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Documents on Antitrust & Trade Regulation, Health Care, Insurance
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|Landmark Decision Confirms FTC Authority to Regulate Privacy and Data Security|
Richard J. Johnson, Mark Mansour, Mauricio F. Paez, Katherine S. Ritchey, Gregory P. Silberman; Jones Day;
April 15, 2014, previously published on April 2014In FTC v. Wyndham Worldwide Corp., No 13-1887, 2014 U.S. Dist. LEXIS 47622 (D.N.J. Apr. 7, 2014)—a case closely watched by privacy and data security professionals across the United States—a federal district court held that the Federal Trade Commission ("FTC") has authority...
|Proposed Federal Legislation Aims to Speed Up DEA’s Scheduling of New Medicines and Approval of DEA Registrations in Certain Circumstances|
John A. Gilbert; Hyman, Phelps & McNamara, P.C.;
April 11, 2014, previously published on April 7, 2014A new bill introduced in Congress, H.R. 4299 (titled “Improving Regulatory Transparency for New Medical Therapies Act”), would significantly streamline the drug scheduling process for new medical therapies and reduce the potential for unnecessary delays in the availability of these...
|Zogenix Sues Massachusetts Over Order Banning ZOHYDRO ER; Alleges Ban is Unconstitutional|
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
April 11, 2014, previously published on April 8, 2014Shortly after Massachusetts Governor Deval Patrick issued a press release on March 27, 2014 announcing a Declaration of Emergency and that the Governor had directed the Massachusetts Department of Public Health (“DPH”) and its Commissioner, Cheryl Bartlett, RN, to take several actions...
|Tri-Agency Health IT Report Issued|
Ellen L. Janos, Kate F. Stewart; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
April 10, 2014, previously published on April 3, 2014Today, the three federal agencies charged with regulating components of health information technology (“Health IT”) issued their long-awaited Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework (the “Report”). The Report seeks to develop a...
|California Proposes Enhanced Prop. 65 Warnings and Possible Online Disclosures - Dietary Supplements and Foods Specially Targeted|
Anthony J. Cortez, James Mattesich, Justin J. Prochnow, Greg Sperla; Greenberg Traurig, LLP;
April 3, 2014, previously published on March 28, 2014The California Office of Environmental Health Hazard Assessment (OEHHA) announced on March 7, 2014, that it is considering implementation of the most significant changes to Prop. 65 regulations in more than two decades. OEHHA has posted the draft regulation and Initial Statement of Reasons on its...
|FTC Check-Up on Health Care Trends Reveals New Competitive Wrinkles|
Helen J. Kim, Farrah Short, Timothy J. Slattery, Shoshana S. Speiser; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
March 28, 2014, previously published on March 27, 2014The Federal Trade Commission (FTC or Commission) recently hosted a workshop exploring trends and innovation in the health care industry that may affect competition, marking at least 10 years since the antitrust agencies formally examined competition issues in the industry. Commissioner...
|FDA Revises Draft Guidance Concerning Distribution of Scientific and Medical Publications for Drug and Device Manufacturers|
Elizabeth H. Kim, Scott S. Liebman; Loeb Loeb LLP;
March 11, 2014, previously published on March 2014Updating policies established in a 2009 Guidance, the Food and Drug Administration (FDA) has released a draft version of a proposed 2014 Guidance addressing the use of medical publications in promoting "off label" uses of approved drugs and devices. The draft 2014 Guidance, announced by...
|FDA Draft Guidance Clarifies Recommendations for Distribution of Scientific and Medical Publications on Off-Label Use|
Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
March 7, 2014, previously published on March 2014FDA has issued draft guidance revising its 2009 guidance on manufacturers' dissemination of "journal articles" and "scientific or medical reference publications" that address unapproved or "off-label" uses of drugs and devices. The new draft guidance broadens the scope...
|The Tipping Point? Consolidation of Medical Practices is good for Patients ... Until it’s not|
Mary K. Marks; Greenberg Traurig, LLP;
March 5, 2014, previously published on February 27, 2014On January 24, 2014, the U.S. District Court in the District of Idaho ruled in favor of the Federal Trade Commission (the “FTC”), the State of Idaho, and competing health plans in their challenge to St. Luke’s Health System Ltd.’s acquisition of Saltzer Medical Group, P.A....
|FTC Continues Antitrust Focus on Health Care Sector With Upcoming Two-Day Health Care Competition Workshop|
Cadwalader Wickersham Taft LLP;
March 3, 2014, previously published on February 21, 2014 The Federal Trade Commission (“FTC”) recently announced that it will be hosting a two-day workshop in Washington, DC on March 20-21 to examine competition issues related to current developments in the U.S. health care industry. According to the FTC’s press release, the goal of...