Washington, DC (March 5, 2014) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood issued the following statement in response to President Obama’s FY 2015 budget proposal:Continue reading
2013 will soon take its place in the history books with fireworks and strains of Auld Lang Syne.
As 2014 approaches, let’s look into our crystal ball for some predictions of what the new year may have in store…Continue reading
The Federal Trade Commission (FTC) is seeking public comment on follow-on biologics.
- Press Release (November 8, 2013)
- Federal Register Notice (November 8, 2013)
- Filing a Public Comment (Deadline March 1, 2014)
In addition, the FTC will hold a public workshop on December 1oth.
The Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition
The Federal Trade Commission announces it will hold a workshop to explore competition issues involving biologic medicines and follow-on biologics. As described in the Federal Register Notice, the workshop will focus on a few key issues, inter alia:
- The potential impact of state regulations affecting competition.
- How regulations, if necessary, might be structured to facilitate competition while still protecting patient health and safety.
- How naming may affect competition.
- The experience of other countries with follow-on biologic competition.
The Federal Register Notice poses a series of questions about which the FTC seeks public comment. The FTC will take these comments into account in its examination of these topics.
Previous Biologics Workshops and Report:
December 10, 2013 Time: 9am – 5pm
601 New Jersey Avenue, NW
Ann Weaver Hart, President of the University of Arizona outlines the basics of the GME Crisis and offers a solution
Biomedical innovations in the area of molecular diagnostics are the framework for a new golden age of medicine. Unfortunately, a hurdle on the path from discovery to development to delivery could block these life sustaining and life saving innovations from getting to the patient.Continue reading
Read on for the latest Washington Rundown Continue reading
Koerber-Walker: Striking the Right Balance When Controlling Health Care CostsContinue reading
The non-binding 2014 Budget Resolution in the Senate represents the first Senate vote on the repealof the medical device excise tax and is an important expression of the Senate’s support for addressing the issue.
Last week, over 200 leaders from across the nation visited Washington D.C. to meet with their Congressional delegations and share ideas with our nation’s leaders on the importance of our bioindustry and on the issues that are key to moving innovation forward and providing access to these life sustaining and life saving innovations.Continue reading
When President Obama delivers the State of the Union address on Tuesday, he’ll be speaking to a polarized Congress where brinksmanship is the order of the day. If lawmakers don’t act by March 1, budget sequestration will slash funding for biomedical research and oversight of the nation’s food and drug products. Continue reading