Science is Beautiful Blog

Biosimilars in the U.S.– A Myriad of Stakeholders Will Continue to Frame This Important Issue in 2015

Posted by John Kouten, CEO

Jan 12, 2015 7:03:57 PM

Ever since the Biologics and Price Competition and Innovation Act (BPCIA) of 2009 found its way into the Affordable Care Act, various stakeholders have been preparing for the U.S. introduction of these so-called “biosimilars.”

Novartis/Sandoz announced in July 2014 that EP2006 was the first 351(k) application accepted for review by US Food and Drug Administration (FDA), an event that occurred almost four and a half years after passage of the BPCIA.  And on January 7, 2015 the FDA Oncologic Drugs Advisory Committee (ODAC) recommended approval of Novartis/Sandoz’ investigational biosimilar filgrastim in the US. The Committee also recommended approval of the biosimilar for use in all indications included in the referenced product’s (Amgen’s NEUPOGEN®) label.

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Topics: FDA, healthcare reform, biosimilars

Medicare Reform: The Status Quo is Not an Option

Posted by John Kouten, CEO

Jun 16, 2011 3:04:00 PM

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Topics: US pharmaceutical market, healthcare reform, Medicare reform

Healthcare Reform and Pharmaceutical Marketers – Sweethearts?

Posted by John Kouten, CEO

Feb 14, 2011 2:14:00 PM

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Topics: Healthcare communications, healthcare public relations, US pharmaceutical market, biotechnology and medical technology companies, personalized medicine, JFK Communications, healthcare reform

Will Media Report how Ted Kennedy’s Life was Extended through Improved Technology to Fight Brain Cancer? Probably Not

Posted by John Kouten, CEO

Aug 26, 2009 4:47:00 PM

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Topics: Healthcare communications, healthcare public relations, issues management, US pharmaceutical market, biotechnology and medical technology companies, media relations, healthcare reform, global oncology market

Tort Reform Anyone?

Posted by John Kouten, CEO

Aug 4, 2009 1:43:00 PM

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Topics: Healthcare communications, healthcare public relations, issues management, US pharmaceutical market, healthcare reform

The Rhetoric of Healthcare Reform and Healthcare Communications

Posted by Maureen Miller

Jul 31, 2009 1:12:00 PM

Last week, National Public Radio’s show “On the Media” discussed the language being used in the healthcare debate. Frank Luntz, communications consultant for the Republican party, shared tips from “The Language of Healthcare 2009: 10 rules for Stopping the ‘Washington Takeover’ of Healthcare,” a 28-page memo instructing the GOP on the best language to sway public opinion.

Both sides of the debate are utilizing highly potent words: “government takeover,” “rationed medicine,” and “ticking time bomb.”  Now, with little chance of movement until after the recess, politicians and stakeholders on both sides of the aisle have the month of August to continue stoking the heat on the healthcare reform debate.

As public relations professionals, we understand the importance of using language to drive awareness, change perceptions and influence behavior.  Words – beyond their denotations – are the most basic of the tools we use.  

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Topics: Healthcare communications, healthcare public relations, healthcare reform

 

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