United States: BakerHostetler FDA And Pharmacy Weekly Digest - February 4, 2019

Food/Dietary Supplements

FDA Commissioner Takes to Twitter to Address Super Bowl Food Safety – Commissioner Gottlieb encouraged consumers to remember food safety when enjoying Super Bowl eats. He tweeted, "Our #FDA #SUNDAYTWEETORIAL is BACK! Are you throwing a party this #SuperBowl Sunday? Don't forget to tackle food safety. In today's Tweetorial, I'll be serving up a defensive game plan for how you can best protect your family and friends from foodborne illness during the telecast." In response to one Super Bowl commercial, he also tweeted, "#FDA strongly discourages people from drinking chunky milk. For some safe food tips during the #SuperBowl, see my #SUNDAYTWEETORIAL."


FDA Issues Guidance Related to Medically Necessary Drug Products – The FDA released a final guidance entitled "Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products." The purpose of the guidance is to "encourage manufacturers of medically necessary drug products (MNPs) and any components of those products to develop contingency production plans to use during emergencies that result in high absenteeism at production facilities." The guidance outlines certain considerations manufacturers should make when developing plans for production of the products in times of crisis.

FDA Releases Revised Guidance on Submissions in Electronic Format – The guidance entitled "Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product1 Applications and Related Submissions Using the eCTD Specifications Guidance for Industry" is applicable to NDAs, ANDAs, INDs and BLAs. It implements the electronic submission requirements set out in section 745A(a) of the FD&C Act.

FDA Publishes Marketing Status Notification Guidance – This draft guidance, entitled "Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format Guidance for Industry," sets out the required content and formatting for marketing status notifications for NDA and ANDA holders. FDA also announced that it plans to focus on enhancing the Orange Book, including clarifying Orange Book processes and issuing additional guidance documents related to therapeutic equivalence evaluations.

FDA Issues Rare Disease Drug Development Guidance – FDA released a draft guidance to address avenues for more efficient drug development programs specific to products intended to treat or prevent rare diseases. This guidance replaces a previous guidance issued in 2015.

Medical Devices

FDA Publishes Final Guidance on Antimicrobial Susceptibility Test Devices – FDA published a final guidance to address the development of antimicrobial drugs and susceptibility test (AST) devices. The guidance focuses on the coordination of drug and device development with respect to antimicrobial products. The guidance states, "Historically, the development of antimicrobial drugs and AST devices that test for in vitro antibiotic susceptibility of bacterial pathogens has not been optimally coordinated, with AST device development sometimes occurring late in the drug development process or after the drug development/approval process is completed." The guidance addresses new goals for coordinating development efforts to minimize delays in availability of AST products.

FDA Issues Abbreviated 510(k) Approval Pathway Guidance – FDA released a guidance to "describe an optional pathway – the Safety and Performance Based Pathway – for certain, well understood device types, where a submitter would demonstrate that a new device meets FDA-identified performance criteria to demonstrate that the device is as safe and effective as a legally marketed device." The guidance seeks to expand the abbreviated 510(k) approval pathway by explaining how the substantial equivalence demonstration may be conducted in a less burdensome manner.

FDA Commissioner Comments on Medical Device Cybersecurity – Commissioner Gottlieb remarked on FDAs concerns about the cybersecurity of legacy devices that "cannot simply be swapped out for newer models." He also announced that FDA will be participating in "DefCon's "We 'HEART' Hackers Challenge" – a white hat hacker event" in August 2019. The commissioner stated, "I want to add my voice in encouraging manufacturers to demonstrate their commitment to the principles of device resiliency and trustworthiness by volunteering to take the challenge and participate with their peers this year. And I want to recognize the extraordinary value that white hat hackers bring to the medical device ecosystem through efforts such as this one."

Commissioner Gottlieb Announces Record Year in Device Innovation – The commissioner stated, "Last year marked another record year, supported by the new policies, processes and programs we've implemented over recent years to help efficiently promote safe and effective innovation in medical device development. Last year, in 2018, the FDA approved 106 novel devices, surpassing the 40-year record we set in 2017 of 99[1] novel device approvals, and capping off eight years of steady improvement." He also announced that FDA plans to continue to implement the National Evaluation System for Health Technology, which seeks to generate better evidence for medical device evaluation and regulatory decision-making.

Recently Posted Warning Letters

FDA recently issued warning letters to a drug manufacturer for cGMP violations, a fertility center for violations of the HCT/P regulations, a food storage and distribution center for violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, a food processing facility for repeat violations of juice HACCP regulations, and an e-liquids company for alleged sale of tobacco products to a person younger than 18.


HHS Proposes Rule to Lower Drug Costs – The HHS secretary and inspector general announced a proposed rule aimed at lowering drug costs. Secretary Azar stated, "Every day, Americans – particularly our seniors – pay more than they need to for their prescription drugs because of a hidden system of kickbacks to middlemen. President Trump is proposing to end this era of backdoor deals in the drug industry, bring real transparency to drug markets, and deliver savings directly to patients when they walk into the pharmacy." The rule proposes to exclude rebates between manufacturers and pharmacy benefit managers from the Anti-Kickback Statute rebate safe harbor, but would establish a new safe harbor for discounts made available to patients.

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