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   August 2016

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



You Wear It Well (or Do You?): FDA Objects To These Skincare Companies' Unapproved New Drug Claims
By: Alan G. Minsk 

In the 1972 hit, “You Wear it Well,” Rod Stewart sang about a woman and offered the classic line, “Madame Onassis got nothing on you.” The tune came to mind when reading four Warning Letters issued by the Food and Drug Administration in July against skincare companies marketing unapproved new drug claims. FDA didn’t think the companies wore it well. We have written in the past about the Food and Drug Administration’s enforcement against skincare companies marketing claims that the agency considered to be unapproved new drugs. FDA is out in force again with a slew of Warning Letters. All of the Letters came from District offices. More >

Does Mikey really “Like It?” – New Media Advertising and the Use of Endorsements
By: Matthew V. Wilson

Any casual user of new (digital) media can attest to the growing popularity of the medium among advertisers. Solicitations promoting goods and services now pepper the newsfeeds of Facebook, Instagram and Twitter, (for example), paid advertisements introduce most YouTube videos, and ads even sneak their way into the most private and seemingly closed platforms, such as Pinterest. Among the many advertising techniques employed in the social media space, the user endorsement reigns supreme. Through celebrity testimonials, user reviews, and product placements, advertisers are able to directly, and oftentimes seamlessly, reach a broad and sophisticated audience without much effort or expenditure. 
More >



Well, Well, Well – What Do We Have Here: FDA Eases Up On Regulating General Wellness Products
By: Alan G. Minsk and Elizabeth A. Mulkey

The Food and Drug Administration ("FDA") has issued guidance on general wellness products, which are low risk products it will not regulate as “medical devices.” A draft of the guidance was issued in January 2015, and the final guidance, “General Wellness: Policy for Low Risk Devices,” was issued in July 2016. This Bulletin summarizes the guidance and offers our own observations.  More >

When It’s Time to Change, You’ve Got to Rearrange: FDA Issues Draft Guidance on When Changes to an Existing Medical Device Require a New 510(k)
By: Alan G. Minsk 

Many of us remember the classic 1972 Brady Bunch song, “Time to Change,” when Peter Brady sings (as his voice cracks), “When It’s Time to Change, You’ve Got to Rearrange,” channeling its inner Brady, the Food and Drug Administration recently issued a draft guidance entitled, “Deciding When to Submit a 510(k) for a Change to an Existing Device.” The agency is soliciting comments and intends to hold a webinar in late August to further explain its position.  This Bulletin will not repeat, item-by-item, the contents of the voluminous document, which includes appendices and flowcharts. However, we will highlight certain parts of the draft that we believe are particularly noteworthy. We will also offer our observations at the end. More >

When Is a Software Change Really a Change that Requires FDA Review?: When to Submit a 510(k) for a Software Change to an Existing Device
By: Alan G. Minsk 

On the same day the Food and Drug Administration issued its revised draft guidance document on when to submit a new 510(k) premarket notification for an existing medical device, it released a similar document specific to software changes and 510(ks). While the former document has garnered more attention, the latter, “Deciding When to Submit a 510(k) for a Software Change for an Existing Device,” is worthy of review. FDA will accept comments for the guidance. More >

No Idea about UDI: FDA Issues Draft Guidance on UDI Form and Content
By: Alan G. Minsk and Elizabeth A. Mulkey

In advance of the September compliance date for Class II medical devices, the Food and Drug Administration has issued draft guidance on the form and content of Unique Device Identifiers (UDIs). Though the UDI Rule was finalized in September 2013, FDA intends this guidance to help clarify the Rule’s requirements and “ensure the UDIs developed under systems for the issuance of UDIs are in compliance with the Rule.” More >



FTC Establishes a Low Bar for Consumer Harm in Data Security Cases: Finds LabMD Engaged in Unfair Practices
By: Kevin Coy

On July 29, 2016, the Federal Trade Commission (FTC or “the Commission”) issued an important opinion in its long-running data security case against LabMD, finding that the company engaged in unfair practices in violation of Section 5 of the Federal Trade Commission Act (FTC Act) as a result of poor data security practices. In doing so, the Commission took an expansive view of what constitutes consumer harm in data security unfairness cases, finding that the unauthorized disclosure of sensitive health and medical information by itself constitutes a substantial injury. While health and medical information was at issue in the LabMD case, the FTC could also seek to apply the same principle to other types of sensitive data. More >

Federal Jury Convicts Two Former Acclarent, Inc. Executives on Misdemeanor Charges Related to Off-Label Marketing of Medical Device; Acquits on Felony Charges
By: Sara M. Lord and Kara B. Gordon

On July 21, 2016, two former executives of Acclarent, Inc., a medical device company owned by Johnson & Johnson, Inc., were found guilty of ten misdemeanor violations of the Federal Food, Drug and Cosmetic Act (FDCA), following a six-week jury trial in Boston. The former executives were acquitted on fourteen felony counts, including conspiracy, securities fraud, wire fraud, and violations of the FDCA. The charges against the former executives, former Chief Executive Officer William Facteau and former Vice President of Sales Patrick Fabian, stemmed from Acclarent’s marketing of its sinus spacer product as a steroid delivery device without U.S. Food and Drug Administration approval. More >

Industry Activities and Recognition 

Best Lawyers Recognizes 34 Arnall Golden Gregory Attorneys for Providing Exceptional Service

The leading rankings service Best Lawyers® recognizes 34 Arnall Golden Gregory lawyers as exceptional practitioners in the newly released 2017 rankings. The recognition includes a broad swath of AGG practices, including Healthcare, Litigation, Real Estate, Corporate, Immigration, Trust and Estates, Tax, and FDA.

Upcoming Events

AGG Partner Alan Minsk will participate on two panels at the RAPS Annual Meeting in San Jose, California on September 19-20, 2016. On one panel, he will discuss recent court developments relating to off-label promotion by pharmaceutical and medical device companies; for the second panel, he will discuss potential individual liability issues that senior management must consider if involved in non-compliance.

AGG Partner Alan Minsk will speak at the Prescription Drug Marketing Act (PDMA) Alliance Annual Conference on September 21, 2016, in Chantilly, VA. Mr. Minsk’s presentation will focus on compliance with speaker agreements.

AGG Partner Alan Minsk will co-present at the 28th FDA Boot Camp in Boston, Massachusetts on September 22, 2016, regarding the basics of FDA’s drug and biologic labeling and promotional requirements.

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.
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