track and/or improve medication adherence, with or without an association to clinical outcomes.

FDA Issues Guidance on Certificates of Confidentiality – The draft guidance outlines the FDA’s “implementation of the revised provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC). The 21st Century Cures Act (Cures Act) (Public Law 114-255) amended the Public Health Service Act (PHS Act), section 301(d) (42 U.S.C. 241(d)) relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom identifiable, sensitive information is being collected or used in furtherance of the research. Historically, a CoC generally protected a researcher from being compelled to disclose identifiable and sensitive information about the research participant, created or compiled for purposes of the human subject research. As amended, the statute broadened the protections by affirmatively prohibiting holders of CoCs from disclosing such information unless a specific exception applies.”

FDA Publishes Guidance on Adaptive Clinical Trial Design – The guidance outlines the “appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biologic. The guidance describes important principles for designing, conducting, and reporting the results from an adaptive clinical trial. The guidance also advises sponsors on the types of information to submit to facilitate FDA evaluation of clinical trials with adaptive designs, including Bayesian adaptive and complex trials that rely on computer simulations for their design.”

Medical Devices

FDA Orders Fertility Clinic to Immediately Cease Manufacturing – The press announcement states that an inspection of the Puerto Rico-based facility “revealed significant violations of regulations regarding donor eligibility determinations, including donor screening and testing. The clinic’s failure to fulfill these requirements puts patients at risk for exposure to communicable diseases, including HIV and hepatitis.”

FDA Addresses Concerns About Medical Device Sterilization – The FDA announced “the next steps we’re taking in our ongoing efforts in medical device sterilization with ethylene oxide. This includes the selection results of our two new Innovation Challenges to accelerate the development and review of sterilization technology innovations, as well as a recap and action items that came out of our recent public advisory committee meeting on how best to encourage innovation in medical device sterilization. Further, we’re also announcing a new pilot program for industry to expedite approvals of certain changes to ethylene oxide sterilization processes and facilities.”


FDA Clarifies Policy on Making Limited Safety-Related Modifications to Certain Tobacco Products – The FDA stated that it issued a guidance document “which sets out the FDA’s compliance policy for limited safety modifications to tobacco products on the market as of Aug. 8, 2016: (1) battery-operated tobacco products modified solely and only to the extent necessary to comply with the voluntary industry UL 8139 battery standard; and (2) e-liquid products containing nicotine modified solely and only to the extent necessary to comply with the restricted-flow requirements for liquid nicotine containers set out in the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA). This guidance explains that the FDA does not intend to enforce violations of the premarket review requirements against such modified products on the basis of these limited modifications.”


Canada Expresses Concerns About Drug Importation Proposals – As reported by The Hill, Canada’s acting ambassador to the U.S. stated, “‘It is important to recognize that Canada’s market for pharmaceuticals is too small to have any real impact on U.S. drug prices … Canada’s priority is to ensure a steady and solid supply of medications at affordable prices for Canadians.’”

Massachusetts Legislators Introduce Emergency Insulin Bill – The bill will allow a pharmacist to dispense a 72-hour supply of insulin in an emergency situation.

Authorship Credit: Lindsay P. Holmes

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