Search Results (539)
Documents on Antitrust & Trade Regulation, Health Care
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|FTC and DOJ Hold Workshop on Health Care Payment Models and Effects on Competition|
Whitney Magee Phelps; Greenberg Traurig, LLP;
March 4, 2015, previously published on February 27, 2015Health 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...
|Ninth Circuit Affirms Finding That Hospital’s Acquisition of Medical Group Was Anticompetitive|
Robert B. Craig; Taft Stettinius & Hollister LLP;
March 2, 2015, previously published on February 12, 2015The 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...
|FTC 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.;
February 26, 2015, previously published on January 26, 2015Last 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...
|FDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities|
Duane Morris LLP;
February 26, 2015, previously published on December 9, 2014On 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:
|Australian Antitrust Enforcement Focuses on Healthcare & Life Sciences|
Jason A. Beer, Stella Lee, Bevin M.B. Newman, Nick Taylor; Jones Day;
February 25, 2015, previously published on December 2014The 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.
|The Department of Health and Human Services Proposes Tougher Reporting Rules in a Bid to Increase Clinical Trial Transparency|
Scott S. Liebman; Loeb & Loeb LLP;
February 25, 2015, previously published on November 2014The 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.
|Summary of Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc., 2014-1391|
Yoonhee Kim; Sughrue Mion PLLC;
February 17, 2015, previously published on December 3, 2014On 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...
|Federal 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;
January 16, 2015, previously published on October 29, 2014In 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...
|Antitrust Alert: Jury Finds for Drug Manufacturers in First Post-Actavis "Reverse Payment" Trial|
Jonathan Berman, Benjamin Cheng, Aimee DeFilippo, Kevin McDonald; Jones Day;
January 8, 2015, previously published on December 24, 2014In 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...
|FDA 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;
December 16, 2014, previously published on November 2014Cybersecurity 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...