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Documents on Antitrust & Trade Regulation, Health Care

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HTMLFTC and DOJ Hold Workshop on Health Care Payment Models and Effects on Competition
Whitney Magee Phelps; Greenberg Traurig, LLP;
Legal Alert/Article
March 4, 2015, previously published on February 27, 2015
Health care is the single largest industry in the United States with expenses comprising 18 percent of the gross domestic product. Costs need to be controlled while maintaining and improving the quality of care provided. This can be accomplished either through competition or regulation. In addition...


HTMLNinth Circuit Affirms Finding That Hospital’s Acquisition of Medical Group Was Anticompetitive
Robert B. Craig; Taft Stettinius & Hollister LLP;
Legal Alert/Article
March 2, 2015, previously published on February 12, 2015
The Federal Trade Commission maintained its winning streak in health care merger cases after the 9th Circuit affirmed an Idaho district court’s ruling that the acquisition of Idaho’s largest physician group by one of the state’s largest health care systems violated Section 7 of...


HTMLFTC and DOJ to Host Second Public Workshop on Health Care Competition
Farrah Short, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
February 26, 2015, previously published on January 26, 2015
Last March, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) began a public workshop series entitled, “Examining Health Care Competition.” On February 24 and 25, 2015, the FTC will physically host the second workshop in this series, co-hosted again by the Antitrust...


HTMLFDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities
Duane Morris LLP;
Legal Alert/Article
February 26, 2015, previously published on December 9, 2014
On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities. These documents include:


HTMLAustralian Antitrust Enforcement Focuses on Healthcare & Life Sciences
Jason A. Beer, Stella Lee, Bevin M.B. Newman, Nick Taylor; Jones Day;
Legal Alert/Article
February 25, 2015, previously published on December 2014
The Australian Competition and Consumer Commission (ACCC) has continued its focus on the healthcare and life sciences sectors this year, most recently commencing litigation against Little Company of Mary Health Care, operator of Calvary Health (Calvary), a major Australian healthcare provider.


HTMLThe Department of Health and Human Services Proposes Tougher Reporting Rules in a Bid to Increase Clinical Trial Transparency
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 2014
The DHHS is seeking to expand the scope of information on clinical trials that must be submitted to the NIH’s online data set of experiments in the midst of ongoing concerns that too many trial results are withheld.


HTMLSummary of Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc., 2014-1391
Yoonhee Kim; Sughrue Mion PLLC;
Legal Alert/Article
February 17, 2015, previously published on December 3, 2014
On December 3, 2014, in Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc., the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) vacated the district court’s judgment of invalidity, holding that the district erred in determining inherency in the context of...


HTMLFederal Judge Rules That Integrated Healthcare System Comprised of Separately Owned Hospitals Incapable of Conspiring Under Section One of The Sherman Act
Robert B. Craig; Taft Stettinius & Hollister LLP;
Legal Alert/Article
January 16, 2015, previously published on October 29, 2014
In recent years, some competing hospital systems have achieved the benefits of merging without a change in ownership of their assets by undertaking highly integrated joint ventures so that the combination essentially becomes a single enterprise with a complete unity of interest. Such “virtual...


HTMLAntitrust Alert: Jury Finds for Drug Manufacturers in First Post-Actavis "Reverse Payment" Trial
Jonathan Berman, Benjamin Cheng, Aimee DeFilippo, Kevin McDonald; Jones Day;
Legal Alert/Article
January 8, 2015, previously published on December 24, 2014
In the first "reverse payment" trial since the U.S. Supreme Court’s Actavis decision held that "reverse payment" settlements potentially could be found anticompetitive under a rule of reason analysis, a federal jury in Massachusetts has returned a verdict in favor of the...


HTMLFDA Voices Privacy Concerns and Promotes Medical Device Cybersecurity with New Guidance, Collaborative Information-Sharing
Laurie A. Clarke, Alexis Slagle Gilroy, Colleen Heisey, Kevin D. Lyles, Mauricio F. Paez; Jones Day;
Legal Alert/Article
December 16, 2014, previously published on November 2014
Cybersecurity of medical devices poses unique challenges for industry and regulators, because of potential risks in device malfunction, disruption of medical care, and compromised patient data, as well as the challenge of balancing countervailing needs, such as patient safety and ensuring that...


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