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Documents on Antitrust & Trade Regulation, Pharmaceuticals, Health Care
 

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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.

 

HTMLIn An Unusual Move, The FDA Takes Issue With The Accuracy Of Sciecure’s Studies In A Warning Letter Over Sales Promotion Material For The Company’s Sleeping Pill
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 2014
In addition to criticizing the pharmaceutical company for leaving out risk information from its sales materials and making unsupported superiority claims, the regulator unusually disputed the accuracy of the sources Sciecure used to bolster its assertions.

 

HTMLFDA Proposes Three Studies on Direct-To-Consumer Prescription Drug Ads in a Bid to Better Understand the Impact of Ad Exposure Frequency, Spousal Influence and Risk Understanding
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 2014
The agency announced three proposed studies on how people view direct-to-consumer advertising, as it continues to assess factors that influence assessments of risks and benefits in a bid to ensure its regulations adequately protect public health.

 

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.

 

HTMLOffice of Inspector General’s 2015 Work Plan Shows Agency Will Examine Medical Device Security, FDA’s Regulation
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 2014
The Department of Health and Human Services’ watchdog agency released a 2015 work plan that calls for federal auditors to assess medical device cybersecurity amid intensifying scrutiny in the area, as well as areas that may be in need of some revamping by the FDA.

 

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...

 


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