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."

Drugs/Biologics

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FDA Publishes Marketing Status Notification Guidance – This draft guidance, entitled "Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format Guidance for Industry," sets out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FDA Issues Rare Disease Drug Development Guidance – FDA released a draft guidance to address avenues for more efficient drug development programs specific to products intended to treat or prevent rare diseases.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.

Pharmacy

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.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions