United States: FDA-Regulated Industries: Plan Now For These Changes In 2016

* This is our second post on the regulatory road ahead for life sciences companies in 2016.  Our first post examined developments in food safety regulation under the Food Safety and Modernization Act.

In our last post, Life Sciences Decoded took a look at  new food industry regulations that will roll out in 2016 under the FDA's Food Safety and Modernization Act. But it's not just the food industry that will need to prepare for a new regulatory landscape and heightened enforcement this year.

Big changes are also in store for the industries of animal health, drug, medical devices and tobacco. Among these, the FDA is expected to continue its scrutiny of animal food safety, ramp up its work in post-approval drug studies and keep a close watch on the evolution of mobile medical devices and e-cigarettes. What follows are some regulatory highlights in each area to keep close tabs on as the year unfolds.

Animal health

Under the newly consolidated Center for Food Safety and Applied Nutrition, the FDA has very specific goals in continuing to ensure a safe food supply, not only for humans but animals, too.  This year, expect an increased regulatory emphasis on the cross-over market (human products to animal products).

Much of the focus will continue to be on food supply chain safety. The FDA is expected to inspect feed supply manufacturers for compliance with its newly promulgated safety standards and practices in accordance with its science-based preventive control standards. These inspections will include both processing facilities and transportation methods. In addition, the FDA will continue to promote its Retail Food Program Standards and continue to monitor how companies manage food contamination and record-keeping processes.

Along with an increased focus on animal food or feed animals, it is fully expected that the agency will continue to look at the use of antibiotics in feed animals and continue to use its administrative new drug application review process to move products to the animal health market.

Drugs

It is expected that while the Office of Inspector General (OIG) will focus efforts on activities subject to the Drug Supply Security Act, particularly Section 202, the FDA will focus its efforts on continued clinical trials post-approval, as well as on its pharmaceutical quality action plan. The FDA also intends to continue its efforts in patient-focused drug development. Specifically, we can expect to see:

  • Increased oversight of postmarketing studies of approved drugs and increased requirements for postmarketing studies.
  • Continued use of clinical outcomes assessment (COA) and the use of the compendium of COAs to not only influence the development of drugs and drug labels but to assist in drug approvals.
  • A review of the rate at which members in a given drug's supply and manufacturing chain share information and enable drug traceability to ensure that the industry is meeting traceability requirements.
  • Public commentary on the draft Guidance "Safety Assessment for IND Safety Reporting," published in December 2015.
  • Continued focus on sunscreen safety after the Sunscreen Innovation Act of 2014. The FDA published three draft Guidance documents in November 2015 concerned with the accuracy of sunscreen safety and efficacy as part of 586A applications for FDA findings of Generally Recognized As Safe and Effective (or GRASE) for new sunscreen additives or combinations of additives.

Medical devices

The Center for Devices and Radiological Health (CDRH) will continue to closely examine medical devices, software applications and related cybersecurity issues. This will include a continued look at devices such as mobile medical applications. In fact, in an effort to get the year off to an early start, on Jan. 22, 2016, CDRH issued draft guidance on Postmarket Management of Cybersecurity in Medical Devices. The Guidance discusses the FDA's recommendations to the device industry on how to identify and address cybersecurity vulnerabilities for marketed medical devices.

Devices that use software in their applications will be subject to a higher level of scrutiny. Where vulnerabilities are identified, these devices and their sponsors will be required to engage in remediation. Particular areas to watch include:

  • A review of how hospitals and medical device manufacturers secure electronic Protected Health Information and its use over hospital networks;  ensure that processes are in place to proactively plan for security of all patient data and that such processes comply with the Quality System Regulations, in addition to the new Guidance.  
  • Continued evolution of the new GUDID device labeling system and database in response to industry and consumer studies. This includes both industry-facing updates, as well as back-end improvements after a significant outage in the fourth quarter of 2015.
  • A 2.3 percent excise tax applied to medical device companies under the Affordable Care Act was suspended for 2016 and 2017.

If you are interested in this topic, Thompson Coburn will be hosting a webinar on March 16 titled "Medical Mobile Apps: An Overview of the Regulatory Environment."

Tobacco

In 2014, the FDA proposed its "Deeming" rule, which, if finalized, would make many tobacco products (including cigars and e-cigarettes, or vaporizers) subject to the FDA's jurisdiction and, therefore, its tobacco regulations. These regulations would include facilities, product, and ingredient registrations, bans on free samples, labelling requirements, and limits on the kinds of allowable marketing and advertising claims.

However, even through 2015, the Deeming Rule remains only as a proposed rule, despite the FDA's best efforts to advance it. But even with this stalemate, the FDA's Tobacco Center has implemented new regulations affecting tobacco products and their entry into the market as evidenced by the implementation of premarket tobacco applications for new tobacco products. This is a new pathway to market for tobacco products that creates a new regulatory hurdle for the tobacco industry requiring them institute and implement a regulatory strategy for their new products to ensure that they can obtain a favorable review of premarket applications. In addition, the FDA will continue its efforts through 2016 in filing complaints against retailers using No-Tobacco-Sale Order actions.

Time to act

FDA-regulated companies must be doing more than just thinking about the impact of these regulations. Instead, they should be drafting a plan for compliance and thinking through the implementation of these plans. The time is fast-approaching when the FDA will commence inspections and subsequent enforcement actions.

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
McDermott Will & Emery
Akin Gump Strauss Hauer & Feld LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
McDermott Will & Emery
Akin Gump Strauss Hauer & Feld 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