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 Food and Drug Newsletter    

May 15, 2013


Arnall Golden Gregory LLP's (AGG) 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


And Yet Another Twist in Product Liability Litigation, Preemption and Generic Drug Liability
By: Alan Minsk and Kelley C. Nduom

In Fulgenzi v. PLIVA, the Sixth Circuit ruled against a generic drug manufacturer in the latest installment of cases analyzing preemption of state failure-to-warn claims (6th Cir. No. 12-3504, March 13, 2013). The court attempts to further define preemption and potential product liability claims against generic drug companies and finds that preemption might not apply in certain cases. More >

House Holds Hearing on FDA's Authority over Compounding Pharmacies
By: William K. Kitchens and Emalee G. Murphy 

In light of the 2012 fungal meningitis outbreak, regulation of pharmacy drug compounding has received significant attention. On April 16, 2013 the House Energy and Commerce Subcommittee on Oversight and Investigations heard testimony from FDA Commissioner Margaret A. Hamburg at a hearing entitled “A Continuing Investigation into the Fungal Meningitis Outbreak and Whether It Could Have Been Prevented.” This article summarizes the hearing, the history of FDA’s enforcement against pharmacy compounding, current pharmacy compounding enforcement, and future Congressional action. More >


Medical Devices

FDA Issues Guidance on Medical Device Product Codes
By: William H. Kitchens

The Food and Drug Administration (FDA) announced on Thursday, April 11, 2013, the availability of a guidance document entitled “Medical Device Classification Product Codes.” The guidance, which supersedes the previous device product code guidance document issued in 2012, is intended to describe how classification product codes are used at FDA to regulate, track, and identify medical devices. More >



Governor Brown (CA) Proposes to Shut Down Proposition 65 “Shake-down” Law Suits
By: Emalee G. Murphy

California’s Governor Jerry Brown has proposed reforms to strengthen and restore the intent of the California Safe Drinking Water and Toxic Enforcement Act of 1986, better known by its original name of Proposition 65 and to stop so-called “shake down” law suits brought against personal care, dietary supplement, food, drug, and medical device companies. More >

With Enough Support from Interested Parties, Proposed California Legislation Could Protect Companies from Prop 65 “Bounty Hunters”
By: Emalee G. Murphy

For companies that may be caught in unsuspected Prop 65 violations and for whom the prospect of a disagreeable settlement or an expensive law suit are equally unattractive, the amendment introduced earlier this year by Assemblyman Mike Gatto (D-Los Angeles) may provide a welcome alternative. More >


Legislative Update from Capitol Hill

FTC Releases New Guidance on Online Advertising Disclosures
By: Emalee G. Murphy

The Federal Trade Commission (FTC) recently issued a new guidance document for online advertisers entitled “.Com Disclosures: How to Make Effective Disclosures in Digital Advertising.” An earlier FTC guidance on internet advertising (“Dot Com Disclosures; Information on Online Advertising”) was issued in 2000, but this new guidance specifically addresses smart phones and social media marketing. The new guidance provides advice specific to these advertising platforms including how to make disclosures conspicuous, locating disclosure information, use of hyperlinks, and pop-ups. The new guidance is particularly relevant to advertisers in the pharmaceutical, medical device, cosmetic, and food industries as social media and mobile devices are a growing part of industry marketing. More >

FCPA Compliance Tips for the Pharmaceutical/Medical Device Company’s Compliance Officer
By: Michael E. Burke

The pharmaceutical and medical device industries are extremely vulnerable to Foreign Corrupt Practices Act (“FCPA”) investigations and prosecutions because most companies that research, develop, test or sell pharmaceutical products or medical devices overseas interact with foreign officials on a regular basis. Three years ago, the U.S. Department of Justice indicated that FCPA compliance in the pharmaceutical and medical device industries would be an enforcement priority for the agency. The Department has made good on its word, initiating FCPA-related inquiries of multiple pharmaceutical and medical device companies, and the pace of FCPA inquiries in this area is accelerating. More >


Sunshine Series

Physician Payment Sunshine Act Updates
By: H.Carol Saul, Jennifer Downs Burgar and Lanchi Nguyen Bombalier

In an effort to assist our clients and friends with implementation of the final regulations promulgated pursuant to the Physician Payment Sunshine Act (Section 6002 of the Patient Protection and Affordable Care Act), we are providing updates in a “Sunshine Series” of articles. Our Sunshine Series provides information on the government’s preparations for information collection and publication (and eventual enforcement), practical tips for compliance, interesting nuances in the final regulations, State law preemption, and responses to general-interest questions posed by our clients.

 Upcoming Events

Alan Minsk Presents Tips to Ensure FDA Compliance When Using Social Media on May 21, 2013.

Alan Minsk Presents FDA-Related Considerations for Quality Agreements on May 23, 2013.


This newsletter is published by the 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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