Washington Legal Foundation hosted a Web Seminar program yesterday, Physician Payments in the “Sunshine”: Implications of CMS Regulations for Businesses and the Future of American Health Care.
Speakers James Stansel and Meenakshi Datta of Sidley Austin LLP delved into the complicated and often vague data collection and reporting mandates required under the Physician Payment Sunshine Act and the regulations promulgated to implement it. They paid particular attention to how the mandates will impact research and development of new drugs, biologics, and medical devices, processes where physicians play an integral role.
The program is available as an on-demand file by clicking on the title above.
Click here for the slides our speakers utilized.
During the program, it was mentioned that WLF would be filing comments with CMS on the First Amendment problems with the Sunshine Act rules failing to exempt the sharing of medical textbooks and chapters of textbooks with doctors and teaching hospitals. Those comments can be downloaded here.
At a February 21 WLF Web Seminar, Sustainable “Green Advertising”: Implications of FTC’s Guidelines for Public, Private, and Self-Regulation, two private attorneys and a forestry trade association environmental expert offered a revealing tour through the provisions and pitfalls of the Federal Trade Commission’s (FTC) guidelines for “green advertising.” The Commission issued the third edition of its “Green Guides” in October 2012. The Guides inform FTC’s use of its “unfair advertising” authority under Section 5 of the FTC Act and are also specifically incorporated by reference in numerous state consumer protection acts, most prominently California’s.
The presenters at this hour-long program, which can be viewed for free by clicking the title above, were Crowell & Moring partner Christopher Cole and associate Natalia Medley, along with American Forest & Paper Association Senior Director of Energy and Environmental Policy Jerry Schwartz.
The speakers organized their remarks with a Powerpoint presentation, which is available visually to those who view the program. The slide deck is also available here.
Some of the interesting insights that you will hear from our speakers include:
- Products which may meet the thresholds required under federal environmental regulations to qualify as “non-toxic” may not be marketed as such under the Green Guides if trace amounts of toxic materials are present.
- The marketing of products as “non-toxic” or “free of” certain substances will likely be two of the most challenged practices under the guides. Those challenges will most likely be brought by companies against other companies, especially larger companies vs. smaller companies.
- The concept of “recycled content” was one of the most hotly contested during debate and discussion leading to the finalization of the Guides. For instance, textile and paper companies which utilize scraps of materials generated from production in further production cannot claim such products were made with “recycled content” because in the FTC’s mind, such usage is a routine industry practice.
- Class action plaintiffs’ lawyers might use the Green Guides as a baseline for filing private shareholder class action lawsuits challenging public companies’ “sustainability reports”.
Before fully moving forward into 2013, The Legal Pulse offers five late December developments our readers may have missed during the holiday season:
1. Administration’s Regulatory Plan Released. The federal government waited until late December to release its Spring 2012 Unified Agenda of Regulatory and Deregulatory Actions. This is the list of regulatory plans that the Office of Information and Regulatory Affairs at the Office of Management and Budget requires all federal agencies to submit to it by April of each year. As noted by the House Oversight Committee, the Unified Agenda has traditionally been issued between April and July. We’re in the process of reviewing it, but one item from the EPA’s priorities list jumped off the screen: “Expanding the Conversation on Environmentalism and Working for Environmental Justice.” We’ve consistently raised red flags about environmental justice here at The Legal Pulse, and will keep an even closer eye on that going forward.
2. FTC Issues Report on “Child-Directed” Food Advertising. What a difference a year makes. At the end of 2011, we were still talking about the threat posed to free speech and freedom of choice by the Interagency Working Group’s (IWG) Nutrition Principles to Guide Industry Self-Regulatory Efforts. As that Legal Pulse post explained, Congress all-but terminated that effort by requiring a cost-benefit analysis. Last March, FTC Chairman Leibowitz told a congressional panel that it was “time to move on” from the IWG “self-regulatory” effort.On December 21, the Commission released what it termed a “follow-up” study on food ads directed at children. FTC’s study credited the food industry for expanding its self-regulatory efforts, but remained critical of the amount of money devoted to advertising foods the FTC deemed less-than-nutritious. The study has one major flaw: it is based on data that is three years old. It’s fair to say that a significant amount of improvement in the nutritional value of foods has occurred in those three years. Continue reading
Off-Label Speech After U.S. v. Caronia: Implications for Drug & Device Regulation and the First Amendment, a Washington Legal Foundation Web Seminar program, is now available for on-demand viewing.
Our program featured analysis and commentary from Coleen Klasmeier of the Sidley Austin law firm and WLF’s Chief Counsel, Richard Samp. Coleen and Rich make reference to a Powerpoint slide deck, which due to a technical problem wasn’t available to viewers during the program. The slide deck can be downloaded here.
For her presentation, Coleen coined the term “Sorrellonia” because the U.S. Court of Appeals for the Second Circuit two-judge majority in Caronia became the first court to fully apply the holding and rationale of the U.S. Supreme Court’s 2011 Sorrell v. IMS Health opinion.
Coleen’s and Rich’s presentations drew upon their combined years of experience in dealing with FDA’s application of its off-label speech restrictions and the Justice Department’s prosecution of cases where criminal violations of those rules allegedly occurred.
While they both saw great promise in the opinion for greater freedom in the exchange of critical medical information, they also offered firm notes of caution that the ruling not be interpreted as a green light for businesses’ promotion of off-label uses. Great peril still exists in this area they warned, a fact that is all the more apparent today with the announcement of another nearly $1 billion Justice Department settlement with a pharmaceutical company.
Katie Owens, a 2012 Judge K.K. Legett Fellow at the Washington Legal Foundation and a student at Texas Tech School of Law.
On June 4, 2012, the California Court of Appeal for the Second District issued a decision of great interest to businesses, upholding the use of class action waivers in employment arbitration agreements.
In Iskanian v. CLS Transportation Los Angeles, LLC the plaintiff, Arshavir Iskanian, was a driver for defendant CLS from March 2004 to August 2005. As part of his employment, Iskanian signed a “Proprietary Information and Arbitration Policy/Agreement,” an arbitration agreement providing that “any and all claims” arising from his employment be submitted to binding arbitration before a neutral arbitrator. In August 2006, Iskanian filed a class action complaint against CLS alleging several causes of action under California’s Labor Code and Unfair Competition Law, including failure to pay overtime, provide meal and rest breaks, and reimburse business expenses. CLS filed a motion to compel arbitration under the agreement signed by Iskanian, but then later withdrew it. The parties then proceeded to litigate the case.
Applying the California Supreme Court’s standard from Gentry v. Superior Court, where under certain circumstances a class waiver “would impermissibly interfere with employees’ ability to vindicate unwaivable rights and to enforce the overtime laws,” the trial court granted Iskanian’s motion to certify the case as a class action. Continue reading
Bloomberg Businessweek published an article yesterday with the hopeful title, Consumers May See New Limits on Mandatory Arbitration. The article parroted and quoted the perspectives of activists and former government regulators like Elizabeth Warren and Public Citizen’s Deepak Gupta that arbitration is deeply unfair to consumers and deprives them of their day in court.
For another view on how arbitration clause challenges have fared in court in federal agencies, we encourage you to view Washington Legal Foundation’s Web Seminar program, Arbitration after AT&T Mobility v. Concepcion: Judicial, Regulatory, and Strategic Legal Responses to High Court’s 2011 Ruling. Mayer Brown LLP partners Andy Pincus and Evan Tager, who argued on behalf of AT&T Mobility in the case in the Supreme Court and in the Ninth Circuit, respectively, were our speakers.
This hour-long program requires free registration, and the video and audio broadcast must be viewed using Internet Explorer.
Can the Supreme Court, Congress, or anyone provide an “endgame” to the federal government’s highly lucrative, and at time ludicrous, enforcement efforts against medical device and pharmaceutical companies’ speech about “off-label” uses of their products? This was the subject of an insightful hour-long WLF Web Seminar program today.
ENDGAME?: The Solution to Drug and Device Makers’ Off-Label Problem featured two attorneys who businesses regularly call on when the Food and Drug Administration, federal prosecutors, or private whistleblowers register concerns over so-called off-label promotion, Dr. Paul Kalb and Coleen Klasmeier. Dr. Kalb and Ms. Klasmeier organized their presentation around a PowerPoint presentation, which can be downloaded here.
During the presentation, Ms. Klasmeier discusses one possible “endgame” solution, which she explores in a forthcoming Working Paper, FDA Regulation of Off-Label Promotion: An Answer.
Now available online is the archived video of a Media Nosh program WLF sponsored yesterday, Self-Regulation of Advertising: The Merits of Voluntary Action and Creeping Risks of Government Intrusion.
Director of the Children’s Food and Beverage Advertising Initiative, Elaine Kolish; McDermott, Will & Emery counsel and former Beer Institute general counsel Arthur DeCelle; and Reed Smith partner John Feldman participated in the event.
Food Navigator USA did a report on the event focused on Ms. Kolish’s comments.
The following materials were made available to the attendees:
In case you missed it, a video of WLF’s October 26 Web Seminar program, Liability & Exclusion Without Intent: Managing to Survive Under the Responsible Corporate Officer Doctrine, is now available for your on-demand viewing.
The speakers, Mark Calloway and Brian Stimson of Alston & Bird, prepared a PowerPoint presentation to go along with their talk. That presentation is available here.
Constitutional Protection Amidst Severe Civil Punishments, WLF Legal Opinion Letter
“Responsible Corporate Officer”: Business Executives Face Strict Liability Under Novel Criminal Law Doctrine, WLF Legal Backgrounder