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News and Trends Impacting the FDA and Life Science Industry

FDA PUBLIC MEETING RECAP: FDA REVISITS “HEALTHY” CLAIMS

Posted in Advertising and Promotion, Beverages, Foods, Labeling, Regulation

Food and BeverageOn March 9, 2017, the U.S. Food and Drug Administration (“FDA”) held a public meeting to invite public comments on the possibility of redefining use of the term “healthy” in the labeling of human food products.  The FDA’s reconsideration of the “healthy” claim criteria follows recent FDA guidance on this issue, and is related to a broader set of recent regulatory actions that are designed to update FDA regulations to more accurately reflect current nutritional science.

  The public meeting was attended by hundreds of stakeholders from across the food and beverage industry, and included general informational presentations and “breakout” sessions that focused, among other things, on consumer perceptions of “healthy” claims and whether “healthy” should be defined as a “nutrient-based” claim, a “food-component” claim, or both.  The FDA is accepting written comments on a potential new definition of “healthy” until April 26, 2017.

  Here’s a quick review of the issue and where things stand after the public meeting:

   Why is the FDA reconsidering the definition of “healthy” claims?

                Current FDA regulations allow for the use of “healthy” and similar terms (e.g., “health,” “healthful,” “healthier,” etc.) as implied nutrient-content claims on food labeling subject to two conditions that relate to nutrients that should be limited or encouraged in the diet.  You might think of it this way: the FDA does not permit you to make “healthy” claims on foods that contain too much potentially bad stuff (total fat, saturated fat, cholesterol or sodium), or too little of certain good stuff (vitamin A, vitamin C, calcium, iron, protein and fiber).  The specific criteria vary for different food categories, and the criteria are generally linked to elements in the Nutrition Facts panel and serving size regulations.  All of these regulations, however, were implemented in the early 1990s, when nutrient science focused on limiting total fat intake and remedying certain nutritional deficiencies that were identified as public health concerns.  As science and nutrient intakes have evolved over time, the focus has shifted from total fat reduction to encouraging certain types of fats (e.g., mono and polyunsaturated fats), and deficiencies in vitamins A and C are no longer public health concerns but have given way to new concerns about deficiencies in vitamin D and potassium intake.  As FDA’s recent changes to the Nutrition Facts panel and serving size regulations reflect this new science, FDA plans to update its other nutrition labeling regulations, including those for “healthy” nutrient-content claims, to align with the other recent changes.  

  What different approaches to a new definition are currently being discussed?

 The primary discussion at the recent public meeting focused on consumer perception of “healthy” claims, as well as on whether “healthy” claims should remain nutrient-based claims or instead should be redefined in terms of specific food groups or overall healthy dietary patterns. 

  With respect to consumer perception, there was general acknowledgement that consumer attitudes vary widely and can be hard to determine, although there is a growing trend with many consumers to look to “whole” foods or less processed and nutrient-dense options (e.g., natural sugars versus “added” artificial sugars), even when such foods have higher levels of nutrients that should be limited.  Although concerns were expressed about whether an adequate definition of “healthy” is realistic given the diversity of consumer behaviors, and some encouraged deleting the regulatory definition altogether, others emphasized the need for the industry to define “healthy” claims to avoid the ambiguity and litigation that has arisen over unregulated terms like “natural.” 

Discussion regarding whether “healthy” claims should be nutrient-based claims or based on specific food groups generally converged on the potential need for a definition that incorporates the benefits of both types of approaches.  There was acknowledgement that certain nutrient limitations were appropriate, that some deficiencies remain public health concerns, and that the current list of nutrients for which limits are prescribed should be revised (e.g., to add sugar, remove cholesterol, etc.).  Others emphasized that maintaining “healthy” as a nutrient based claim was particularly important for certain types of foods (e.g., processed foods), but less important for others (e.g., raw fruits and vegetables), and so a dual paradigm or one that focused nutrient criteria on specific categories of foods might be more appropriate.  Other comments focused on how to define or address nutrient density, the role of fortification, and defining “healthy” in terms that allow consumers to connect entire foods, not specific nutrients, to overall healthy dietary patterns.

 How can industry provide comments and what should we expect next from the FDA?

The public comment period on a new definition of “healthy” ends April 26, 2017.  The agency’s request for comments, which also sets forth the types of issues on which the agency is soliciting information, is available here and provides instructions for submitting handwritten or electronic submissions.  After the comment period closes, the FDA will review the public comments and make a determination on whether and how to revise the “healthy” definition.  Although the FDA has provided no specific timeline for when this might occur, the revision to the definition of “healthy” is partly driven by changes to the Nutrition Facts Panel, and industry must begin to comply with those new requirements as early as July 26, 2018.

Will there be changes in enforcement as the FDA considers a new “healthy” definition?  

Yes.  The FDA has issued guidance to notify manufacturers of its intent to exercise enforcement discretion in relation to “healthy” claims when they are made on two types of foods.  First, the FDA will exercise enforcement discretion with respect to the current requirement that “healthy” foods meet a low fat requirement, provided that the foods have a fat profile makeup of predominantly mono and polyunsaturated fats.  Second, the FDA will also exercise enforcement discretion with respect to the current requirement that “healthy” foods contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of vitamin A, vitamin C, calcium, iron, protein, or fiber, so long as the food instead contains at least ten percent of the DV per RACC of potassium or vitamin D.  A copy of the enforcement guidance is here.

Conclusion

The FDA is revisiting its definition of “healthy” for the first time in nearly twenty-five years.  As evidenced by the large attendance at the recent public meeting and the nearly 900 comments submitted on the docket to date, the comment period is an important opportunity for clients in the food and beverage industry to shape the policy on this important issue.   The Food and Beverage Industry Team at McGuireWoods LLP has extensive experience advising clients on regulatory issues, and is available to respond to your questions about the public comment process.

 

Patent Settlements and Antitrust: Update on the EU Position

Posted in Antitrust, Drugs, European Union, Generic Drugs, Litigation

EU building (vertical)Ever since the publication in July 2009 of the report on its antitrust inquiry into the pharmaceutical sector, the European Commission (EC) has been monitoring patent settlement agreements between originator and generic companies in the EU (plus Norway, Iceland, and Liechtenstein, thus making up the European Economic Area (EEA)). This monitoring was started, because the inquiry identified settlements that limit generic entry and provide at the same time for a value transfer from the originator to the generic company (“pay-for-delay”) as potentially raising antitrust concerns in the EU/EEA. Continue Reading

Tradjenta® Patent Infringement Allegations Dismissed for Covering Unpatentable Abstract Ideas

Posted in Drugs, Litigation, Patents

On December 8, 2016, Judge Sheridan of the District of New Jersey dismissed infringement allegations for various claims of U.S. Patent No. 8,853,156 (“the ’156 patent”), because they cover unpatentable abstract ideas.  The ’156 patent is alleged to cover Tradjenta®, which contains the active ingredient linagliptin and is FDA-approved as an adjunct treatment for Type 2 diabetes.  The asserted claims related to DPP-IV inhibitors, a class of compounds which is said to be eliminated via hepatic metabolism or biliary excretion, therefore avoiding side effects associated with renal excretion. Continue Reading

NYSBA – DC Holiday Networking Event – Reciprocity Issues for New York-Admitted Lawyers Featured

Posted in Meetings

McGuireWoods DCNew York State Bar Association (NYSBA) DC- Area members are cordially invited to our Wednesday, December 14th NYSBA-DC event!

Holiday Networking Event: Reciprocity Issues for New York-Admitted Lawyers

Come join other NYSBA-DC area members in an information-sharing event to discuss reciprocity issues for New York-admitted lawyers — lawyers moving from state to state and dealing with bar licensure in various states, and how it is done in New York.

Guest Speakers:

Margaret Nyland Wood, Esq., Assistant Deputy Clerk, New York State Court of Appeals

Kellie Early, Esq., Chief Operating Officer, National Conference of Bar Examiners, Madison, WI

Hosted by: Brian Malkin, Senior Counsel, McGuire Woods LLP

Date: Wednesday, December 14, 2016

Check-in: 4:45 pm

Program Begins: 5 PM

Wine & Cheese Reception: 6-7 PM

Location: McGuire Woods LLP  2001 K Street NW, Suite 400, Washington, DC 20006

Cost: FREE for NYSBA members

To Register: Reciprocity Issues for NY Admitted Lawyers

Please note: You will need to log in to www.nysba.org in order to register. If you need help with your NYSBA login in, please call our Member Resource Center at 800-582-2452.

For more information: pwood@nysba.org

We hope to see you on December 14th!

Food Safety Law Treatise Updated – Release Number 11 Now Available

Posted in Beverages, Foods

ljp-Food-Safety-Law-coverMcGuireWoods’ Food and Beverage Industry Team is proud to have written the nation’s leading treatise on Food Safety Law.  Jim Neale and Angela Spivey co-authored the authoritative work, which should be on the bookshelf of anyone practicing in the regulatory compliance or litigation of food safety arenas.  The treatise enjoys a foreword by Bill Marler, one of the nation’s leading plaintiff’s side food safety attorneys and is updated twice a year to ensure that it contains the most timely and relevant information.  Release Number 11 is now available.  It features a detailed discussion of the long-awaited final rules implementing the Food Safety Modernization Act, such as the Sanitary Transport Rule, the Food Defense Rule, and the Hazard Analysis and Risk-Based Preventive Control Rule. It also addresses the FDA’s new Generally Accepted as Safe (“GRAS”) and Nutritional Labeling Rules.  In addition, this Release analyzes the latest case law on consumer class action lawsuits challenging food labeling; insurance and indemnity caselaw relating to food production and food contamination; and causation in foodborne illness cases. Release 11 also discusses the National Bioengineered Food Disclosure Standard, which will create, for the first time, a uniform federal law on GMO and bioengineering disclosure, displacing state laws such as Vermont Act 120.  The treatise is available in print and electronic form and should be part of the library of any reader of FDA Life.  You can order your copy at this LINK

 

Susan Winckler Featured Keynote Speaker This Week at 8th Annual Pharmaceutical and Medical Device Conference in Chicago on November 10

Posted in Advertising and Promotion, Animal Drugs, Antitrust, Biological Products, Clinical Studies, Drugs, Emerging Growth, Enforcement, European Union, FDA Organization, Healthcare, Intellectual Property, Legislation, Litigation, Medical Devices, Meetings, Patents, Regulation

159161119On November 10, 2016, McGuireWoods LLP and McGuireWoods Consulting (“McGuireWoods”) will be holding its 8th Annual Pharmaceutical and Medical Device Conference in Chicago.  Kicking off the Conference will be Keynote Speaker, Susan Winckler, the Chief Risk Management Officer for Leavitt Partners as well as a lead contributor in the firm’s alliance management and regulatory consulting activities.  Winckler, a pharmacist and attorney by training, is the former FDA Chief of the Staff and former President and Chief Executive Officer of the Food and Drug Law Institute, a nonprofit organization based in Washington, D.C., which provides a marketplace for discussing food and drug law issues through conferences, publications, and member interaction. Continue Reading

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NYSBA’s REMS and Other Drug Distribution Restrictions Program Provided an Excellent and Informative Discussion

Posted in Antitrust, Drugs, Generic Drugs, Legislation, Litigation

New York CityOn November 3, 2016, the New York State Bar Association’s Sections, Food, Drug and Cosmetic Law and Antitrust Law, held a program in New York City: “REMS and Other Drug Distribution Restrictions: When Does a Brand Company Have a Duty to Deal with its Generic Rivals?”  The program featured both federal and state antitrust lead attorneys working on these issues, as well as counsel for both reference and generic applicants, including:

Elinor R. Hoffmann, Office of the New York State Attorney General

Peter Safir, Covington & Burling LLP

Daniel W. Butrymowicz, Federal Trade Commission

Seth Silber, Wilson Sonsini Goodrich & Rosati 

Moderators:

William Reiss, Robins Kaplan LLP

Janet B. Linn, Bleakley Platt & Schmidt, LLP Continue Reading

REMS and Other Drug Distribution Restrictions – Special NYSBA Program Will Be Held November 3 in NYC

Posted in Uncategorized

Risk185953030On November 3, 2016, the New York State Bar Association’s Sections, Food, Drug and Cosmetic Law and Antitrust Law, will put on a program in New York City: “REMS and Other Drug Distribution Restrictions: When Does a Brand Company Have a Duty to Deal with its Generic Rivals?”  The program will be held from 6:00-9:00 pm with a reception (cocktails and hors d’oeuvres) to follow.   The speakers below feature both federal and state antitrust lead attorneys working on these issues, as well as counsel for both reference and generic applicants, to provide for a lively and informative discussion and dialog. Continue Reading

McGuireWoods 8th Annual Pharmaceutical and Medical Device Conference in Chicago on November 10

Posted in Biological Products, Drugs, Medical Devices, Meetings

159161119Join us for an interactive conference addressing key legal and business matters focusing on innovation, investing, and regulatory issues in the pharmaceutical and medical device sectors.

Topics

  • Executive Roundtable – Life Sciences Industry Update
  • FDA Update – Recent Developments and New Initiatives Impacting Pharmaceutical and Medical Device Companies
  • HCP Relationships and Enforcement Issues
  • Brexit Update
  • Financing Alternatives for Life Sciences Companies
  • Business and Legal Issues for Early-Stage Companies
  • Patent Prosecution and Litigation Issues for Life Sciences Companies
  • Hot Button ‎Antitrust Issues for Life Science Companies
  • Business and Legal Issues in Clinical Research Arrangements
  • Company Presentations

Continue Reading

Regulatory Misconduct Reporting Hits CDRH’s Website – Plus Upcoming FDA Public Hearing On Off-Label Communications

Posted in Advertising and Promotion, Enforcement, Medical Devices, Meetings

Healthcare False ClaimsOn October 21, 2016, at the end of the week of AdvaMed 2016, FDA’s Center for Devices and Radiological Health (CDRH) unveiled its new page, “Reporting Allegations of Regulatory Misconduct.”  According to the new page: Continue Reading

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