United States: FDA's Enforcement Priorities Likely To Change In 2017 And Other "Unknowable Knowns"

Last Updated: January 20 2017
Article by Joanne S. Hawana and Bethany J. Hills

As we enter a new era in which executive agencies are headed by President Trump, we are also faced with many other transformative changes that will affect FDA-regulated entities in a significant and lasting way. This post will outline some of our thoughts related to what could face FDA and its various stakeholders as we go forward into the great unknown.

First, since being signed into law by President Obama on December 13th, we've been writing and speaking about the myriad provisions of the 21st Century Cures Act. This wide-ranging law has many mandates for agency actions and new guidance documents, which FDA will be working on beginning this year, but far beyond 2017 as well. Drug, biologic, and medical device stakeholders are also awaiting the outcome of the upcoming reauthorization of all the major User Fee Acts that are "must-pass" legislation before the end of the current fiscal year (FY17 ends on September 30th), in order to ensure FDA's continuing operations. Many other policy changes that are expected to result from the switch from a Democratic-led to a Republican-led Executive Branch, the latter also being supported by a GOP-controlled Congress, will likely have major impacts on medical product developers. 

A Disclaimer: Although as of today, without a definitive announcement from President-elect Trump about his pick to lead the Agency, it is somewhat difficult to make detailed predictions about what lies in store for FDA this year (or, for that matter, the next four years), we thought describing some trends and our general thoughts could be valuable. Some of these areas could be affected by the next FDA Commissioner, but it takes time and not an inconsiderable amount of buy-in from career Agency staff to make major changes in longstanding programs and initiatives, so less politically controversial issues are unlikely to be revisited in the short-term.

Regulations: When it comes to new regulations, it remains to be seen what steps Congress takes under the Congressional Review Act (see here and here) to roll back Final Rules promulgated since last May. But for any FDA regulations that remain in proposed rule form, don't lose sleep waiting for them to be finalized – one thing the incoming Administration has made clear is its disdain for "government regulation" writ large, and we expect that to translate into new leadership taking a hard look at everything that's currently in the pipeline.  Thus, some of the rules listed in the Agency's Fall 2016 Unified Regulatory Agenda as pending a proposed regulation are likely to be taken off the table altogether.

Guidance: For FDA guidance documents, which everyone refers to in order to understand the Agency's "thinking" even though technically they are non-binding on all parties, it is a simple matter for the next Commissioner to order individual centers and offices to withdraw either a Final Guidance or a Draft Guidance by providing written notice to affected parties in the Federal Register. Unlike final regulations, these documents are not subject to the notice-and-comment provisions of administrative law that require the same public consultation process to be undertaken for the rescission of regulations currently in effect.

So several of the more controversial or legally questionable guidance documents may be withdrawn by FDA following the change in leadership. One good example here would be the recent draft guidance that creates a quality metrics reporting program for pharmaceutical manufacturers, as that guidance was not well-received by industry. At the same time, however, we could see relatively fast action by the new FDA to issue guidance on certain subjects that current Agency leadership has delayed or been hesitant to act upon even with significant and diverse stakeholder pressure.  The prime example being guidance on the permissible scope of off-label communications by medical product manufacturers. Indeed, off-label communications and related enforcement are one area where we expect a significant policy change to be implemented by the Trump Administration.

Enforcement: Finally, some enforcement priorities and initiatives are likely to change in the near term as well.  Although it is unlikely that the next Administration will alter FDA's enforcement activities and policing of serious public safety issues – examples would be issuing safety communications when illegal drug residues are found in dietary supplement products, or sending Warning Letters when a compounding pharmacy is found to have insanitary operations – there may enter a more laissez-faire climate when it comes to enforcement of "victimless" regulatory violations. One area where this is likely would be in the enforcement of cosmetic labeling rules that do not allow cosmetic products to be labeled with claims that they can alter the structure or function of the skin or other parts of the body (because such claims would make the product a "drug" under the law). Over the past two years, FDA has markedly and aggressively increased its policing of these claims by issuing regulatory letters to manufacturers and requiring them to undertake corrective actions. In our view, those cosmetic enforcement actions are likely to be history, at least for now or until the political pendulum swings again.

There are some areas where we don't anticipate any changes, at least not noticeably for those of us outside of the Agency and looking in. For example, FDA has been busy implementing the Biologics Price Competition and Innovation Act and its new pathway for biosimilar products, as well as working with biosimilar developers and reviewing their marketing applications. This program is unlikely to see much attention from the Trump Administration, except perhaps to urge regulators to work more quickly and to help get more biosimilars to market. Similarly, the Agency as well as State regulators and affected industry alike have been working for years towards a food safety system for a modern, globalized supply chain in response to the Food Safety Modernization Act of 2011. So unraveling the complex and interlocking regulations that emerged from that food safety modernization process may be politically unpopular (assuming such an activity would not be administratively impossible, for all intents and purposes); only one of the seven major foundational Final Rules issued under FSMA falls within the window that would allow it to be considered for rescission under the Congressional Review Act. In general, therefore, we are not expecting a sea change in the area of foods.

It is also possible that President-elect Trump's seeming disdain for the outsourcing of drug manufacturing operations to countries like India and China will impact whether he would have his FDA Commissioner continue the high level of inspection activity of those facilities.  On the one hand, a large number of foreign manufacturing sites have been the subject of regulatory action (including some Import Alerts) due to their failure to comply with cGMPs and, in some cases, their use of outright fraudulent data in their quality systems. But on the other hand, ramping down inspections and regulatory actions makes it more difficult for those facilities to be given a clean bill of health by the Agency so that they can export products to the U.S., which would be equivalent to implementing a new regulatory policy through administrative inaction.

And we close with a shameless plug: As a reminder, for our readers in the New York region, please register to join us for our in-person presentation in our Manhattan offices on Tuesday, January 24th. The event will feature a discussion of the Agency's priorities for 2017, and the potential impact of the Trump administration on FDA regulated companies. Rodney Whitlock from ML Strategies will also discuss the expected health care activity generally in the 115th Congress. The 1-hour seminar kicks off at 5:30 pm and will be followed by a cocktail reception. We hope to see you there!

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
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
McDermott Will & Emery
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