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August 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


One Thing Leads to Another: FDA Enforcement in One Area Bleeds into a Second
By: Alan G. Minsk and Kelley Coleman Nduom

FDA recently issued a Warning Letter to a company, primarily for violations of current Good Manufacturing Practice requirements, in which the agency also noted that the company was marketing unapproved prescription drugs. The letter is consistent with the agency’s guidance in its 2011 "Marketed Unapproved Drugs -- Compliance Policy Guide," where the agency stated that it would prioritize enforcement against “unapproved drugs that are also violative of the Act in other ways,” and it serves as a reminder that FDA remains concerned about the continued sale of unapproved new drugs.More >

Wyeth Pharmaceuticals Will Pay $490.9 Million for Marketing the Prescription Drug Rapamune for Unapproved Uses
By: Sara M. Lord

On July 30, 2013, the Justice Department and the Department of Health and Human Services Office of the Inspector General announced that Wyeth Pharmaceuticals Inc. will pay $490.9 million to settle criminal and civil claims arising from the unlawful marketing of the prescription drug Rapamune. In 1999, Wyeth received approval from the Food and Drug Administration to market Rapamune, an immunosuppressive drug that prevents the body’s immune system from rejecting a transplanted organ, for use in renal (kidney) transplant patients. The criminal and civil settlements each address Wyeth’s promotion of the drug for unapproved use in non-renal transplant patients. More >

Bad Data In, Bad Data Out? FDA Issues a Warning Letter Against a Clinical Trial Investigator
By: Alan G. Minsk and Sari N. Bourne

In June 2013, the Food and Drug Administration (FDA) issued a Warning Letter to a clinical trial investigator for not complying with applicable requirements governing clinical investigations and the protection of human subjects. The Warning Letter serves as a reminder of FDA’s enforcement authority and a wake-up call to sponsors that rely on investigators to conduct studies that may be used to support marketing applications.More >



Medical Devices

FDA Draft Guidance Clarifies Medical Device Reporting for Manufacturers
By: Emalee G. Murphy

For medical device manufacturers puzzled over FDA reporting and recordkeeping requirements, the draft guidance issued on July 11, 2013 will come as a welcome insight into FDA’s current thinking on this issue and will provide some practical advice for completing medical device reports submitted to the agency in regard to certain device-related adverse events. More >



Senate Committee Scrutinizes Energy Drink Marketing to Youth and Social Media Tactics
By: Emalee G. MurphyKelley Coleman Nduom and Sari N. Bourne

On July 31, the U.S. Senate Committee on Commerce, Science, and Transportation held a hearing entitled “Energy Drinks: Exploring Concerns about Marketing to Youth.” The hearing was prompted by continuing concerns that energy drinks pose health risks to teenagers due to their caffeine content. More > 

AGG Attorneys Co-Author Book Chapter on FDA Inspection and Enforcement

William H. Kitchens and Alan G. Minsk co-authored a book chapter entitled "FDA Inspection and Enforcement" for Fundamentals of U.S. Regulatory Affairs (Eighth Edition), published by the Regulatory Affairs Professionals Society. The book is well-suited to professionals new to U.S. regulatory affairs or those looking for a reference on FDA regulatory requirements, processes, and policies. It is used as a training tool at many prominent healthcare organizations and universities. More > 

William Kitchens Enters 34th Year of Teaching at Emory University School of Law

William H. Kitchens, who advises companies in the food, medical device, pharmaceutical and biotech industries, began serving as an adjunct professor at Emory University’s School of Law in 1979. August 20 marks his 34th year of teaching food and drug law. 

Upcoming Events

Alan Minsk to Present "Maximize FDA Compliance When Using Social Media" to Regulatory Affairs Professional Society - Atlanta Chapter on September 12, 2013

Emalee G. Murphy to Moderate "Top Cases of 2012 and 2013: The Changing Legal Environment" at The Food and Drug Law Institute's Advertising & Promotion Conference on September 17, 2013

Alan Minsk and Kelley Nduom to Present "Drugs and Biologics: Labeling" at the American Conference Institute's FDA Boot Camp on September 17, 2013

Alan Minsk to Present "State Issues: A Discussion of State-Specific Regulations and Compliance Strategies" at the 2013 PDMA Sharing Conference on September 29, 2013

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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