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  January 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



Is it the Hard Knock Life for the Orphan Drug Industry or Will the Sun Come Out Tomorrow?
Alan G. Minsk

Many of us remember the comic strip-turned Broadway musical turned-movie-turned movie, about little orphan Annie. My 8-year old daughter, Kayla, reminds me every day as she sings (on key), “It’s The Hard Knock Life” and “Tomorrow.” The lyrics, “’stead of treats, we get tricked, ‘stead of kisses, we get kicked,” come to my mind when I read the Food and Drug Administration’s (FDA) “clarification policy” regarding orphan drug exclusivity, published in a Federal Register notice, dated December 23, 2014. While some in industry might have hoped that FDA could change its orphan drug policy in light of a recent court decision challenging the agency’s decision on a particular product, the agency said, in keeping with the holiday season, bah humbug. As will be discussed, FDA said the court decision was case-specific, and its policy remains the same. More >



FDA Announces Comment Opportunity on CDRH Documents
By: Alan G. Minsk and Alan K. Parver

The Food and Drug Administration (FDA) has announced the opening of a docket dedicated to receiving comments on guidance documents that the Center for Devices and Radiological Health (CDRH) intends to publish in fiscal year 2015, as well as for previously-issued guidances that may be in need of revision or withdrawal. While FDA welcomes comments on guidance documents at any time, to ensure consideration under this particular solicitation, comments should be received no later than March 10, 2015. The guidance documents up for review are grouped into categories described in the following legal insight. More >

FDA Releases Draft Guidance on 510(k) Transfers
By: Alan G. Minsk and Alexander B. Foster

On December 19 and 22, 2014, the Food and Drug Administration (FDA) released a draft guidance and a Federal Register notice, respectively, on the transfer of a medical device premarket notification application, commonly referred to as a 510(k). The draft provides guidance to industry on how to notify FDA when a 510(k) marketing clearance is transferred and the procedures to ensure accurate and up-to-date information is included in FDA’s databases. FDA is asking for comments on the draft guidance by March 23, 2015. More >



Hart Scott Rodino Update
By: Jeffrey S. Jacobovitz

On January 15, 2015, the Federal Trade Commission announced its annual revisions to the jurisdictional thresholds in the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”). These changes, which will become effective thirty days after their publication in the Federal Register, increase the dollar thresholds to prompt the HSR Act’s premerger reporting requirements. Under the HSR Act, parties involved in certain proposed transactions, including mergers, asset acquisitions and acquisitions of voting securities, must notify the FTC and the Antitrust Division of the Department of Justice if the size of the parties involved and the value of the transaction exceed a certain threshold, absent an exemption. These thresholds are revised annually based on the change in gross national product. More >

Industry Activities and Recognition

Alan Horowitz Publishes Article on Personal Resident Alarms: More Protection or More Risk?

Alan C. Horowitz's article entitled "Personal Resident Alarms: More Protection or More Risk?” was published in the December 2014 edition of Long Term Living Magazine, detailing the potential risks with bed and chair alarms in nursing homes. More >

Michael Burke Launches Irish Export Insights Blog

Michael E. Burke launched a blog entitled "Irish Export Insights: Practical Guidance for Irish and Northern Irish Companies on Doing Business in the U.S." The purpose of this blog is to help Irish and Northern Irish companies understand and mitigate the potential operational risk of exporting or expanding to the U.S. More >

Upcoming Events 

AGG AGG Partners, Neil W. Hoffman and Alan G. Minsk, will present a complimentary webinar “Not Business as Usual: The Ramifications of Orphan Drug Court Rulings in 2014 and a Look to 2015” on January 29, 2015.

AGG Partner, Alan G. Minsk, will present “West vs. East in 2015: Challenges, Trends and Differences and Suggested Models Investments, Joint Ventures, Strategic Partnering and Distribution” at the 3rd International Partnering of the Israeli BioMed Tech Industry − Life Sciences Israel 2015 on February 18-19, 2015.

AGG Partner, Alan G. Minsk, will present “Compliance – It’s the Law and it’s Good Business” at the 39th International Good Manufacturing Practices Conference on March 12, 2015 in Atlanta, GA.

AGG Partner, Alan G. Minsk, will present “Drugs and Biologics: Labeling” at the American Conference Institute FDA Boot Camp on March 10, 2015 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.
©2015. Arnall Golden Gregory LLP. All Rights Reserved.  Atlanta | Washington, DC

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