Category Archives: Public Policy

Latest From Public Policy

FDA Acts on Biosimilars


The Biologics Price Competition and Innovation Act (BPCIA) deferred to the Food and Drug Administration with regard to implementing the particulars of how the biosimilar approval pathway would be implemented.  The U.S. Food and Drug Administration has issued a series of draft Guidances indicating how it was considering implementing the biosimilar approval pathway contained in the Act.  The Guidances were expressly “draft” in nature, and were the subject of public hearings with the Agency welcoming Read More >

Patently BIOtech  |  Leave a comment  |  Email This Post
Tags: , , , , , , , , , ,

Rep. Pompeo’s GMO Labeling Bill Receives Broad Support from Lawmakers

public policy

On June 18, 2015, the House of Representatives Energy and Commerce Health subcommittee held a hearing to examine and discuss a national framework for the review and labeling of biotechnology in food. In a release, the Biotechnology Industry Organization (BIO) applauded the House Energy and Commerce Health subcommittee for holding this important hearing and further discussion on the bipartisan Safe and Accurate Food Labeling Act (H.R. 1599). Right now there are 26 states with pending Read More >

Farmer Gene  |  Leave a comment  |  Email This Post
Tags: , , , , , , , , , , , ,

Complexities of Rare Diseases Take the Spotlight at BIO


Global Genes Founder & CEO Nicole Boice opened the BIO 2015 Orphan & Rare Disease Track by addressing a packed session with a simple, powerful statement: “We’re all working to eliminate the challenges of rare diseases, but patients and their advocates aren’t always equipped to fight.” Organizations like Global Genes help families affected by rare disease by connecting them with much needed tools and resources. By better understanding the definition of a “rare” disease, industry Read More >

Business and Investments, Events, Health, Public Policy  |  Leave a comment  |  Email This Post
Tags: , , , , , , , , , , ,

Outdated Payments Systems Aren’t Keeping Pace With Medical Innovation

Ensuring Patient Access to Innovative Medicine

We are experiencing an era of rapid medical progress thanks to the accelerated pace at which new breakthroughs are being uncovered. The compression in time between research and the creation of new treatments is a triumph for patients but a challenge for our outdated healthcare delivery system. Our payment systems were constructed to finance medical costs that increased at predictable rates but are now outdated because of the breakthrough medical advances constantly being made. The Read More >

Events, Health, Public Policy  |  Leave a comment  |  Email This Post
Tags: , , , , , , ,

Biosimilars at the Federal Circuit – Can the Parties Be Compelled to Dance?


In 2009, Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”), which for the first time provided for biosimilar or interchangeable biological drug products.  But it was not until March 6, 2015, that the FDA approved the first biosimilar application – an application by Sandoz to market a version of Amgen’s NEUPOGEN® (filgrastrim) biologic drug product.  Nevertheless, there is still a question as to when Sandoz will be able to begin selling its drug product, Read More >

Patently BIOtech  |  Leave a comment  |  Email This Post
Tags: , , , , , , , , , , , , ,