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  April 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

     

PHARMACEUTICALS

You Look Marvelous: Just Ask FDA Whether Beauty is in the Eye of the Beholder
By: 
Alan G. Minsk

Many of us remember Billy Crystal’s “You Look Marvelous” one-liner from “Saturday Night Live,” where the comedic routine frequently ended with “It’s better to look good than to feel good.” The Food and Drug Administration has a slightly different take for manufacturers -- it’s ok to promote to look marvelous and to look good, but don’t make any drug-like claims. And FDA seems to really mean it lately. More >


 

MEDICAL DEVICES

FDA and CMS Announce Joint Task Force on LDTs
By: Alan G. Minsk and Alan K. Parver 

The U.S. Food and Drug Administration (FDA) recently announced the formation of an interagency task force with the Centers for Medicare and Medicaid Services (CMS) to address issues relating to the regulation of laboratory-developed tests (LDTs). The announcement follows the issuance of draft guidance by FDA in October 2014 that provides a basic framework for increased oversight of LDTs. The draft guidance, "Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories,” sets the groundwork for the FDA to step up its oversight of LDTs. AGG prepared a Bulletin on the FDA’s LDT draft guidance, which can be accessed here. FDA officials have expressed concern that the volume and types of LTDs have grown significantly, they are often used as a mechanism for market entry of novel tests, and they are now being developed for broad commercial use, among other things.
 More > 

Recent Antitrust Class Actions Related to Contact Lenses
By: Jeffrey S. Jacobovitz and Eric D. Olson

On March 3, 2015, the four largest contact lens manufacturers and a contact lens wholesaler were sued in federal courts based on allegations that they violated federal and state antitrust laws. One of the class action lawsuits, which was filed in federal court in San Francisco, contends that the company defendants and a wholesaler conspired with independent optometrists and ophthalmologists to eliminate low-priced competition from big-box retailers and Internet distributors. According to the complaint, the defendants allegedly accomplished this goal by requiring resellers of contact lenses to charge minimum retail prices through so-called “Unilateral Pricing Policies” (UPPs). This was one of a number of antitrust class actions cases filed against contact lens manufacturers over the last few weeks.
 More >


 

NEWS FROM WASHINGTON

Lawmakers Solicit Public Feedback on Legislation Intended to Expand Patients' Access to Drugs, Devices and Other Treatments
By: Alan K. Parver and Leah Mendelson Stone

On January 27, 2015, the House of Representatives Committee on Energy and Commerce released a discussion draft of a bill entitled, “21st Century Cures Act.” The bill includes several proposals that are intended to expand patients’ access to treatments and promote drug and device development, such as modifying processes at the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), and revising several Medicare coverage and reimbursement requirements. More >

The Supreme Court Issues A Landmark Securities Opinion In Case Against Omnicare
By: Sara M. Lord

On March 24, 2015, the U.S. Supreme Court issued a landmark decision under the Securities Act of 1933 in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund. Section 11 of the Act provides a right of action against an issuer if the registration statement filed in connection with a securities public offering “contained an untrue statement of a material fact” or “omitted to state a material fact required to be stated therein or necessary to make the statements therein not misleading.” 15 U.S.C. § 77k(a). As the Court put it, “Section 11 thus creates two ways to hold issuers liable for the contents of a registration statement—one focusing on what the statement says and the other on what it leaves out. More >


Industry Activities and Recognition 

AGG Partners, Hedy Rubinger, Sara Lord and Neil Hoffman Present at the Executive Pre-Conference of the 2015 National Home Infusion Association Annual Conference & Exposition

Hedy S. RubingerSara M. Lord and Neil W. Hoffman spoke at the Executive Pre-Conference of the 2015 National Home Infusion Association (NHIA) Annual Conference & Exposition held on March 23, 2015 in Phoenix, Arizona. Their panel presentation was entitled “Legal Issues in Home and Specialty Infusion Therapy.” Ms. Rubinger’s topic was “Transactional Issues for Home Infusion Providers,” Ms. Lord’s topic was “The 'Do’s’ and ‘Don’ts’ of Responding to Government Investigations” and Mr. Hoffman’s topic was “340B Drug Pricing Program: Contract Pharmacies and Orphan Drug Exclusion."

AGG Partner Invited to Serve on the Food and Drug Law Journal Editorial Advisory Board

Alan G. Minsk has been invited to serve on the Food and Drug Law Journal Editorial Advisory Board. Mr. Minsk will be responsible for serving as peer reviewer for papers submitted for publication and recommending topics for certain issues for the Food and Drug Law Journal.

AGG Partner, Alan Horowitz, Presented at AMDA Annual Conference

On March 21, 2015, Alan C. Horowitz presented "Avoiding Legal Liability for Prescribing Antipsychotics" at the Society for Post-Acute and Long-Term Care Medicine's (AMDA) annual conference in Louisville, KY. Mr. Horowitz was also a co-presenter with Drs. Lindsey Neal and Patricia Bach in a presentation, "The Health Care Social Media Revolution: Best Practices for Using Social Media to Improve Your Post-Acute/Long-Term Care Practice," where he focused on the legal implications of social media in long term care.


Upcoming Events 

AGG Partners Tenley A. Carp and Jeffrey Y. Lewis will present a complimentary webinar "Doing Business in the US: What Foreign Companies Need to Know About Government Contracts and Civil Litigation" on April 29, 2015.

AGG Partner Alan G. Minsk will present “Examine the Evolving Role and Recent Surge in MSLs in the Industry " at the MSL Training and Field Communication Strategies Conference in Philadelphia, PA on May 19, 2015.

AGG Partner Alan G. Minsk Will present a complimentary webinar "FDA Formal Dispute Resolution Above the Division Level: I Fight Authority, Authority Always Wins (or Does It?)" on May 20, 2015.


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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