The Food and Drug Practice of Arnall Golden Gregory LLP is pleased to bring you this e-alert with timely updates on the issues currently affecting industries regulated by the U.S. Food and Drug Administration (FDA). We hope you find the information in these recent publications and the upcoming events useful.
AGG Client Alerts
Do the New Medical Device Registration Requirements Really Apply to Me?
FDA has changed certain medical device establishment registration and listing requirements in accordance with the Medical Device User Fee Amendments of 2012, signed into law on July 9, 2012, and pursuant to the Food and Drug Administration Safety and Innovation Act. All establishments required to register must pay the medical device user fee. The deadline for medical device registration under the new requirements has been extended to January 31, 2013. For more information, please click here or contact Emalee G. Murphy.
ACRE Publishes Model Guidelines on Physician and Pharmaceutical Industry Interactions
The Association of Clinical Researchers and Educators published model guidelines on physician and pharmaceutical industry interactions entitled, "A Statement of the Relationships between Physicians and Industry." The guidelines include considerations for research, consulting, speaking engagements, CME and travel. For more information, please click here or contact Jennifer D. Burgar.
Pay For Delay Update: Supreme Court Enters the Fray
The day of reckoning, or perhaps vindication, could be approaching for those pharmaceutical companies daring enough to enter into reverse payments agreements to settle their patent litigation with generic challengers. On December 5, 2012, the Supreme Court announced that it had granted certiorari in a case brought by the Federal Trade Commission, and that it would decide what level of antitrust scrutiny should be applied by the courts when reviewing these types of agreements. For more information, please click here or contact Clark G. Sullivan or Allen I. Hirsch.
FDA Announces Public-Private Partnership to Enhance the Development of Regulatory Science for Medical Devices
On December 3, 2012, the Food and Drug Administration announced the formation of the Medical Device Innovation Consortium (MDIC), the first public-private partnership to improve public health through the application of shared knowledge in medical device regulatory science. The MDIC is designed to create a collaborative environment where the industry, non-profit organizations, and government can work together to advance pro-competitive medical device research so that the medical device community can keep pace with the needs of the patients in the United States in a more timely manner. The focus of the MDIC will be on speeding the development, assessment, and review of new medical devices throughout the product life cycle. For more information, please click here or contact William H. Kitchens.
IRS Issues Final Medical Device Excise Tax Regulations and Interim Guidance
On December 5, 2012, the Internal Revenue Service (IRS) published final regulations implementing the new medical device excise tax that device manufacturers and importers must pay on sales beginning January 1, 2013. The IRS issued proposed regulations on the tax on February 7, 2012, as explained in detail in an earlier newsletter article. Accompanying the regulation, the Food and Drug Administration also issued Notice 2012-77, an interim guidance and request for comments concerning the tax. IRS requests comments on the interim guidance by March 29, 2013. For more information, please click here or contact Emalee G. Murphy.
Second Circuit Rules Off-Label Promotion Is Protected Speech
On December 3, 2012, the United States Court of Appeals for the Second Circuit reversed the conviction of a pharmaceutical sales representative, who had been found guilty of promoting off-label uses for a drug product, holding that the conviction violated his First Amendment free speech rights. The 2-1 decision by a three-judge panel of the Second Circuit could potentially affect future government prosecutions in the off-label promotional arena, but it is too early to conclude whether this ruling will have broad applicability and, thus, ultimately slow down off-labeling enforcement by the Department of Justice or the Food and Drug Administration (FDA).2 It is not yet known whether the government will request an en banc rehearing before the entire Second Circuit or appeal the case to the United States Supreme Court. For more information, please click here or contact William H. Kitchens or Alan G. Minsk.
FDA Requests Comments on the Custom Medical Device Exemption
On November 19, 2012, the Food and Drug Administration issued a Federal Register notice indicating that it is currently drafting a policy to implement the custom device exemption requirements, identified in the recently-enacted Food and Drug Administration Safety and Innovation Act. This article summarizes the notice. For more information, please click here or contact Alan G. Minsk.
The NAD Takes on “Natural” Claims
At its October annual conference, the National Advertising Division (NAD) of the Council of Better Business Bureaus (CBBB) featured a discussion on claims such as “natural” and “all-natural.” Based generally on the discussion, this article outlines the potential considerations advertisers must take when making such a claim. For more information, please click here or contact Emalee G. Murphy.
Alan Minsk Selected for Inclusion in the Who’s Who of Life Sciences Lawyers 2013
Congratulations to Alan G. Minsk, who has been selected for inclusion in the International Who’s Who of Life Sciences Lawyers 2013, which is scheduled to come out in February. The booklet is produced by Law Business Research Ltd., based in London. Who’s Who says “Nominees have been selected based upon comprehensive, independent survey work with both general counsel and private practice lawyers worldwide.” For more information, please click here or contact Mr. Minsk.
Three AGG Attorneys Quoted in Article About Off-label Drug Promotion Ruling
The medical device trade paper The Gray Sheet reported on the government’s loss in U.S. v. Caronia and quoted AGG attorneys Sara M. Lord, William H. Kitchens and Alan G. Minsk. The U.S. Court of Appeals for the Second Circuit, in overturning a lower court decision, ruled that the government cannot prosecute pharmaceutical companies for speech promoting lawful, off-label use of an approved drug. Ms. Lord, a former Department of Justice attorney, opined on how the DOJ might respond to the Court of Appeals decision. Mr. Minsk said the government is unlikely to scale back its enforcement actions. Mr. Kitchens stated that the decision might prompt businesses to be more aggressive about fighting back. For more information, please click here or contact Mr. Kitchens, Ms. Lord or Mr. Minsk.
Alan Minsk Reappointed as General Counsel of PDMA Alliance, Inc.
Alan G. Minsk, Leader of AGG's Food and Drug Practice Group, was reappointed as General Counsel of PDMA Alliance, Inc. for the 2013 term. PDMA Alliance, Inc. is an organization dedicated to improving industry understanding of the Prescription Drug Marketing Act. For more information, please click here or contact Mr. Minsk.
Michael E. Burke Recently Held an FCPA Compliance Webinar with Grant Thornton LLP
On Tuesday, January 8, 2013, AGG Partner and past chair of the American Bar Association’s Section of International Law Michael E. Burke helped present a webinar titled "Have the Official FCPA Guidelines Changed Your Business Plans?" which attracted over 250 attendees. For more information, please click here or contact Mr. Burke.
William Kitchens to Participate in Georgia Tech Symposium on “Medical Devices and the FDA—Tips for Researchers” On January 24, 2013, William H. Kitchens will present at the Georgia Tech Research Corporation’s symposium “Medical Devices and the FDA – Tips for Researchers’”. Mr. Kitchens will speak on the legal framework for regulation of medical devices in the U.S. For more information, please click here or contact Mr. Kitchens.
Alan Minsk to Present at the 2nd Annual Medical Communications and the Dissemination of Scientific Information Conference
On February 21, 2013, Alan G. Minsk will present at the 2nd Annual Medical Communications and the Dissemination of Scientific Information Conference in Boston, MA. Mr. Minsk will speak on "Regulatory & Legal Compliance Considerations Surrounding Scientific Information Dissemination". For more information, please click here or contact Mr. Minsk.