FDA and Pharmacy Weekly Digest - April 9

Alerts / April 9, 2019

Sharpless Begins as FDA Acting Commissioner – On April 5, Norman E. “Ned” Sharpless, M.D., became the acting commissioner of the FDA. Previously he was the director of the National Cancer Institute.

SEC Chairman Release Statement on Commissioner Gottlieb’s Departure – The chairman of the U.S. Securities and Exchange Commission released a public statement thanking Commissioner Gottlieb for his service. He stated, “In carrying out my responsibilities as Chairman of the SEC, I have looked internally and externally for benchmarks – ways to measure the effectiveness of our efforts and identify opportunities for improvement. For the past two years, I have often looked to Dr. Gottlieb as a shining standard for agency leadership. Dr. Gottlieb, thank you for your service, and for the example you have set.”

Food/Dietary Supplements

April Is Winning on Reducing Food Waste Month – In partnership with the U.S. Department of Agriculture and the U.S. Environmental Protection Agency, the FDA announced the beginning of Winning on Reducing Food Waste Month. The Commissioner called for “greater collaboration with public, private, and nonprofit partners, as well as state and local officials, to educate and engage consumers and stakeholders throughout the supply chain on the need to reduce food loss and waste.”


FDA Warns Homeopathic Product Producers – The FDA warned four producers of homeopathic products about “significant violations of current good manufacturing practice regulations,” including lack of “quality oversight while manufacturing homeopathic drug products containing ingredients with potentially toxic effects for consumers, including snake venom.”

FDA Focuses on Insulin Pricing – The FDA reiterated its continued focus on the need for competition in the insulin market. One of the FDA’s plans is to change the approval pathway for insulin from a drug approval pathway to a biologics approval pathway, which the FDA believes “will open up these products to biosimilar competition.” FDA Commissioner Gottlieb stated that the FDA is “already seeing robust activity among sponsors seeking to bring forward biosimilar copies of insulin.” The FDA will also hold a public hearing on May 13, 2019, “to discuss access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products.”

FDA Evaluates Regulatory Pathways for Cannabis Products – The FDA announced its continued efforts to evaluate the possibility of regulatory pathways for products containing cannabis and those derived from cannabis. The FDA plans to hold a public hearing on May 31, 2019, to “give stakeholders an opportunity to provide the FDA with additional input relevant to the agency’s regulatory strategy related to existing products, as well as the lawful pathways by which appropriate products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient.” The FDA has also formed a working group to focus on the topic and issued “multiple warning letters to companies marketing CBD products with egregious and unfounded claims that are aimed at vulnerable populations.”

FDA Expresses Concern About Certain Stem Cell Products – The FDA issued a press release reiterating the importance of stem cell products and research; however, it also addressed bad actors, stating that “some actors are leveraging the widespread belief in the eventual promise of these products, flouting the statutes and our regulations, and deceiving patients by illegally manufacturing or selling purported therapies, and falsely promoting their benefits. This ultimately puts at risk the very patients they claim to want to help.”

FDA Warns Genomics Lab for Marketing Unreviewed Genetic Test – The FDA announced the issuance of a warning letter to a genomic laboratory for marketing genetic tests that “have not been reviewed by the FDA for safety and effectiveness.” The release states, “The tests claim to predict patients’ responses to specific medications based on genetic variants. Selecting or changing drug treatment in response to the test results could lead to potentially serious health consequences for patients. The FDA is unaware of any data establishing that Inova’s tests can help patients or health care providers make appropriate treatment decisions for the listed drugs.”

FDA Issues REMS Guidance – The FDA released a guidance titled “REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary.” The guidance is meant “to clarify how the Food and Drug Administration … applies the factors set forth in section 505-1 of the Federal Food, Drug, and Cosmetic Act … (21 U.S.C. 355-1) in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks.”

Medical Devices

FDA Addressed Medical Devices Based on Artificial Intelligence (AI) – The FDA is considering a new regulatory framework for AI-based medical devices. FDA released a discussion paper “to help developers bring artificial intelligence devices to market.”

FDA Seeks to Bolster Access to Animal Product Adverse Event Reports – The FDA announced that it will make available adverse event reports related to medical devices used in animals and animal drug products going back 30 years.


FDA Announces Workshop to Support Youth Tobacco Cessation – The FDA will hold a public scientific workshop on May 15, 2019, to “discuss scientific understanding and treatment options for youth tobacco addiction and cessation, with a focus on e-cigarette cessation.”

FDA Investigates Seizures Reported After E-Cig Use – The FDA notified the public of a potential safety issue related to e-cigarette use. It stated, “We have reports indicating that some people who use e-cigarettes, especially youth and young adults, are experiencing seizures following their use.” The FDA also stated, “We want to be clear that we don’t yet know if there’s a direct relationship between the use of e-cigarettes and a risk of seizure. We can’t yet say for certain that e-cigarettes are causing these seizures.”


Congress Questions Commissioner Gottlieb on Compounding – During the House Appropriations Committee Hearing on April 3, Rep. Cuellar asked, “How is the FDA taking small pharmacists’ issues with regulations regarding distribution and dispensing of medications into consideration?” Commissioner Gottlieb responded, “What we want to do is make it easier and less expensive for the 503A pharmacies to become 503B pharmacies, outsourcing facilities, and what we ‒ what we believe is by developing a center that can work more directly with pharmacies, help them ‒ help train them on how to meet GMP requirements, provide a higher level of touch, train them on how to be inspected.”

Commissioner Gottlieb Comments on Opioid Summit – The FDA held its second Online Opioid Summit. Commissioner Gottlieb’s comments focused on illicit internet trafficking of opioids. He stated, “Cutting off this illicit internet traffic is critical. And we’ll continue to pursue all available means of enforcement to stop these online drug dealers.” He indicated that the FDA and U.S. Customs and Border Protection will be “working to maximize each agency’s inspection and detection capabilities to protect Americans from illegal and harmful products entering the U.S. through the nation’s International Mail Facilities and Ports of Entry.”

FDA Warns Internet Providers of Opioid Medications – The FDA issued warning letters to two “websites that illegally market potentially dangerous, unapproved and misbranded opioid medications, including tramadol.”

FDA Seeks to Improve the Quality of Compounded Drugs – Commissioner Gottlieb and Deputy Commissioner Abram issued a statement about the FDA’s commitment to quality compounded drug products. They stated that the FDA plans to use appropriated funds to set up the Center of Excellence on Compounding for Outsourcing Facilities, which will include “trainings on current good manufacturing practice requirements for outsourcing facilities. The goal will be to bolster the quality of compounded drugs produced by outsourcing facilities.” They also stated that the FDA plans to finalize the compounding memorandum of understanding in 2019. In addition, on May 21, 2019, the FDA will hold a public meeting titled “Drugs Compounded for Office Stock by Outsourcing Facilities.” This meeting is intended to give “health care professionals, outsourcing facilities, and other stakeholders an opportunity to discuss access to office stock from outsourcing facilities considering the policies proposed in the revised draft guidance Current Good Manufacturing Practice Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.”

VA Passes Law Adding Pharmacy Protections – The Virginia legislature recently passed HB2561, which provides additional protections to pharmacies interacting with pharmacy benefit managers. The law requires that PBM contracts contain certain terms relating to pharmacy audits, including a 14-day notice period.

Authorship Credit: Lindsay P. Holmes

Baker & Hostetler LLP publications are intended to inform our clients and other friends of the firm about current legal developments of general interest. They should not be construed as legal advice, and readers should not act upon the information contained in these publications without professional counsel. The hiring of a lawyer is an important decision that should not be based solely upon advertisements. Before you decide, ask us to send you written information about our qualifications and experience.