United States: BakerHostetler FDA And Pharmacy Weekly Digest - November 19, 2018

Last Updated: November 23 2018
Article by Lindsay P. Holmes

Food/Dietary Supplements

2016 Foodborne Illness Report Released – The Food Safety Analytics Collaboration released a new report titled "Foodborne illness source attribution estimates for 2016 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States." The report reviewed more than 1,000 foodborne illness outbreaks from 1998 to 2016 to determine which foods resulted in the most outbreaks of certain foodborne illnesses.

Pet Food Recall Expanded – A Missouri company expanded a voluntary recall for a formula of dog food due to elevated levels of vitamin D after receiving complaints from several pet owners.

Registration for FDA Public Meetings on Produce Safety Open – FDA will be holding four public meetings to discuss a draft guidance titled "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry." Registration is now open for these meetings.

FDA Extends Comment Period for Names of Dairy Foods – FDA announced that it plans to extend the comment period for a request for information related to the "Use of the Names of Dairy Foods in the Labeling of Plant-Based Products." The comment period will be extended for 60 days.

Drugs

Commissioner Gottlieb Addressed Opioids – FDA released a statement from the commissioner, who indicated that FDA's focus has turned to clinical practice guidelines for prescribing opioids. The commissioner stated that FDA "want[s] to develop new science where more rigorous evidence is needed on the proper dose and duration of opioid analgesic use for the treatment of pain in some common, acute pain indications. Development of this evidence is needed in many areas when it comes to the treatment of pain." The commissioner also stated that "[h]aving clear, rigorous, evidence-based guidelines that guide the optimal dosing and duration of opioid analgesic use for the most common indications is the key to" reducing unnecessary exposure and making sure patients have access to necessary medications.

Drugs Added to the Shortage List – Three drug products have been added to the drug shortage list – Ketorolac Tromethamine Injection (Updated – Currently in Shortage), Sterile Water (Updated – Currently in Shortage) and Leucovorin Calcium Lyophilized Powder for Injection (Updated – Currently in Shortage).

Stem Cell Treatment Warned by FDA – FDA issued a press release along with a warning letter to a California laboratory warning it that its marketing of a stem cell product without FDA approval is prohibited. FDA also noted "evidence of significant deviations from current good manufacturing practice requirements in the manufacture of the ... product; including unvalidated manufacturing processes, an uncontrolled environment, lack of control over the components used in production, and the lack of sufficient and validated product testing."

Public Meeting on Drug Development Tool – FDA announced a public meeting to be held on Dec. 11, 2018, to discuss specific commitments FDA made under FDUFA VI and the 21st Century Cures Act. This meeting focuses on "taxonomy for biomarkers and related concepts used in drug development; and planning activities to define a framework with appropriate standards and scientific approaches to support qualification for a specified context of use (COU)."

FDA Issues Two Drug-related Guidance Documents – FDA released a guidance titled "Hypertension: Developing Fixed-Combination Drug Products for Treatment" and another titled "Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry." The meta-analysis guidance is meant to assist IND, NDA and BLA applicants who plan to utilize meta-analysis of randomized controlled clinical trials to evaluate and support the safety of products.

FDA Issues Rulemaking on IRB Waiver – FDA released a Notice of Proposed Rulemaking titled "Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations." This proposed rule "would allow an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects."

FDA Launches Program to Monitor Social Media – FDA announced that it plans "to use nontraditional sources to explore the social contexts in which substances are being used, as well as to identify potential drugs of concern that may be emerging. These data can provide clues about the dynamics of use, misuse and abuse, and potentially identify changing patterns."

Medical Devices

FDA Publishes Information Collection for Small Business –– FDA released a notice of information collection related to medical device user fees for small businesses. Written comments are accepted until Jan. 14, 2018.

Tobacco

FDA Announces Plans to Restrict Vape Sales – FDA announced it plans to curb youth access to certain flavored tobacco products. The policy includes a move toward selling all flavored ENDS products in age-restricted, in-person locations and a plan to remove ENDS products marketed to children.

Recently Posted Warning Letter

FDA recently issued warning letters to a drug company for failing to accurately list its products, a compounding pharmacy for preparing and holding sterile products in insanitary conditions, and a medical device company for failing to follow Quality System requirements when manufacturing its products.

Pharmacy

ESI and Pharmacy Settle Litigation –  ESI settled a lawsuit prior to trial regarding allegations that ESI violated federal antitrust laws by conspiring with other PBMs to boycott compounding pharmacies.

FDA Issues Safety Communication Related to Implanted Pumps – FDA released a safety communication titled "Use Caution with Implanted Pumps for Intrathecal Administration of Medicines for Pain Management: FDA Safety Communication." This communication is focused on providers, pharmacists, compounders and patients, and discusses "the risks of using medications delivered into the spinal fluid to treat or manage pain that are not approved for use with the implanted pumps."

FDA to Hold Public Meeting on Drug Shortages – On Nov. 27, 2018, FDA and the Center for Health Policy at Duke University will host a public meeting on drug shortages as part of the Agency's Drug Shortage Task Force. Topics include addressing the root causes of drug shortages and discussion of potential long-term solutions. FDA also opened a public docket on the topic, which will remain open until Jan. 11, 2019.

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
Wilson Elser Moskowitz Edelman & Dicker LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Wilson Elser Moskowitz Edelman & Dicker LLP
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must 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