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  March 2015

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC office, and articles from members of AGG outside the Food and Drug Practice.

In this Issue

 Industry Insights



FDA and Dispute Resolution: It’s Not Personal and Be Realistic
Alan G. Minsk

Recently, we were asked to speak to a group of C-Suite officials within the pharmaceutical industry in a particular therapeutic space. Our topic was the Food and Drug Administration and its Dispute Resolution process. Here, we will not describe FDA’s guidance document on the subject or the pros and cons of proceeding with such an approach; these are far too complex and numerous for this type of Bulletin. However, based on the Q&A that followed, which included a panel discussion with a former Division Director, as we have counseled clients with dispute resolution issues, we thought a few general observations are worthy of consideration. While our talk and subsequent panel was to a pharmaceutical audience, we believe the issues can apply equally to the medical device industry. More >



Reaching a State of Comfortably Numb: FDA Intends to Relax Enforcement for Certain Types of Medical Devices
By: Alan G. Minsk

On February 9, 2015, the Food and Drug Administration issued a final guidance, “Medical Device Data Systems [MDDS], Medical Image Storage Devices, and Medical Image Communications Devices,” in which it reversed, in part, its recently-issued enforcement approach for these devices. The agency concluded that it “does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices.” Therefore, the agency said that, for the aforementioned devices, it will not enforce compliance with requirements relating to establishment registration, product listing, premarket notification (i.e., a 510(k)), postmarketing reporting, and quality system regulations (QSRs). These requirements apply to Class I devices, but FDA intends to exercise enforcement discretion. More >

FDA Shows Displeasure with Leasing 510(k)s
By: Alan G. Minsk

Every week, we review a number of Warning Letters – fortunately, we review others companies’ enforcement letters more than having to respond for our clients. One recent Warning Letter issued by the Food and Drug Administration caught our eye, because this issue has come up before with clients – buying, selling or transferring a 510(k) versus leasing or licensing a cleared device to multiple firms. A recent Warning Letter, issued by a local district (not FDA headquarters), makes the distinction clear and describes what FDA allows. More >



Calorie Labeling Requirements Will Apply to Restaurants and Similar Retail Food Establishments
By: Matthew V. Wilson

A newly enacted FDA regulation, stemming from a provision in the Affordable Care Act, mandates that certain establishments, from hospitals to nursing homes, include calorie counts and other disclosures on all menus, menu boards, and at certain other designated locations. More >



Lawmakers Solicit Public Feedback on Legislation Intended to Expand Patients' Access to Drugs, Devices and Other Treatments
By: Alan K. Parver and Leah Mendelson Stone

On January 27, 2015 the House of Representatives Committee on Energy and Commerce released a discussion draft of a bill entitled, “21st Century Cures Act.” The bill includes several proposals that are intended to expand patients’ access to treatments and promote drug and device development. The Senate Committee on Health, Education, Labor and Pensions is engaged in a complementary effort to improve the development of drugs and devices, and on January 29 it released a report entitled, “Innovation for Healthier Americans.” The committees have solicited feedback from stakeholders. This bicameral initiative presents an opportunity for the public to participate in the development of legislation in this area, and to provide feedback on improving and expediting the processes for developing medical products and bringing them to market. More >

Industry Activities and Recognition

Alan Minsk Named to Who's Who

Alan G. Minsk was recently named as a Who’s Who among regulatory attorneys in the 2015 Life Sciences edition. Since 1996 Who's Who Legal has identified the foremost legal practitioners in 34 areas of business law in more than 100 countries. More >

Upcoming Events 

AGG Partner William H. Kitchens will present "FDA Regulation of Digital Health" at the Southeastern Medical Device Association 2015 Conference on March 31, 2015 in Atlanta, GA.

AGG Partner Alan G. Minsk will serve as a moderator for a panel on “The Use of Quality Agreements by Contract Manufacturing Organizations” at the International Pharmaceutical Expo (INTERPHEX) on April 22, 2015 in New York, NY.

AGG Partners Tenley A. Carp and Jeffrey Y. Lewis will present a complimentary webinar "Doing Business in the US: What Foreign Companies Need to Know About Government Contracts and Civil Litigation" on April 29, 2015.

This newsletter is published by Arnall Golden Gregory’s Food and Drug and Government Affairs and Public Policy Practices. This information presented provides a general summary of recent legal and regulatory developments. It is not intended to be, and should not be relied upon, as legal advice. For more information about the Food and Drug Practice, please contact Alan Minsk.
©2015. Arnall Golden Gregory LLP. All Rights Reserved.  Atlanta | Washington, DC

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