United States: FDA And Pharmacy Weekly Digest - March 12

FDA Commissioner Announces Resignation – Food and Drug Administration Commissioner Scott Gottlieb announced his resignation, citing personal reasons. The commissioner, who is well-known for his active role on Twitter, will be leaving the FDA around the end of the month. Secretary of Health & Human Services Alex Azar tweeted, "All of us at @HHSGov are proud of the remarkable work @SGottliebFDA has done at FDA. The public health of our country is better off for the work the @US_FDA team has done over the last two years, and I will personally miss working with Scott."

Food/Dietary Supplements

FDA and USDA Enter Cell-Cultured Foods Agreement – The two agencies announced the completion of a formal agreement for the regulation of cell-cultured food products from the cell lines of poultry and livestock. The agreement outlines a "shared regulatory approach." Specifically, "the agencies agree upon a joint regulatory framework wherein FDA oversees cell collection, cell banks, and cell growth and differentiation. A transition from FDA to FSIS oversight will occur during the cell harvest stage. FSIS will oversee the production and labeling of human food products derived from the cells of livestock and poultry."

FDA Deactivates Import Alert on Genetically Engineered Salmon – The FDA announced that it would deactivate a 2016 import alert on genetically engineered salmon. The statement indicates that the FDA "no longer has the authority to issue labeling guidance on this topic; however, the FDA believes this Congressional mandate has been satisfied by the USDA's issuance of final regulations implementing that law in late 2018 because the law and regulations require that human food containing GE salmon bear labeling indicating that it is bioengineered."


FDA Issues Updated Guidance on Nonproprietary Naming of Biological Products – The FDA published a draft guidance titled "Nonproprietary Naming of Biological Products: Update." The guidance outlines the "FDA's current thinking on nonproprietary names of biological products licensed under section 351 of the Public Health Service Act (PHS Act) that do not include an FDA-designated suffix." The press announcement states, "The naming policy will provide consistency among biologics and will help ensure health care providers and patients have confidence in the safety and effectiveness of any biological product on the market."

HHS Continue to Encourage Trump's Proposal to Lower Drug Costs – In January, the Trump Administration  proposed to end drug rebates to middlemen, like PBMs, and would instead allow such savings be passed directly to the consumer. HHS recently stated, "This proposal could usher in the single-biggest change to how drugs are priced at the pharmacy counter, delivering directly to patients and their pocketbooks the discounts drug companies currently give to middlemen today."

Medical Devices

FDA Alerts Providers About Safety of Surgical Staplers/Staples – The FDA announced steps to reduce the risks related to the use of surgical staplers for internal use and implantable surgical staples. The FDA has become aware of safety concerns with these products through numerous medical device reports. The FDA issued a letter to providers with recommendations for the safe use of these products. The announcement also indicates that the FDA plans to issue a new draft guidance on the subject this year.


FDA Announces New Actions to Curb Youth E-Cig Access – Commissioner Gottlieb issued a statement describing the FDA's new actions to prevent youth access to e-cigarette products. The FDA sent a letter to one retailer "request[ing] a meeting to discuss whether there is a corporate-wide issue related to their stores' track record of violating the law by illegally selling tobacco products to kids." The FDA also "identified 15 national retail chains, either corporate-owned or franchised, whose rates of violative inspections exceed 15 percent of their total inspected stores since the inception of the FDA's retailer compliance check inspection program in 2010." The commissioner stated that the FDA "will ask them to share with us what policies they have in place and what more they can commit to do to prevent youth tobacco sales. Companies should be on notice that the FDA is considering additional enforcement avenues to address high rates of violations."


FDA Issues Safety Alert for Several Claire's Cosmetic Products – The FDA issued a safety alert covering three Claire's cosmetic products after samples tested positive for containing asbestos. Commissioner Gottlieb tweeted, "After receiving these results, #FDA asked Claire's to recall these products, but they refused. FDA does not have authority to mandate a recall for cosmetics, so we issued a safety alert to warn consumers not to use the 3 Claire's products."

FDA Seeks to Improve Cosmetic Product Safety – The FDA announced new steps to improve the safety of cosmetics. The announcement states that the FDA will be "calling upon the cosmetic industry to take important new steps. Ultimately, the FDA also seeks to engage with stakeholders to work on other new opportunities to improve our overall framework for assuring the safety of the cosmetic products that consumers use." The FDA will be seeking information from manufacturers about procedures used to ensure that their products are safe and encouraging cosmetic firms to voluntarily register with the FDA.


FDA Publishes 503B Bulks List – The FDA published the much-anticipated 503B Bulks List. The list does include two bulk drug substances that will not be included on the list of substances that can be used in compounding under section 503B of the FD&C Act, nicardipine hydrochloride and vasopressin.

Gottlieb Maintains Compounding is a High Priority – In his statement regarding the FDA's FY 2020 budget request, FDA Commissioner Gottlieb listed high priority initiatives, including "advanc[ing] new steps to support the production of quality compounded drugs". Gottlieb expounded, "To address both the need for, and safety of, compounded products, the FDA is supporting new policy development for outsourcing facilities, including efforts to improve the quality of outsourcing facilities' compounded products. We're also helping address providers' needs for office stock of compounded medications. In 2020, for example, we're standing up a Compounding Center of Excellence, to provide training programs on good manufacturing practices for outsourcing facilities and adding a cadre of inspectors for outsourcing facilities."

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