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HTMLFDA Continues to Bolster Regulation of Compounding Pharmacies
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
July 22, 2014, previously published on July 2014
Armed with new authority granted by the Drug Quality and Security Act ("DQSA"), FDA is increasingly using its regulatory powers to enhance oversight of compounding pharmacies. DSQA amended section 503A of the Food, Drug, and Cosmetic Act ("FDCA") to clarify the scope of...

 

HTMLFDA Contemplates Further Revisions to "Off-Label" Drug Marketing Rules and Guidance
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
July 22, 2014, previously published on July 2014
According to recent reports, FDA is reevaluating longstanding policies regarding the marketing of pharmaceutical products for "off-label" uses, such as when a manufacturer promotes an otherwise approved product for an indication, age group, or dosage that has not been approved. As...

 

HTMLPayers, Pension Plans, Pharmacies Ask FDA Not to Give Unique Names to Biosimilars
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
July 22, 2014, previously published on July 2014
Earlier this month, a group of 32 companies and organizations, including health insurers, pharmacies, labor unions, and pension plans, urged FDA not to require distinct names for biosimilar products, explaining that such a policy would undermine the potential cost savings generated by such generic...

 

HTMLWyndham Seeks Immediate Appeal Over FTC Authority To Regulate Data Security While District Court Allows Case To Proceed On Common-Enterprise Theory
Stephen Lilley, Archis A. Parasharami; Mayer Brown LLP;
Legal Alert/Article
July 22, 2014, previously published on July 21, 2014
For the past two years, a federal court in New Jersey has considered important data security issues in the FTC v. Wyndham Worldwide Corp. litigation. Two recent opinions issued by the court now have brought that case back into the news—and made clear that the stakes are as high as ever.

 

HTMLFDA Hosts Webinar Addressing Social Media Draft Guidance
Elizabeth H. Kim, Scott S. Liebman; Loeb Loeb LLP;
Legal Alert/Article
July 21, 2014, previously published on July 2014
The Food and Drug Administration hosted a Social Media Draft Guidance Webinar. The July 10 webinar included summary review of the three draft guidances issued this year to date followed by a brief Q&A. Thomas Abrams, director of the Office of Prescription Drug Promotion and the Center for Drug...

 

HTMLFSIS Proposes New Recordkeeping Requirements for Ground Beef Processors & Retailers
Leslie T. Krasny, Manesh K. Rath, David G. Sarvadi, Brian P. Sylvester; Keller and Heckman LLP;
Legal Alert/Article
July 21, 2014, previously published on July 18, 2014
USDA’s Food Safety and Inspection Service (FSIS) plans to propose a rule, in the coming days, that imposes new recordkeeping requirements on ground beef processor establishments and retail facilities.

 

HTMLFTC Rule Targeting Pharma Licenses Is Upheld by Federal Judge
Jordana Goodman; Sunstein Kann Murphy Timbers LLP;
Legal Alert/Article
July 21, 2014, previously published on June 2014
Last November, the Federal Trade Commission (“FTC”) announced a rule requiring advance notice of proposed exclusive patent license agreements in the pharmaceutical industry that exceed $75.9 million in value. Upon receipt of such a notice, the FTC or the Justice Department may then...

 

HTMLPublic Meeting on Proposed Rules to Change Nutrition Facts Label and Serving Sizes
Melvin S. Drozen, Alissa D. Jijon, Leslie T. Krasny, Evangelia C. Pelonis, Laura Venker; Keller and Heckman LLP;
Legal Alert/Article
July 19, 2014, previously published on July 7, 2014
The Food and Drug Administration (FDA) held a public meeting on June 26, 2014 to discuss the proposed rules to revise the Nutrition Facts label and serving sizes. The meeting featured an overview of the proposed rules by FDA, a panel on stakeholder perspectives with representatives from trade...

 

HTMLBacklash Over Facebook Timeline Experiment Serves as a Reminder: User Expectations Still Trump Fine Print
Jake Romero; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
July 18, 2014, previously published on July 9, 2014
If you are one of the approximately 1.3 billion people who use Facebook, you’ve likely experienced the phenomenon where a single event (like Luiz Suarez biting that Italian guy or pretty much anything involving TSA) manages to raise the ire of a large number of your Facebook friends, causing...

 

HTMLThe Affordable Care Act is Not a Free Pass for Anti-Competitive Mergers
McDonald Hopkins LLC;
Legal Alert/Article
July 18, 2014, previously published on July 9, 2014
While the Affordable Care Act (ACA) incentivizes mergers of hospitals, physician groups, and other providers and facilities, the FTC is scrutinizing mergers that would leave few local healthcare options for patients seeking care close to home in an effort to ensure competition is preserved and...

 


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