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Documents on Antitrust & Trade Regulation, Health Care
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|FDA Indicates Shared Nonproprietary Names Not Appropriate for All Biological Products, Including Biosimilars|
Edgar J. Asebey, Maureen Bennett, Colleen Heisey, Janet M. McNicholas, Christian Paul; Jones Day;
September 11, 2015, previously published on September 2015On August 28, 2015, the U.S. Food & Drug Administration ("FDA") released a draft guidance document describing its current position on biological product nonproprietary naming, including the need for biological products to bear a nonproprietary name to which is attached an...
|FDA Issues Guidance on Leveraging Adult Clinical Data to Support Marketing Approval and Labeling of Pediatric Devices|
Scott S. Liebman; Loeb & Loeb LLP;
June 16, 2015, previously published on May 2015The regulator is looking to remedy a lack of available scientific evidence to support pediatric device indications in PMA applications and HDEs by encouraging the extrapolation from existing clinical data, hoping the approach will streamline the requirements for establishing a pediatric intended...
|FDA to Consider Patient Preference Data During Decision-Making for Devices under PMA, HDE or De Novo Review|
Scott S. Liebman; Loeb & Loeb LLP;
June 16, 2015, previously published on May 2015The agency issued draft guidance on submitting patient preference information as part of PMA and HDE applications and de novo requests, as well as on incorporating the data in labeling, saying patient perspectives can be important to take into consideration when making benefit-risk determinations.
|A Split FTC Accepts Fix-It-First Divestiture Remedy for Cigarette Merger|
Farrah Short, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
June 16, 2015, previously published on May 28, 2015The Federal Trade Commission (“FTC”) accepted on Tuesday from Reynolds American Inc. (“Reynolds”) and Lorillard Inc. (“Lorillard”), subject to final approval, a Consent Order settling the agency’s significant competitive concerns with Reynolds’s...
|Injunction Blocks Implementation of Texas Telemedicine Regulations|
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
June 16, 2015, previously published on June 4, 2015Late last week, Texas telemedicine practitioners received a temporary reprieve from a new regulation issued by the Texas Medical Board (the “Board”) when a Texas federal court prohibited implementation of the new rule that would have prevented prescribing via telemedicine. The...
|FTC Says New York’s Medicaid Redesign Program May Promote Anticompetitive Behavior|
Dionne C. Lomax, Stephen M. Weiner, Nili S. Yolin; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
May 14, 2015, previously published on May 4, 2015In an April 22, 2015 letter to the New York State Department of Health (DOH), the Federal Trade Commission (FTC) cautioned that part of the State’s Medicaid reform program may sanction anticompetitive behavior. The FTC’s concern stems from the Certificate of Public Advantage (COPA)...
|FTC Flushes McWane in a Big Eleventh Circuit Exclusive Dealing Win|
Helen J. Kim, Timothy J. Slattery, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
May 6, 2015, previously published on April 22, 2015The situations where exclusive dealing policies, explicit or tied to an aggressive discounting program, cross the line under the rule-of-reason remain far from clear. Because it involved appellate review of a Federal Trade Commission (“FTC” or the “Commission”) ruling...
|FTC Settles Radioactive Allegations Against Cardinal Health with a Near Record-Breaking Disgorgement Agreement|
Helen J. Kim, Dionne C. Lomax, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
May 6, 2015, previously published on April 21, 2015In a 3-2 decision, as part of its aggressive antitrust enforcement in health care industries, the Federal Trade Commission (FTC or the Commission) announced that Cardinal Health, Inc. (Cardinal) agreed to pay $26.8 million to resolve the FTC’s allegations that Cardinal illegally monopolized...
|Hospital Wins First Round Against Largest Rival in Antitrust Suit Alleging Illegal Exclusive Dealing Agreements with Insurers|
Robert G. Kidwell, Dionne C. Lomax, Farrah Short, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
April 6, 2015, previously published on March 30, 2015The waves of change affecting health care providers include reimbursement and funding developments, the impact of the Affordable Care Act, technological and medical advances, provider network design transformations imposed by payors — and antitrust. The Federal Trade Commission’s...
|FTC Tastes Sweet Victory in POM Wonderful Deceptive Advertising Appeal|
Timothy J. Slattery; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
March 30, 2015, previously published on February 17, 2015The District of Columbia Circuit Court of Appeals handed the Federal Trade Commission a critical win on January 30, 2015 by affirming the Commission’s January 2013 decision holding POM Wonderful LLC in violation of the FTC Act for its deceptive advertisements alleging pomegranate juice and...