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   March 2017

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 Is Cold As Ice As It Steps Up Foreign Inspection Enforcement 
Alan G. Minsk 

So far, in 2017, the Food and Drug Administration’s Office of Manufacturing Quality in the Center for Drug Evaluation and Research has released twelve Warning Letters. Of these, 100% involved manufacturing facilities outside the United States; six to Chinese sites, one to a British firm, one to an Italian facility, two to Indian companies, and two to Japanese locations. While it is too early in the year to assess whether this reflects an increased FDA focus on foreign inspections, companies should take note if they have manufacturing sites outside of the U.S. or utilize contract manufacturers in other countries. 
More >

Let the Sunshine In: Increased Transparency Coming to FDA Advisory Committees
By: Alan G. Minsk and Kalie E. Richardson

Spurred by a challenge from Public Citizen last year, the Food and Drug Administration announced recently that it will no longer redact information from the curricula vitae (CV) of advisory committee members. Current advisory committee members must send updated CVs to FDA, along with an acknowledgment that information in their CV has not been redacted. This shift in policy is a win for advocates who have pushed for transparency of FDA’s decision-making process.
 More > 



Expansion of the Humanitarian Use Device Program under the 21st Century Cures Act 
By: Alan G. Minsk and Kalie E. Richardson

The 21st Century Cures Act, signed into law in December 2016, ushered in a number of changes that will affect the Food and Drug Administration’s product development programs. One such example relates to the expansion of the FDA’s Humanitarian Use Device Program (HUD Program). More >



2017 HIPAA Enforcement: Year to Date Lessons
By: Kevin Coy and Madison M. Pool

With the announcements from OCR of three resolution agreements and one civil money penalty as of mid-February, OCR is off to a record start for HIPAA enforcement in 2017, with double the announcements as the same time last year. Notably, this swift initial series of HIPAA enforcement actions has been announced following—and foreshadows rivaling—what was also a record-setting year for OCR enforcement in 2016. Based on the announcements thus far this year, OCR appears to be continuing its focus on compliance with the HIPAA Security Rule and protection for electronic protected health information (“ePHI”). Covered entities and business associates alike should heed the lessons learned from these announcements and take steps to review their HIPAA compliance and bolster it as necessary. More >

Industry Activities and Recognition 

Bill Kitchens Quoted in Food Industry Cover Article

AGG Senior Counsel William H. Kitchens was quoted extensively in the cover article in the January/February issue of Frozen & Refrigerated Buyer magazine concerning the legal issues surrounding sales calls between buyers and sellers in the food industry. More >

Upcoming Events 

AGG Partner Alan Minsk will present “Drugs and Biologics: Labeling” at the American Conference Institute’s 29th FDA Boot Camp on March 23, 2017 in New York, NY.

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.
©2017. Arnall Golden Gregory LLP. All Rights Reserved.  Atlanta | Washington, DC

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